Phase 1, safety, immunogenicity and dose finding for two strengths of 0.5 × 10^6 and 2.5 × 10^6 (TCID50) inactivated SARS-CoV-2 vaccine FAKHRAVAC (MIVAC) injected in two schedules of two doses, 2 and 3 weeks apart in healthy adults aged 18-55 years: a randomized, double blind, placebo controlled, clinical trial
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Protocol summary
Randomized, double blind, controlled trial with factorial design on 135 volunteers. Fifteen sentinels without blinding and 120 in 5 groups of 24, double blind and randomized
Randomized, double blind, controlled trial with parallel design on 135 volunteers. Fifteen sentinels without blinding and 120 in 5 groups of 24, double blind and randomized
Randomized, double blind, controlled trial with factorialparallel design on 135 volunteers. Fifteen sentinels without blinding and 120 in 5 groups of 24, double blind and randomized
کارآزمایی بالینی دارای گروه کنترل، با گروههای فاکتوریال بر روی 135 داوطلب که 15 نفر بصورت پیش قراول بدون کورسازی و 120 نفر در پنج گروه 24 نفری بصورت دو سو کور، و تصادفی شده وارد مطالعه می شوند.
کارآزمایی بالینی دارای گروه کنترل، با گروههای موازی بر روی 135 داوطلب که 15 نفر بصورت پیش قراول بدون کورسازی و 120 نفر در پنج گروه 24 نفری بصورت دو سو کور، و تصادفی شده وارد مطالعه می شوند.
کارآزمایی بالینی دارای گروه کنترل، با گروههای فاکتوریالموازی بر روی 135 داوطلب که 15 نفر بصورت پیش قراول بدون کورسازی و 120 نفر در پنج گروه 24 نفری بصورت دو سو کور، و تصادفی شده وارد مطالعه می شوند.
Fakhra clinical trial center, Persian Gulf Hall, Sased Sports Complex, Shahid Fakhrizadeh Street, Sayad Highway, Tehran, Iran
Fakhra clinical trial center, Persian Gulf Hall, Sased Sports Complex, Shahid Fakhrizadeh Street, Sayad Shirazi Highway, Tehran, Iran
Fakhra clinical trial center, Persian Gulf Hall, Sased Sports Complex, Shahid Fakhrizadeh Street, Sayad Shirazi Highway, Tehran, Iran
Inclusion criteria: Age 18-55 years; BMI 18-35; no abnormal clinical and laboratory findings; No current or previous infection with COVID-19; Use of safe methods of contraception; Signing informed consent form
Exclusion criteria: Current acute or chronic illness requiring regular medical or surgical attention; High-risk occupations exposed with Covid-19; serving in obligatory military service; Breastfeeding; Pregnancy;
Inclusion criteria: Age 18-55 years; BMI 18-35; no abnormal clinical and laboratory findings; No current or previous infection with COVID-19; Use of safe methods of contraception; Signing informed consent form
Exclusion criteria: Current acute or chronic illness requiring regular medical or surgical attention; High-risk occupations exposed with Covid-19; serving in obligatory military service; Breastfeeding; Pregnancy
Inclusion criteria: Age 18-55 years; BMI 18-35; no abnormal clinical and laboratory findings; No current or previous infection with COVID-19; Use of safe methods of contraception; Signing informed consent form Exclusion criteria: Current acute or chronic illness requiring regular medical or surgical attention; High-risk occupations exposed with Covid-19; serving in obligatory military service; Breastfeeding; Pregnancy;
معیارهای ورود: سن 18 تا 55 سال؛ شاخص توده بدنی بین 18 تا 35 کیلوگرم بر متر مربع؛ سلامت کامل بالینی و آزمایشگاهی؛ عدم ابتلا فعلی یا قبلی به کووید 19؛ استفاده از روشهای مطمئن پیشگیری از بارداری، امضای فرم رضایتنامه آگاهانه
معیارهای عدم ورود: ابتلا فعلی به بیماری علامتدار حاد یا مزمن که نیازمند مراقبت مداوم داخلی یا جراحی باشد؛ مشاغل پر خطر در معرض ابتلا به کووید-19؛ سرباز وظیفه؛ شیردهی؛ بارداری،
معیارهای ورود: سن 18 تا 55 سال؛ شاخص توده بدنی بین 18 تا 35 کیلوگرم بر متر مربع؛ سلامت کامل بالینی و آزمایشگاهی؛ عدم ابتلا فعلی یا قبلی به کووید 19؛ استفاده از روشهای مطمئن پیشگیری از بارداری، امضای فرم رضایتنامه آگاهانه
معیارهای عدم ورود: ابتلا فعلی به بیماری علامتدار حاد یا مزمن که نیازمند مراقبت مداوم داخلی یا جراحی باشد؛ مشاغل پر خطر در معرض ابتلا به کووید-19؛ سرباز وظیفه؛ شیردهی؛ بارداری
معیارهای ورود: سن 18 تا 55 سال؛ شاخص توده بدنی بین 18 تا 35 کیلوگرم بر متر مربع؛ سلامت کامل بالینی و آزمایشگاهی؛ عدم ابتلا فعلی یا قبلی به کووید 19؛ استفاده از روشهای مطمئن پیشگیری از بارداری، امضای فرم رضایتنامه آگاهانه معیارهای عدم ورود: ابتلا فعلی به بیماری علامتدار حاد یا مزمن که نیازمند مراقبت مداوم داخلی یا جراحی باشد؛ مشاغل پر خطر در معرض ابتلا به کووید-19؛ سرباز وظیفه؛ شیردهی؛ بارداری،
Primary outcomes: Reactogenicity (vital signs and anaphylactic reactions 3 hours post-vaccination; Local and systemic adverse events within the first week post-vaccination; Abnormal laboratory findings one week after
Secondary outcomes: SAEs, SUSARs, MAAEs up to six months after the last dose of the vaccine; Occurrence of Covid-19 disease two weeks after the second dose of the vaccine onward; Serum IgG level for SARS-CoV-2 to N and S antigens in 8 visits; Neutralizing antibody activity in 6 visits; Cell medicated immunity and safety of cell mediated immune response in 6 visits
Primary outcomes: Reactogenicity (vital signs and anaphylactic reactions 3 hours post-vaccination; Local and systemic adverse events within the first-week post-vaccination; Abnormal laboratory findings one week after each dose.
Secondary outcomes: SAEs, SUSARs, MAAEs up to six months after the last dose of the vaccine; Occurrence of Covid-19 disease two weeks after the second dose of the vaccine onwards; Serum IgG level for SARS-CoV-2 to N and S antigens; Neutralizing antibody activity; Cell medicated immunity and safety of cell-mediated immune response.
Primary outcomes: Reactogenicity (vital signs and anaphylactic reactions 3 hours post-vaccination; Local and systemic adverse events within the first-week post-vaccination; Abnormal laboratory findings one week after each dose. Secondary outcomes: SAEs, SUSARs, MAAEs up to six months after the last dose of the vaccine; Occurrence of Covid-19 disease two weeks after the second dose of the vaccine onwardonwards; Serum IgG level for SARS-CoV-2 to N and S antigens in 8 visits; Neutralizing antibody activity in 6 visits; Cell medicated immunity and safety of cell-mediated immune response in 6 visits.
General information
Recording of the actual start and end recruitment date;
Recording of vaccine concentrations in the intervention section;
Matching of inclusion and exclusion criteria according to the latest version of the protocol;
Correcting the number of visits according to the latest version of the protocol
Correcting English translation
Recording of the actual start and end recruitment date; Recording of vaccine concentrations in the intervention section; Matching of inclusion and exclusion criteria according to the latest version of the protocol; Correcting the number of visits according to the latest version of the protocolEnglish translation
اعلام تاریخ شروع و پایان بیمارگیری تحقق یافته؛
افزودن غلظت واکسن تزریقی در قسمت مداخلات؛
همسان سازی شرایط ورود و عدم ورود با آخرین نسخه پروتکل؛
اصلاح تعداد دفعات مراجعه با توجه به آخرین نسخه پروتکل
ویرایش نگارشی
اعلام تاریخ شروع و پایان بیمارگیری تحقق یافته؛ افزودن غلظت واکسن تزریقی در قسمت مداخلات؛ همسان سازی شرایط ورود و عدم ورود با آخرین نسخه پروتکل؛ اصلاح تعداد دفعات مراجعه با توجه به آخرین نسخه پروتکلویرایش نگارشی
trial of safety, immunogenicity and dose finding for inactivated SARS-CoV-2 vaccine FAKHRAVAC (MIVAC)
Safety, immunogenicity and dose finding for inactivated SARS-CoV-2 vaccine FAKHRAVAC (MIVAC)
trial of safetySafety, immunogenicity and dose finding for inactivated SARS-CoV-2 vaccine FAKHRAVAC (MIVAC)
Iranian citizenship, and residence at a distance of 40-50 km from the study setting
The ability of participants to study and understand informed consent, preferably educational level of high school and higher
Ages 18 to 55 years
Body mass index between 18 and 35 kg/m2
Complete health based on clinical and laboratory conditions
Temperature less than or equal to 37.2°C sublingually based on electronic thermometer
Negative IgG and IgM antibody titers against COVID-19 N antigen
Negative RT-PCR test to detect COVID-19
Negative ELISA test for anti-HIV IgG
Heart rate between 60 and 100
Systolic blood pressure between 90 and 140 mm Hg, diastolic blood pressure between 60 and 90 mm Hg
Signing informed consent
Accepting commitments to reduce the risk of COVID-19 infection
No pregnancy
Negative pregnancy test for β-hCG on the day of screening and the day of vaccination
The use of at least one safe method of contraception (condoms, oral contraceptive pills, IUD, Norplant capsule) for women of reproductive age 18 to 49 years
Willingness to continue using at least one safe method of contraception (condoms, oral contraceptive pills, IUD, Norplant capsule) for women of reproductive age 18 to 49 years up to three months after completion of the vaccination period
Participants in the clinical trial should refrain from donating blood or plasma from the time of the first vaccination until three months after the last vaccination.
Failure to participate in another trial during the present study
Expressing the readiness of the person to remain among the people monitored in the study for the entire study period until the end of the research process within 14 months
The use of one of the safest methods of contraception by married men up to three months after the last dose of vaccine
Iranian citizenship, and residing at a distance of 40-50 km from the study center
The ability of participants to study and understand informed consent, preferably educational level of high school and higher
Age between 18 and 55 years
Body mass index between 18 and 35 kg/m2
Being healthy based on clinical and laboratory examinations
Temperature less than or equal to 37.2°C sublingually measured by an electronic thermometer
Negative IgG and IgM antibody titers against COVID-19 N antigen
Negative RT-PCR test for COVID-19
Negative ELISA test for anti-HIV IgG
Heart rate between 60 and 100
Systolic blood pressure between 90 and 140 mm Hg, diastolic blood pressure between 60 and 90 mm Hg
Signing informed consent
Accepting commitments to reduce the risk of COVID-19 infection in daily life
Not pregnant
Negative β-hCG pregnancy test on the screening and vaccination days
The use of at least one safe method of contraception (condoms, oral contraceptive pills, IUD, Norplant capsule) for women of reproductive age 18 to 49 years
Willingness to continue using at least one safe method of contraception (condoms, oral contraceptive pills, IUD, Norplant capsule) for women of reproductive age 18 to 49 years up to three months after the second vaccine dose
Participants in the clinical trial should refrain from donating blood or plasma from the time of the first vaccine dose until three months after the second vaccine dose
should not participate in another trial during the study period
Expressing readiness to remain in the study for the entire study period
Married men should use safe methods of contraception up to three months after the second vaccine dose
Iranian citizenship, and residenceresiding at a distance of 40-50 km from the study settingcenter The ability of participants to study and understand informed consent, preferably educational level of high school and higher AgesAge between 18 toand 55 years Body mass index between 18 and 35 kg/m2 Complete healthBeing healthy based on clinical and laboratory conditionsexaminations Temperature less than or equal to 37.2°C sublingually based onmeasured by an electronic thermometer Negative IgG and IgM antibody titers against COVID-19 N antigen Negative RT-PCR test to detectfor COVID-19 Negative ELISA test for anti-HIV IgG Heart rate between 60 and 100 Systolic blood pressure between 90 and 140 mm Hg, diastolic blood pressure between 60 and 90 mm Hg Signing informed consent Accepting commitments to reduce the risk of COVID-19 infection No pregnancyin daily life Not pregnant Negative β-hCG pregnancy test for β-hCG on the day of screening and the day of vaccination days The use of at least one safe method of contraception (condoms, oral contraceptive pills, IUD, Norplant capsule) for women of reproductive age 18 to 49 years Willingness to continue using at least one safe method of contraception (condoms, oral contraceptive pills, IUD, Norplant capsule) for women of reproductive age 18 to 49 years up to three months after completion of the vaccination periodsecond vaccine dose Participants in the clinical trial should refrain from donating blood or plasma from the time of the first vaccinationvaccine dose until three months after the last vaccination. Failure tosecond vaccine dose should not participate in another trial during the present study period Expressing the readiness of the person to remain among the people monitored in the study for the entire study period until the end of the research process within 14 months TheMarried men should use of one of the safestsafe methods of contraception by married men up to three months after the lastsecond vaccine dose of vaccine
داشتن تابعیت ایرانی و محل سکونت با فاصله 40-50 کیلومتری از محل انجام مطالعه
شرکت کنندگان توانایی مطالعه و درک رضایتنامه آگاهانه را داشته باشند، ترجیحا داشتن تحصیلات دیپلم و بالاتر
سن 18 تا 55 سال
شاخص توده بدنی بین 18 تا 35 کیلوگرم بر متر مربع
دارا بودن سلامتی کامل بر اساس سابقه پزشکی، شرایط بالینی و آزمایشگاهی
درجه¬ی حرارت کمتر یا مساوی 37.2 درجه سانتی گراد زیر زبانی بر اساس تب سنج الکترونیک
منفی بودن تیتر آنتی بادی IgG و IgM برعلیه آنتی ژن N کووید-19
منفی بودن تست RT-PCR برای تشخیص کووید-19
تست خونی منفی الایزا IgG برعلیه HIV
تعداد ضربان قلب بین 60 تا 100
فشار خون سیستولیک (بین 90 تا 140 میلی متر جیوه)، فشار خون دیاستولیک (بین 60 تا 90 میلی متر جیوه)
امضای فرم رضایت نامه آگاهانه
قبول تعهدات مربوط به کاهش احتمال ابتلا به کووید 19
باردار نبودن
تست منفی بارداری β-hCG در روز غربالگری و روز واکسیناسیون
استفاده از حداقل یکی از روش های مطمئن ضد بارداری (کاندوم، قرص های خوراکی پیشگیری از بارداری، وسیله پیشگیری از بارداری داخل رحمی IUD، کپسول نورپلنت) برای خانم های در سنین باروری 18 تا 49 سال
تمایل به ادامه استفاده از حداقل یکی از روش های مطمئن ضد بارداری (کاندوم، قرص های خوراکی پیشگیری از بارداری، وسیله پیشگیری از بارداری داخل رحمی IUD، کپسول نورپلنت) برای خانم های در سنین باروری 18 تا 49 سال تا 3 ماه بعد از اتمام دوره واکسیناسیون
شرکت کنندگان در کارآزمائی بالینی باید از زمان اولین واکسیناسیون تا 3 ماه پس از آخرین واکسیناسیون از اهدای خون یا پلاسما خودداری کنند.
عدم شرکت فرد در کارآزمایی دیگر در طول مطالعه حاضر
ابراز آمادگی فرد برای ماندن جزو افراد مورد پایش در مطالعه برای کل مدت مطالعه تا مراحل تحقیق طی 14 ماه پایان پذیرد.
استفاده از یکی از روش های مطمئن پیشگیری از بارداری در مردان متاهل تا 3 ماه بعد از آخرین دوز واکسن
داشتن تابعیت ایرانی و محل سکونت با فاصله 40-50 کیلومتری از محل انجام مطالعه
شرکت کنندگان توانایی مطالعه و درک رضایتنامه آگاهانه را داشته باشند، ترجیحا داشتن تحصیلات دیپلم و بالاتر
سن 18 تا 55 سال
شاخص توده بدنی بین 18 تا 35 کیلوگرم بر متر مربع
دارا بودن سلامتی کامل بر اساس سابقه پزشکی، شرایط بالینی و آزمایشگاهی
درجه¬ی حرارت کمتر یا مساوی 37.2 درجه سانتی گراد زیر زبانی بر اساس تب سنج الکترونیک
منفی بودن تیتر آنتی بادی IgG و IgM برعلیه آنتی ژن N کووید-19
منفی بودن تست RT-PCR برای تشخیص کووید-19
تست خونی منفی الایزا IgG برعلیه HIV
تعداد ضربان قلب بین 60 تا 100
فشار خون سیستولیک (بین 90 تا 140 میلی متر جیوه)، فشار خون دیاستولیک (بین 60 تا 90 میلی متر جیوه)
امضای فرم رضایت نامه آگاهانه
قبول تعهدات مربوط به کاهش احتمال ابتلا به کووید 19
باردار نبودن
تست منفی بارداری β-hCG در روز غربالگری و روز واکسیناسیون
استفاده از حداقل یکی از روش های مطمئن ضد بارداری (کاندوم، قرص های خوراکی پیشگیری از بارداری، وسیله پیشگیری از بارداری داخل رحمی IUD، کپسول نورپلنت) برای خانم های در سنین باروری 18 تا 49 سال
تمایل به ادامه استفاده از حداقل یکی از روش های مطمئن ضد بارداری (کاندوم، قرص های خوراکی پیشگیری از بارداری، وسیله پیشگیری از بارداری داخل رحمی IUD، کپسول نورپلنت) برای خانم های در سنین باروری 18 تا 49 سال تا 3 ماه بعد از اتمام دوره واکسیناسیون
شرکت کنندگان در کارآزمائی بالینی باید از زمان اولین واکسیناسیون تا 3 ماه پس از آخرین واکسیناسیون از اهدای خون یا پلاسما خودداری کنند.
عدم شرکت فرد در کارآزمایی دیگر در طول مطالعه حاضر
ابراز آمادگی فرد برای ماندن جزو افراد مورد پایش در مطالعه برای کل مدت مطالعه
استفاده از یکی از روش های مطمئن پیشگیری از بارداری در مردان متاهل تا 3 ماه بعد از آخرین دوز واکسن
داشتن تابعیت ایرانی و محل سکونت با فاصله 40-50 کیلومتری از محل انجام مطالعه شرکت کنندگان توانایی مطالعه و درک رضایتنامه آگاهانه را داشته باشند، ترجیحا داشتن تحصیلات دیپلم و بالاتر سن 18 تا 55 سال شاخص توده بدنی بین 18 تا 35 کیلوگرم بر متر مربع دارا بودن سلامتی کامل بر اساس سابقه پزشکی، شرایط بالینی و آزمایشگاهی درجه¬ی حرارت کمتر یا مساوی 37.2 درجه سانتی گراد زیر زبانی بر اساس تب سنج الکترونیک منفی بودن تیتر آنتی بادی IgG و IgM برعلیه آنتی ژن N کووید-19 منفی بودن تست RT-PCR برای تشخیص کووید-19 تست خونی منفی الایزا IgG برعلیه HIV تعداد ضربان قلب بین 60 تا 100 فشار خون سیستولیک (بین 90 تا 140 میلی متر جیوه)، فشار خون دیاستولیک (بین 60 تا 90 میلی متر جیوه) امضای فرم رضایت نامه آگاهانه قبول تعهدات مربوط به کاهش احتمال ابتلا به کووید 19 باردار نبودن تست منفی بارداری β-hCG در روز غربالگری و روز واکسیناسیون استفاده از حداقل یکی از روش های مطمئن ضد بارداری (کاندوم، قرص های خوراکی پیشگیری از بارداری، وسیله پیشگیری از بارداری داخل رحمی IUD، کپسول نورپلنت) برای خانم های در سنین باروری 18 تا 49 سال تمایل به ادامه استفاده از حداقل یکی از روش های مطمئن ضد بارداری (کاندوم، قرص های خوراکی پیشگیری از بارداری، وسیله پیشگیری از بارداری داخل رحمی IUD، کپسول نورپلنت) برای خانم های در سنین باروری 18 تا 49 سال تا 3 ماه بعد از اتمام دوره واکسیناسیون شرکت کنندگان در کارآزمائی بالینی باید از زمان اولین واکسیناسیون تا 3 ماه پس از آخرین واکسیناسیون از اهدای خون یا پلاسما خودداری کنند. عدم شرکت فرد در کارآزمایی دیگر در طول مطالعه حاضر ابراز آمادگی فرد برای ماندن جزو افراد مورد پایش در مطالعه برای کل مدت مطالعه تا مراحل تحقیق طی 14 ماه پایان پذیرد. استفاده از یکی از روش های مطمئن پیشگیری از بارداری در مردان متاهل تا 3 ماه بعد از آخرین دوز واکسن
History (at the time of referral) of any acute or chronic symptomatic disease requiring ongoing internal care or surgery
Belonging to medical staff or health care workers
Breastfeeding
History of receiving any vaccine (whether investigational or non-investigational) within 30 days prior to screening
History of receiving other investigational drugs during the last 60 days (before the start of the present clinical trial)
History of receiving blood or any blood product or immunoglobulin within three months before screening
History of Immunodeficiency disorders (suspected and definite)
History of long-term use of immunosuppressive drugs (more than 14 consecutive days) within four months prior to screening
History of long-term use (more than 14 consecutive days) of systemic corticosteroids (equivalent to 10 mg or more daily prednisolone) or (high-dose inhaled steroids (more than 800 µg/day of beclomethasone dipropionate or equivalent) within four months prior to screening (excluding topical steroids)
History of allergic diseases such as angioedema or anaphylaxis
History of any known allergy to the drug or vaccine carriers (whether alum or albumin)
History of known allergy to eggs
History of autoimmune diseases
Chemotherapy or radiotherapy in the last 5 years
History of cancer in the last 5 years
History of serious psychiatric illnesses
History of blood disorders (dyscrasia, coagulation disorders, platelet deficiency or disorder, deficiency of blood factors)
History of chronic obstructive pulmonary disease such as asthma, ischemic heart disease definitively diagnosed by a specialist
History of ischemic heart disease treated by a physician or history of cardiac interventions by a physician
History of hypertension treated by a physician
History of diabetes treated by a physician
History of congenital anomalies, growth retardation, genetic defects or severe malnutrition
Individual and family history of chronic neurological diseases (including seizures and epilepsy)
History of thyroid disease or Thyroidectomy
Any history of substance or alcohol abuse in the past 2 years
Any defect in the results of hematology or biochemical tests performed at the time of screening
History of confirmed COVID-19
Acute febrile illness at the time of vaccination
History of allergy to acetaminophen
History of acute or chronic hepatitis B and C
History of pulmonary or extrapulmonary tuberculosis or receiving antituberculous agents
Taking prophylactic antitubercular drugs
History of syncope during injection or blood drawing
Splenectomy for any reason or history of abnormal spleen function
Any close contact with a person with confirmed COVID-19 for a maximum of two weeks before the day of receiving the first vaccine dose
Previous history of diseases such as SARS and MERS
Ineligibility to participate in a clinical trial for any reason at the discretion of the researchers
Employment as military service in the subdivisions of the Armed Forces
Any acute or chronic symptomatic disease requiring ongoing medical or surgical care at the screening day
Healthcare workers
Breastfeeding
History of receiving any vaccine (whether investigational or non-investigational) within 30 days prior to the screening day
History of receiving other investigational drugs within 60 days prior to the screening day
History of receiving blood or any blood product or immunoglobulin within three months prior to the screening day
History of Immunodeficiency disorders (suspected or definite)
History of long-term use of immunosuppressive drugs (more than 14 consecutive days) within four months prior to the screening day
History of long-term use (more than 14 consecutive days) of systemic corticosteroids (equivalent to 10 mg or more daily prednisolone) or high-dose inhaled steroids (more than 800 µg/day of beclomethasone dipropionate or equivalent) within four months prior to the screening day (excluding topical steroids)
History of allergic diseases such as angioedema or anaphylaxis
History of any known allergy to drugs or vaccines including aluminum phosphate and albumin
History of known allergy to eggs
History of autoimmune diseases
Chemotherapy or radiotherapy in the last 5 years
History of cancer in the last 5 years
History of serious psychiatric illnesses
History of blood disorders (dyscrasia, coagulation disorders, platelet deficiency or disorder, deficiency of blood factors)
History of chronic obstructive pulmonary disease such as asthma diagnosed by a specialist
History of ischemic heart disease currently treated by a cardiologist or receiving any cardiac interventions
History of hypertension currently treated by a physician
History of diabetes currently treated by a physician
Congenital anomalies, growth retardation, genetic defects or severe malnutrition
Individual or family history of chronic neurological diseases (including seizures and epilepsy)
History of thyroid disease or Thyroidectomy
Any history of substance or alcohol abuse in the past 2 years
Abnormal hematological or biochemical test results at the time of screening
History of confirmed COVID-19
Acute febrile illness at the time of vaccination
History of allergy to acetaminophen
History of acute or chronic hepatitis B and C
History of pulmonary or extrapulmonary tuberculosis or receiving antituberculotic treatment
Receiving tuberculosis prophylaxis
History of faint in any encounter with needles or phlebectomy
Splenectomy for any reason or history of abnormal spleen function
Any close contact with a confirmed COVID-19 case up to two weeks before receiving the first vaccine dose
Previous history of diseases such as SARS and MERS
Not fit to participate in the trial (the decision is at the discretion of the chief investigator)
People who are currently serving their obligatory military service in the Armed Forces
History (at the time of referral) of anyAny acute or chronic symptomatic disease requiring ongoing internalmedical or surgical care or surgery Belonging to medical staff or health careat the screening day Healthcare workers Breastfeeding History of receiving any vaccine (whether investigational or non-investigational) within 30 days prior to the screening day History of receiving other investigational drugs during the lastwithin 60 days (beforeprior to the start of the present clinical trial)screening day History of receiving blood or any blood product or immunoglobulin within three months beforeprior to the screening day History of Immunodeficiency disorders (suspected andor definite) History of long-term use of immunosuppressive drugs (more than 14 consecutive days) within four months prior to the screening day History of long-term use (more than 14 consecutive days) of systemic corticosteroids (equivalent to 10 mg or more daily prednisolone) or (high-dose inhaled steroids (more than 800 µg/day of beclomethasone dipropionate or equivalent) within four months prior to the screening day (excluding topical steroids) History of allergic diseases such as angioedema or anaphylaxis History of any known allergy to the drugdrugs or vaccine carriers (whether alum orvaccines including aluminum phosphate and albumin) History of known allergy to eggs History of autoimmune diseases Chemotherapy or radiotherapy in the last 5 years History of cancer in the last 5 years History of serious psychiatric illnesses History of blood disorders (dyscrasia, coagulation disorders, platelet deficiency or disorder, deficiency of blood factors) History of chronic obstructive pulmonary disease such as asthma, ischemic heart disease definitively diagnosed by a specialist History of ischemic heart disease currently treated by a physiciancardiologist or history ofreceiving any cardiac interventions by a physician History of hypertension currently treated by a physician History of diabetes currently treated by a physician History of congenitalCongenital anomalies, growth retardation, genetic defects or severe malnutrition Individual andor family history of chronic neurological diseases (including seizures and epilepsy) History of thyroid disease or Thyroidectomy Any history of substance or alcohol abuse in the past 2 years Any defect in the results of hematologyAbnormal hematological or biochemical tests performedtest results at the time of screening History of confirmed COVID-19 Acute febrile illness at the time of vaccination History of allergy to acetaminophen History of acute or chronic hepatitis B and C History of pulmonary or extrapulmonary tuberculosis or receiving antituberculous agents Taking prophylactic antitubercular drugsantituberculotic treatment Receiving tuberculosis prophylaxis History of syncope during injectionfaint in any encounter with needles or blood drawingphlebectomy Splenectomy for any reason or history of abnormal spleen function Any close contact with a person with confirmed COVID-19 for a maximum ofcase up to two weeks before the day of receiving the first vaccine dose Previous history of diseases such as SARS and MERS IneligibilityNot fit to participate in a clinicalthe trial for any reason(the decision is at the discretion of the researchers Employment aschief investigator) People who are currently serving their obligatory military service in the subdivisions of the Armed Forces
داشتن (در زمان مراجعه) هر نوع بیماری علامت دار حاد یا مزمن که نیازمند مراقبت مداوم داخلی یا جراحی در حال حاضر باشد
کسانی که کادر درمان هستند یا از کارکنان مراقبت های بهداشتی به شمار می روند.
شیردهی
سابقه ی دریافت هرگونه واکسن (اعم از تحقیقاتی یا غیر تحقیقاتی) در طی 30 روز قبل از روز غربالگری
سابقه دریافت سایر داروهای تحقیقاتی طی 60 روز گذشته (قبل از شروع کارآزمائی بالینی حاضر)
سابقه ی دریافت خون و یا هرنوع فرآورده ی خونی و یا ایمنوگلوبولین در ظرف 3 ماه قبل از روز غربالگری
ابتلا به بیماری های کاهش دهنده ی سیستم ایمنی (مشکوک و قطعی)
سابقه ی مصرف طولانی مدت داروهای کاهنده ی سیستم ایمنی (بیش از 14 روز پشت سرهم) در 4 ماه اخیر منتهی به روز غربالگری
سابقه ی مصرف طولانی مدت (بیش از 14 روز پشت سرهم) کورتیکواستروئید های سیستمیک (معادل10 میلی گرم یا بیشتر روزانه پردنیزولون ) و یا (استروئیدهای استنشاقی با دوز بالا (بیش از 800 میکروگرم در روز بکلومتازون دیپروپیونات یا معادل آن) در 4 ماه اخیر منتهی به روز غربالگری (به استثنای مصرف استروئیدهای موضعی)
سابقه ی ابتلا به بیماری های آلرژیک از جمله آنژیو ادم و یا واکنش های آنافیلاکسی
سابقه ی هر نوع حساسیت شناخته شده به دارو و یا حاملین واکسن (اعم از آلوم یا آلبومین)
سابقه حساسیت شناخته شده به تخم مرغ
سابقه ی ابتلا به بیماری های اتوایمیون
شیمی درمانی یا پرتودرمانی در عرض 5 سال اخیر
سابقه ابتلا به سرطان در 5 سال گذشته
سابقه ی ابتلا به بیماری های جدی روانپزشکی
سابقه ی ابتلا به اختلالات خونی ( دیسکرازی، انعقادی، کمبود یا اختلال پلاکت، کمبود فاکتورهای خونی)
ابتلا به بیماریهای مزمن انسدادی ریه از قبیل آسم و COPD که توسط پزشک متخصص تشخیص داده شده باشد.
ابتلا به بیماریهای ایسکمیک قلبی عروقی که توسط پزشک تحت درمان باشد یا داشتن سابقه مداخلات قلبی توسط پزشک cardiac interventions
ابتلا به فشار خون که توسط پزشک تحت درمان باشد.
ابتلا به دیابت که توسط پزشک تحت درمان باشد.
افراد دارای ناهنجاری مادرزادی، اختلال رشد، نقص ژنتیکی یا سوء تغذیه شدید
سابقه ابتلا فرد یا خانواده وی به بیماریهای نورولوژیک مزمن (از جمله تشنج و صرع )
کسانی که بیماری تیروئید یا سابقه برداشتن غده تیروئید داشته باشند.
هرگونه سابقه ی سوء مصرف (اعتیاد) مواد و یا الکل در عرض 2 سال گذشته
هرگونه اختلال یا اشکال در نتایج آزمایشات هماتولوژی و یا بیوشیمی انجام گرفته در زمان غربالگری
سابقه ی ابتلا به کووید-19 تایید شده
ابتلا به بیماری حاد تب دار در زمان تزریق واکسن
سابقه حساسیت به قرص استامینوفن
ابتلا به هپاتیت B وC حاد یا مزمن
ابتلا به سل ریوی یا خارج ریوی یا در حال دریافت درمان ضد سل
دریافت داروی پروفیلاکسی ضد سل
سابقه سنکوپ با تزریق و یا مشاهده خون
فردی که به هرعلت اسپلنکتومی شده است یا طحال عملکرد غیر طبیعی شناخته شده دارد.
هرگونه تماس نزدیک با فرد مبتلا ی قطعی به کووید-19 در مدت حداکثر دو هفته قبل از روز دریافت دوز اول واکسن
سابقه قبلی ابتلا به بیماری های مانند سارس ، مرس
کسانیکه به هر دلیلی به تشخیص پژوهشگران، شرایط لازم برای حضور در کارآزمائی بالینی را نداشته باشند.
اشتغال بصورت وظیفه (سربازان) در زیرمجموعه های نیروهای مسلح
داشتن (در زمان مراجعه) هر نوع بیماری علامت دار حاد یا مزمن که نیازمند مراقبت مداوم داخلی یا جراحی در حال حاضر باشد
کسانی که کادر درمان هستند یا از کارکنان مراقبت های بهداشتی به شمار می روند.
شیردهی
سابقه ی دریافت هرگونه واکسن (اعم از تحقیقاتی یا غیر تحقیقاتی) در طی 30 روز قبل از روز غربالگری
سابقه دریافت سایر داروهای تحقیقاتی طی 60 روز گذشته (قبل از شروع کارآزمائی بالینی حاضر)
سابقه ی دریافت خون و یا هرنوع فرآورده ی خونی و یا ایمنوگلوبولین در ظرف 3 ماه قبل از روز غربالگری
ابتلا به بیماری های کاهش دهنده ی سیستم ایمنی (مشکوک یا قطعی)
سابقه ی مصرف طولانی مدت داروهای کاهنده ی سیستم ایمنی (بیش از 14 روز پشت سرهم) در 4 ماه اخیر منتهی به روز غربالگری
سابقه ی مصرف طولانی مدت (بیش از 14 روز پشت سرهم) کورتیکواستروئید های سیستمیک (معادل 10 میلی گرم یا بیشتر روزانه پردنیزولون) و یا استروئیدهای استنشاقی با دوز بالا (بیش از 800 میکروگرم در روز بکلومتازون دیپروپیونات یا معادل آن) در 4 ماه اخیر منتهی به روز غربالگری (به استثنای مصرف استروئیدهای موضعی)
سابقه ی ابتلا به بیماری های آلرژیک از جمله آنژیو ادم و یا واکنش های آنافیلاکسی
سابقه ی هر نوع حساسیت شناخته شده به دارو و یا حاملین واکسن (اعم از آلوم یا آلبومین)
سابقه حساسیت شناخته شده به تخم مرغ
سابقه ی ابتلا به بیماری های اتوایمیون
شیمی درمانی یا پرتودرمانی در عرض 5 سال اخیر
سابقه ابتلا به سرطان در 5 سال گذشته
سابقه ی ابتلا به بیماری های جدی روانپزشکی
سابقه ی ابتلا به اختلالات خونی ( دیسکرازی، انعقادی، کمبود یا اختلال پلاکت، کمبود فاکتورهای خونی)
ابتلا به بیماریهای مزمن انسدادی ریه از قبیل آسم و COPD که توسط پزشک متخصص تشخیص داده شده باشد.
ابتلا به بیماریهای ایسکمیک قلبی عروقی که توسط پزشک تحت درمان باشد یا داشتن سابقه مداخلات قلبی توسط پزشک cardiac interventions
ابتلا به فشار خون که توسط پزشک تحت درمان باشد.
ابتلا به دیابت که توسط پزشک تحت درمان باشد.
افراد دارای ناهنجاری مادرزادی، اختلال رشد، نقص ژنتیکی یا سوء تغذیه شدید
سابقه ابتلا فرد یا خانواده وی به بیماریهای نورولوژیک مزمن (از جمله تشنج و صرع )
کسانی که بیماری تیروئید یا سابقه برداشتن غده تیروئید داشته باشند.
هرگونه سابقه ی سوء مصرف (اعتیاد) مواد و یا الکل در عرض 2 سال گذشته
هرگونه اختلال یا اشکال در نتایج آزمایشات هماتولوژی و یا بیوشیمی انجام گرفته در زمان غربالگری
سابقه ی ابتلا به کووید-19 تایید شده
ابتلا به بیماری حاد تب دار در زمان تزریق واکسن
سابقه حساسیت به قرص استامینوفن
ابتلا به هپاتیت B وC حاد یا مزمن
ابتلا به سل ریوی یا خارج ریوی یا در حال دریافت درمان ضد سل
دریافت داروی پروفیلاکسی ضد سل
سابقه سنکوپ با تزریق و یا مشاهده خون
فردی که به هرعلت اسپلنکتومی شده است یا طحال عملکرد غیر طبیعی شناخته شده دارد
هرگونه تماس نزدیک با فرد مبتلا ی قطعی به کووید-19 در مدت حداکثر دو هفته قبل از روز دریافت دوز اول واکسن
سابقه قبلی ابتلا به بیماری های مانند سارس ، مرس
کسانیکه به هر دلیلی به تشخیص پژوهشگران، شرایط لازم برای حضور در کارآزمائی بالینی را نداشته باشند
اشتغال بصورت وظیفه (سربازان) در زیرمجموعه های نیروهای مسلح
داشتن (در زمان مراجعه) هر نوع بیماری علامت دار حاد یا مزمن که نیازمند مراقبت مداوم داخلی یا جراحی در حال حاضر باشد کسانی که کادر درمان هستند یا از کارکنان مراقبت های بهداشتی به شمار می روند. شیردهی سابقه ی دریافت هرگونه واکسن (اعم از تحقیقاتی یا غیر تحقیقاتی) در طی 30 روز قبل از روز غربالگری سابقه دریافت سایر داروهای تحقیقاتی طی 60 روز گذشته (قبل از شروع کارآزمائی بالینی حاضر) سابقه ی دریافت خون و یا هرنوع فرآورده ی خونی و یا ایمنوگلوبولین در ظرف 3 ماه قبل از روز غربالگری ابتلا به بیماری های کاهش دهنده ی سیستم ایمنی (مشکوک ویا قطعی) سابقه ی مصرف طولانی مدت داروهای کاهنده ی سیستم ایمنی (بیش از 14 روز پشت سرهم) در 4 ماه اخیر منتهی به روز غربالگری سابقه ی مصرف طولانی مدت (بیش از 14 روز پشت سرهم) کورتیکواستروئید های سیستمیک (معادل10معادل 10 میلی گرم یا بیشتر روزانه پردنیزولون) و یا (استروئیدهای استنشاقی با دوز بالا (بیش از 800 میکروگرم در روز بکلومتازون دیپروپیونات یا معادل آن) در 4 ماه اخیر منتهی به روز غربالگری (به استثنای مصرف استروئیدهای موضعی) سابقه ی ابتلا به بیماری های آلرژیک از جمله آنژیو ادم و یا واکنش های آنافیلاکسی سابقه ی هر نوع حساسیت شناخته شده به دارو و یا حاملین واکسن (اعم از آلوم یا آلبومین) سابقه حساسیت شناخته شده به تخم مرغ سابقه ی ابتلا به بیماری های اتوایمیون شیمی درمانی یا پرتودرمانی در عرض 5 سال اخیر سابقه ابتلا به سرطان در 5 سال گذشته سابقه ی ابتلا به بیماری های جدی روانپزشکی سابقه ی ابتلا به اختلالات خونی ( دیسکرازی، انعقادی، کمبود یا اختلال پلاکت، کمبود فاکتورهای خونی) ابتلا به بیماریهای مزمن انسدادی ریه از قبیل آسم و COPD که توسط پزشک متخصص تشخیص داده شده باشد. ابتلا به بیماریهای ایسکمیک قلبی عروقی که توسط پزشک تحت درمان باشد یا داشتن سابقه مداخلات قلبی توسط پزشک cardiac interventions ابتلا به فشار خون که توسط پزشک تحت درمان باشد. ابتلا به دیابت که توسط پزشک تحت درمان باشد. افراد دارای ناهنجاری مادرزادی، اختلال رشد، نقص ژنتیکی یا سوء تغذیه شدید سابقه ابتلا فرد یا خانواده وی به بیماریهای نورولوژیک مزمن (از جمله تشنج و صرع ) کسانی که بیماری تیروئید یا سابقه برداشتن غده تیروئید داشته باشند. هرگونه سابقه ی سوء مصرف (اعتیاد) مواد و یا الکل در عرض 2 سال گذشته هرگونه اختلال یا اشکال در نتایج آزمایشات هماتولوژی و یا بیوشیمی انجام گرفته در زمان غربالگری سابقه ی ابتلا به کووید-19 تایید شده ابتلا به بیماری حاد تب دار در زمان تزریق واکسن سابقه حساسیت به قرص استامینوفن ابتلا به هپاتیت B وC حاد یا مزمن ابتلا به سل ریوی یا خارج ریوی یا در حال دریافت درمان ضد سل دریافت داروی پروفیلاکسی ضد سل سابقه سنکوپ با تزریق و یا مشاهده خون فردی که به هرعلت اسپلنکتومی شده است یا طحال عملکرد غیر طبیعی شناخته شده دارد. هرگونه تماس نزدیک با فرد مبتلا ی قطعی به کووید-19 در مدت حداکثر دو هفته قبل از روز دریافت دوز اول واکسن سابقه قبلی ابتلا به بیماری های مانند سارس ، مرس کسانیکه به هر دلیلی به تشخیص پژوهشگران، شرایط لازم برای حضور در کارآزمائی بالینی را نداشته باشند. اشتغال بصورت وظیفه (سربازان) در زیرمجموعه های نیروهای مسلح
In this study, the Block Randomization method with different block sizes was used to assign each participant to the intervention groups. The rand() function of Excel software will be used to generate random sequence within each block. After determining the allocated intervention, a non-repetitive four-digit random code was assigned to each participant. Assigned codes will be delivered to the eligible participants via a software.
In this study, the Block Randomization method with different block sizes was used to assign each participant to the intervention groups. The rand() function of Excel software will be used to generate a random sequence within each block. After determining the allocated intervention, each participant was assigned a non-repetitive four-digit random code. Assigned codes will be delivered to the eligible participants via study software.
In this study, the Block Randomization method with different block sizes was used to assign each participant to the intervention groups. The rand() function of Excel software will be used to generate a random sequence within each block. After determining the allocated intervention, each participant was assigned a non-repetitive four-digit random code was assigned to each participant. Assigned codes will be delivered to the eligible participants via astudy software.
In this study, placebo will be used. Adjunct only IMP will be used as placebo. All people involved in the study will be blind to the type of IMP received except the epidemiologist responsible for unblinding. In cases of any serious adverse event or any trend in the occurrence of adverse events towards one of the groups, unblinding will occur by DSMB request. In other clinical occasions unblinding could occur by the principle investigators' approval
In this study, a placebo will be used. Adjuvant-only IMP will be used as a placebo. All people involved in the study will be blind to the type of IMP received except the epidemiologist responsible for unblinding. In cases of any serious adverse event or any trend in the occurrence of adverse events towards one of the groups, unblinding will occur by DSMB request. On other clinical occasions, unblinding could occur with the principal investigators' approval.
In this study, a placebo will be used. Adjunct Adjuvant-only IMP will be used as a placebo. All people involved in the study will be blind to the type of IMP received except the epidemiologist responsible for unblinding. In cases of any serious adverse event or any trend in the occurrence of adverse events towards one of the groups, unblinding will occur by DSMB request. InOn other clinical occasions, unblinding could occur bywith the principleprincipal investigators' approval.
Primary outcomes
#1
Temperature is measured using a digital thermometer under the tongue. Heart rate and respiratory rate will be counted by the research staff in one minute. Blood pressure will be measured by a digital sphygmomanometer while sitting.
Sublingual temperature is measured using a digital thermometer. Heart rate and respiratory rate will be counted by the research staff in one minute. Blood pressure will be measured using a digital sphygmomanometer in sitting position.
TemperatureSublingual temperature is measured using a digital thermometer under the tongue. Heart rate and respiratory rate will be counted by the research staff in one minute. Blood pressure will be measured byusing a digital sphygmomanometer whilein sitting position.
#2
For the first 7 days after each vaccination
In the first seven days after each vaccine dose
ForIn the first 7seven days after each vaccinationvaccine dose
Study staff will contact participants daily for seven days and complete a local adverse event form.
Daily telephone contacts by the research team for seven days
Study staff will contact participants dailyDaily telephone contacts by the research team for seven days and complete a local adverse event form.
#3
For the first 7 days after each vaccination and then monthly for up to six months
In the first seven days after each vaccine dose and then monthly for up to six months
ForIn the first 7seven days after each vaccinationvaccine dose and then monthly for up to six months
Study staff will contact participants daily for seven days and complete a systemic adverse event form.
Telephone contacts by the research team
Study staff will contact participants daily for seven days and complete a systemic adverse event form.Telephone contacts by the research team
Complications will be assessed by telephone each month
Monthly follow-up by the research team
Complications will be assessedMonthly follow-up by telephone each monththe research team
ارزیابی عوارض ماهانه به صورت تلفنی انجام خواهد گرفت.
ارزیابی عوارض ماهانه توسط تیم پژوهش انجام خواهد گرفت.
ارزیابی عوارض ماهانه به صورت تلفنیتوسط تیم پژوهش انجام خواهد گرفت.
#2
In the vaccination program 0-14: on days zero, 7, 14, 28, 42, 72 and months 3, 6 and in the vaccination program 21-0: on days zero, 7, 14, 21, 35, 49 and months 3, 6.
In the vaccination schedule 0-14: on days zero, 7, 14, 28, 42, 72 and months 3, 6. In the vaccination schedule 0-21: on days zero, 7, 14, 21, 35, 49 and months 3, 6.
In the vaccination programschedule 0-14: on days zero, 7, 14, 28, 42, 72 and months 3, 6 and in. In the vaccination program schedule 0-21-0: on days zero, 7, 14, 21, 35, 49 and months 3, 6.
#3
In the vaccination program 0-14: on days zero, 14, 28, 42 and months 3, 6 and in the vaccination program 21-0: on days zero, 21, 35, 49 and months 3, 6.
In the vaccination schedule 0-14: on days zero, 14, 28, 42 and months 3, 6. In the vaccination schedule 0-21: on days zero, 21, 35, 49 and months 3, 6.
In the vaccination programschedule 0-14: on days zero, 14, 28, 42 and months 3, 6 and in. In the vaccination program schedule 0-21-0: on days zero, 21, 35, 49 and months 3, 6.
SARS-CoV-2 virus neutralizing antibody titer
Conventional SARS-CoV-2 virus neutralizing antibody test
Cell-mediated immunity and cell immunogenicity safety
Cell-mediated immunity and safety of the immune response
Cell-mediated immunity and cell immunogenicity safety of the immune response
In the vaccination program 0-14: on days zero, 14, 28, 42 and months 3, 6 and in the vaccination program 21-0: on days zero, 21, 35, 49 and months 3, 6 . This outcome will be measured on day 0 and 2 weeks after the second injection for all volunteers and at other time points for 20% of participants.
In the vaccination schedule 0-14: on days zero, 14, 28, 42 and months 3, 6. In the vaccination schedule 0-21: on days zero, 21, 35, 49 and months 3, 6. This outcome will be measured on day zero and two weeks after the second injection for all volunteers and at other time points for 20% of the participants.
In the vaccination programschedule 0-14: on days zero, 14, 28, 42 and months 3, 6 and in. In the vaccination program schedule 0-21-0: on days zero, 21, 35, 49 and months 3, 6. This outcome will be measured on day 0zero and 2two weeks after the second injection for all volunteers and at other time points for 20% of the participants.
Absolute measurement of lymphocyte cell subpopulations (B, T, NK) and their ratio, measurement of T cell subpopulations (CD3 + CD4 +, CD3 + CD8 +), measurement of TNF-a and interleukins 4, 5, 2, 17, 6, 12, 17A, 17F, 21, 8 and 10. Cell proliferation using CFSE method. Measurement of intracellular gamma interferon (interleukin-4 and TNF-alpha) in antigen-exposed CD4 and CD8 cells
Absolute measurement of lymphocyte cell subpopulations (B, T, NK) and their ratio, measurement of T cell subpopulations (CD3 + CD4 +, CD3 + CD8 +), measurement of TNF-a and interleukins 4, 5, 2, 17, 6, 12, 17A, 17F, 21, 8 and 10.
Absolute measurement of lymphocyte cell subpopulations (B, T, NK) and their ratio, measurement of T cell subpopulations (CD3 + CD4 +, CD3 + CD8 +), measurement of TNF-a and interleukins 4, 5, 2, 17, 6, 12, 17A, 17F, 21, 8 and 10. Cell proliferation using CFSE method. Measurement of intracellular gamma interferon (interleukin-4 and TNF-alpha) in antigen-exposed CD4 and CD8 cells
اندازه گیری مطلق زیرجمعیت های سلولی لنفوسیت ها (B, T, NK) و نسبت آنها، اندازه گیری زیرجمعیت سلولهای تی (CD3+CD4+, CD3+CD8+)، اندازه گیری TNF-a و اینترلوکین های 4 و 5 و 2 و 17 و 6 و 12 و 17 آ و 17 اف و 21 و 8 و 10 .تکثیر سلولی با استفاده از روش CFSE. اندازه گیری اینترفرون گاما داخل سلولی (اینترلوکین 4 و TNF آلفا) در سلولهای CD4 و CD8 مواجهه یافته با آنتی ژن
اندازه گیری مطلق زیرجمعیت های سلولی لنفوسیت ها (B, T, NK) و نسبت آنها، اندازه گیری زیرجمعیت سلولهای تی (CD3+CD4+, CD3+CD8+)، اندازه گیری TNF-a و اینترلوکین های 4 و 5 و 2 و 17 و 6 و 12 و 17 آ و 17 اف و 21 و 8 و 10.
اندازه گیری مطلق زیرجمعیت های سلولی لنفوسیت ها (B, T, NK) و نسبت آنها، اندازه گیری زیرجمعیت سلولهای تی (CD3+CD4+, CD3+CD8+)، اندازه گیری TNF-a و اینترلوکین های 4 و 5 و 2 و 17 و 6 و 12 و 17 آ و 17 اف و 21 و 8 و 10.تکثیر سلولی با استفاده از روش CFSE. اندازه گیری اینترفرون گاما داخل سلولی (اینترلوکین 4 و TNF آلفا) در سلولهای CD4 و CD8 مواجهه یافته با آنتی ژن
Intervention groups
#1
Intervention group 1: Two times vaccines in the deltoid muscle (IM) with a dose of 0.5*10^6 (TCID50) equivalent to 5 μg/dose at 14-day intervals
Intervention group 1: Receiving two intramuscular doses of 0.5*10^6 (TCID50) strength of the vaccine equivalent to 5 μg/dose at a 14-days interval
Intervention group 1: Two times vaccines in the deltoid muscle (IM) with a doseReceiving two intramuscular doses of 0.5*10^6 (TCID50) strength of the vaccine equivalent to 5 μg/dose at a 14-day intervalsdays interval
#2
Intervention group 2: Two times vaccines in the deltoid muscle (IM) with a dose of 2.5*10^6 (TCID50) equivalent to 10 μg/dose at 14-day intervals
Intervention group 2: Receiving two intramuscular doses of 2.5*10^6 (TCID50) strength of the vaccine equivalent to 10 μg/dose at a 14-days interval
Intervention group 2: Two times vaccines in the deltoid muscle (IM) with a doseReceiving two intramuscular doses of 2.5*10^6 (TCID50) strength of the vaccine equivalent to 10 μg/dose at a 14-day intervalsdays interval
#3
Control group 1: Two times placebo in the deltoid muscle (IM) at 14-day intervals
Control group 1: Receiving two intramuscular doses of a placebo at a 14-days interval
Control group 1: Two timesReceiving two intramuscular doses of a placebo in the deltoid muscle (IM) at a 14-day intervalsdays interval
#4
Intervention group 3: Two times vaccines in the deltoid muscle (IM) with a dose of 0.5*10^6 (TCID50) equivalent to 5 μg/dose at 21-day intervals
Intervention group 3: Receiving two intramuscular doses of 0.5*10^6 (TCID50) strength of the vaccine equivalent to 5 μg/dose at a 21-days interval
Intervention group 3: Two times vaccines in the deltoid muscle (IM) with a doseReceiving two intramuscular doses of 0.5*10^6 (TCID50) strength of the vaccine equivalent to 5 μg/dose at a 21-day intervalsdays interval
#5
Intervention group 4: Two times vaccines in the deltoid muscle (IM) with a dose of 2.5*10^6 (TCID50) equivalent to 10 μg/dose at 21-day intervals
Intervention group 4: Receiving two intramuscular doses of 2.5*10^6 (TCID50) strength of the vaccine equivalent to 10 μg/dose at a 21-days interval
Intervention group 4: Two times vaccines in the deltoid muscle (IM) with a doseReceiving two intramuscular doses of 2.5*10^6 (TCID50) strength of the vaccine equivalent to 10 μg/dose at a 21-day intervalsdays interval
#6
Control group 2: Two times placebo in the deltoid muscle (IM) at 21-day intervals
Control group 2: Receiving two intramuscular doses of a placebo at a 21-days interval
Control group 2: Two timesReceiving two intramuscular doses of a placebo in the deltoid muscle (IM) at a 21-day intervalsdays interval
Recruitment centers
#1
Name of recruitment center - English: Fakhra clinical trial center
Name of recruitment center - Persian: مرکز کارآزمایی بالینی فخرا
Full name of responsible person - English: Mohsen Forughizadeh Moghadam
Full name of responsible person - Persian: محسن فروغی زاده مقدم
Street address - English: Fakhra clinical trial center,Persian Gulf Hall, Sased Sports Complex, Shahid Fakhrizadeh Street, Sayad Shirazi Highway, Tehran, Iran
Street address - Persian: شمال بزرگراه صیاد شیرازی، خیابان شهید فخری زاده روبروی بیمارستان چمران مجموعه ورزشی ساصد- مرکز کارآزمایی بالینی فخرا
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1986936911
Phone: +98 21 2610 1694
Fax:
Email: Foroughizadeh@modares.ac.ir
Web page address: http://www.fakhravac.ir
Name of recruitment center - English: Fakhra clinical trial center
Name of recruitment center - Persian: مرکز کارآزمایی بالینی فخرا
Full name of responsible person - English: Mohsen Forooghizade Moghadam
Full name of responsible person - Persian: محسن فروغی زاده مقدم
Street address - English: Fakhra clinical trial center, Persian Gulf Hall, Sased Sports Complex, Shahid Fakhrizadeh Street, Sayad Shirazi Highway, Tehran, Iran
Street address - Persian: شمال بزرگراه صیاد شیرازی، خیابان شهید فخری زاده روبروی بیمارستان چمران مجموعه ورزشی ساصد- مرکز کارآزمایی بالینی فخرا
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1986936911
Phone: +98 21 2610 1694
Fax:
Email: Foroughizadeh@modares.ac.ir
Web page address: http://www.fakhravac.ir
Name of recruitment center - English: Fakhra clinical trial center Name of recruitment center - Persian: مرکز کارآزمایی بالینی فخرا Full name of responsible person - English: Mohsen ForughizadehForooghizade Moghadam Full name of responsible person - Persian: محسن فروغی زاده مقدم Street address - English: Fakhra clinical trial center,Persiancenter, Persian Gulf Hall, Sased Sports Complex, Shahid Fakhrizadeh Street, Sayad Shirazi Highway, Tehran, Iran Street address - Persian: شمال بزرگراه صیاد شیرازی، خیابان شهید فخری زاده روبروی بیمارستان چمران مجموعه ورزشی ساصد- مرکز کارآزمایی بالینی فخرا City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1986936911 Phone: +98 21 2610 1694 Fax: Email: Foroughizadeh@modares.ac.ir Web page address: http://www.fakhravac.ir
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Malek Ashtar University
Name of organization / entity - Persian: دانشگاه مالک اشتر
Full name of responsible person - English: Mohsen ForughiZadeh Moghadam
Full name of responsible person - Persian: محسن فروغی زاده مقدم
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 51
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 12, Zomorod 1 block, Noor 1 St.,Shahid Mahalati Town
Street address - Persian: شهرک شهید محلاتی،خ نور 1،بلوک زمرد 1،واحد 12
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1955737134
Phone: +98 21 8008 6783
Mobile: +98 919 754 7955
Fax:
Email: Foroughizadeh@modares.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Malek Ashtar University
Name of organization / entity - Persian: دانشگاه مالک اشتر
Full name of responsible person - English: Mohsen Forooghizade Moghadam
Full name of responsible person - Persian: محسن فروغی زاده مقدم
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 51
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 12, Zomorod 1 block, Noor 1 St., Shahid Mahalati Town
Street address - Persian: شهرک شهید محلاتی، خ نور 1،بلوک زمرد 1،واحد 12
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1955737134
Phone: +98 21 8008 6783
Mobile: +98 919 754 7955
Fax:
Email: Foroughizadeh@modares.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Malek Ashtar University Name of organization / entity - Persian: دانشگاه مالک اشتر Full name of responsible person - English: Mohsen ForughiZadehForooghizade Moghadam Full name of responsible person - Persian: محسن فروغی زاده مقدم Position - English: Assistant professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 51 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No. 12, Zomorod 1 block, Noor 1 St.,ShahidSt., Shahid Mahalati Town Street address - Persian: شهرک شهید محلاتی،خ نور 1،بلوک زمرد 1،واحد 12 City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1955737134 Phone: +98 21 8008 6783 Mobile: +98 919 754 7955 Fax: Email: Foroughizadeh@modares.ac.ir Web page address:
Protocol summary
Study aim
Dose finding, safety and immunogenicity of Covid 19 FAKHRAVAC (MIVAC) inactivated vaccine in healthy population 18-55 years
Design
Randomized, double blind, controlled trial with parallel design on 135 volunteers. Fifteen sentinels without blinding and 120 in 5 groups of 24, double blind and randomized
Settings and conduct
Fakhra clinical trial center, Persian Gulf Hall, Sased Sports Complex, Shahid Fakhrizadeh Street, Sayad Shirazi Highway, Tehran, Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18-55 years; BMI 18-35; no abnormal clinical and laboratory findings; No current or previous infection with COVID-19; Use of safe methods of contraception; Signing informed consent form
Exclusion criteria: Current acute or chronic illness requiring regular medical or surgical attention; High-risk occupations exposed with Covid-19; serving in obligatory military service; Breastfeeding; Pregnancy
Intervention groups
Group1: vaccine strength of 0.5*10^6, two doses at 14-day intervals
Group2: vaccine strength of 2.5*10^6, two doses at 14-day intervals
Group3: placebo, two doses at 14-day intervals
Group4: vaccine strength of 0.5*10^6, two doses at 21-day intervals
Group5: vaccine strength of 2.5*10^6, two doses at 21-day intervals
Group6: placebo two doses at 21-day intervals
Main outcome variables
Primary outcomes: Reactogenicity (vital signs and anaphylactic reactions 3 hours post-vaccination; Local and systemic adverse events within the first-week post-vaccination; Abnormal laboratory findings one week after each dose.
Secondary outcomes: SAEs, SUSARs, MAAEs up to six months after the last dose of the vaccine; Occurrence of Covid-19 disease two weeks after the second dose of the vaccine onwards; Serum IgG level for SARS-CoV-2 to N and S antigens; Neutralizing antibody activity; Cell medicated immunity and safety of cell-mediated immune response.
General information
Reason for update
Correcting English translation
Acronym
IRCT registration information
IRCT registration number:IRCT20210206050259N1
Registration date:2021-03-08, 1399/12/18
Registration timing:prospective
Last update:2022-06-20, 1401/03/30
Update count:4
Registration date
2021-03-08, 1399/12/18
Registrant information
Name
Ahmad Karimi Rahjerdi
Name of organization / entity
Stem Cell Technology Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2208 2120
Email address
rahjerdi@strc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-10, 1399/12/20
Expected recruitment end date
2021-04-09, 1400/01/20
Actual recruitment start date
2021-03-16, 1399/12/26
Actual recruitment end date
2021-04-13, 1400/01/24
Trial completion date
2021-10-10, 1400/07/18
Scientific title
Phase 1, safety, immunogenicity and dose finding for two strengths of 0.5 × 10^6 and 2.5 × 10^6 (TCID50) inactivated SARS-CoV-2 vaccine FAKHRAVAC (MIVAC) injected in two schedules of two doses, 2 and 3 weeks apart in healthy adults aged 18-55 years: a randomized, double blind, placebo controlled, clinical trial
Public title
Safety, immunogenicity and dose finding for inactivated SARS-CoV-2 vaccine FAKHRAVAC (MIVAC)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian citizenship, and residing at a distance of 40-50 km from the study center
The ability of participants to study and understand informed consent, preferably educational level of high school and higher
Age between 18 and 55 years
Body mass index between 18 and 35 kg/m2
Being healthy based on clinical and laboratory examinations
Temperature less than or equal to 37.2°C sublingually measured by an electronic thermometer
Negative IgG and IgM antibody titers against COVID-19 N antigen
Negative RT-PCR test for COVID-19
Negative ELISA test for anti-HIV IgG
Heart rate between 60 and 100
Systolic blood pressure between 90 and 140 mm Hg, diastolic blood pressure between 60 and 90 mm Hg
Signing informed consent
Accepting commitments to reduce the risk of COVID-19 infection in daily life
Not pregnant
Negative β-hCG pregnancy test on the screening and vaccination days
The use of at least one safe method of contraception (condoms, oral contraceptive pills, IUD, Norplant capsule) for women of reproductive age 18 to 49 years
Willingness to continue using at least one safe method of contraception (condoms, oral contraceptive pills, IUD, Norplant capsule) for women of reproductive age 18 to 49 years up to three months after the second vaccine dose
Participants in the clinical trial should refrain from donating blood or plasma from the time of the first vaccine dose until three months after the second vaccine dose
should not participate in another trial during the study period
Expressing readiness to remain in the study for the entire study period
Married men should use safe methods of contraception up to three months after the second vaccine dose
Exclusion criteria:
Any acute or chronic symptomatic disease requiring ongoing medical or surgical care at the screening day
Healthcare workers
Breastfeeding
History of receiving any vaccine (whether investigational or non-investigational) within 30 days prior to the screening day
History of receiving other investigational drugs within 60 days prior to the screening day
History of receiving blood or any blood product or immunoglobulin within three months prior to the screening day
History of Immunodeficiency disorders (suspected or definite)
History of long-term use of immunosuppressive drugs (more than 14 consecutive days) within four months prior to the screening day
History of long-term use (more than 14 consecutive days) of systemic corticosteroids (equivalent to 10 mg or more daily prednisolone) or high-dose inhaled steroids (more than 800 µg/day of beclomethasone dipropionate or equivalent) within four months prior to the screening day (excluding topical steroids)
History of allergic diseases such as angioedema or anaphylaxis
History of any known allergy to drugs or vaccines including aluminum phosphate and albumin
History of known allergy to eggs
History of autoimmune diseases
Chemotherapy or radiotherapy in the last 5 years
History of cancer in the last 5 years
History of serious psychiatric illnesses
History of blood disorders (dyscrasia, coagulation disorders, platelet deficiency or disorder, deficiency of blood factors)
History of chronic obstructive pulmonary disease such as asthma diagnosed by a specialist
History of ischemic heart disease currently treated by a cardiologist or receiving any cardiac interventions
History of hypertension currently treated by a physician
History of diabetes currently treated by a physician
Congenital anomalies, growth retardation, genetic defects or severe malnutrition
Individual or family history of chronic neurological diseases (including seizures and epilepsy)
History of thyroid disease or Thyroidectomy
Any history of substance or alcohol abuse in the past 2 years
Abnormal hematological or biochemical test results at the time of screening
History of confirmed COVID-19
Acute febrile illness at the time of vaccination
History of allergy to acetaminophen
History of acute or chronic hepatitis B and C
History of pulmonary or extrapulmonary tuberculosis or receiving antituberculotic treatment
Receiving tuberculosis prophylaxis
History of faint in any encounter with needles or phlebectomy
Splenectomy for any reason or history of abnormal spleen function
Any close contact with a confirmed COVID-19 case up to two weeks before receiving the first vaccine dose
Previous history of diseases such as SARS and MERS
Not fit to participate in the trial (the decision is at the discretion of the chief investigator)
People who are currently serving their obligatory military service in the Armed Forces
Age
From 18 years old to 55 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
135
Actual sample size reached:
135
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the Block Randomization method with different block sizes was used to assign each participant to the intervention groups. The rand() function of Excel software will be used to generate a random sequence within each block. After determining the allocated intervention, each participant was assigned a non-repetitive four-digit random code. Assigned codes will be delivered to the eligible participants via study software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, a placebo will be used. Adjuvant-only IMP will be used as a placebo. All people involved in the study will be blind to the type of IMP received except the epidemiologist responsible for unblinding. In cases of any serious adverse event or any trend in the occurrence of adverse events towards one of the groups, unblinding will occur by DSMB request. On other clinical occasions, unblinding could occur with the principal investigators' approval.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Research Ethics committee
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
7334144696
Approval date
2021-02-28, 1399/12/10
Ethics committee reference number
IR.NREC.1399.006
Health conditions studied
1
Description of health condition studied
SARS-CoV-2
ICD-10 code
U07.1 COVI
ICD-10 code description
U07.1 COVID-19, virus identified
Primary outcomes
1
Description
Abnormal vital signs and anaphylactic reactions immediately after vaccination. Vital signs include body temperature, Respiratory rate, heart rate, systolic and diastolic blood pressure before and immediately after vaccination.
Timepoint
In the first three hours after each vaccination
Method of measurement
Sublingual temperature is measured using a digital thermometer. Heart rate and respiratory rate will be counted by the research staff in one minute. Blood pressure will be measured using a digital sphygmomanometer in sitting position.
2
Description
Local adverse events within the first week post-vaccination including pain, tenderness, erythema and redness, and swelling and stiffness
Timepoint
In the first seven days after each vaccine dose
Method of measurement
Daily telephone contacts by the research team for seven days
3
Description
Systemic adverse event within the first week post-vaccination including nausea and vomiting, diarrhea, headache, fatigue, muscle pain, and other illnesses or clinical complications
Timepoint
In the first seven days after each vaccine dose and then monthly for up to six months
Up to six months after the last dose of the vaccine
Method of measurement
Monthly follow-up by the research team
2
Description
Occurrence of Covid-19 disease
Timepoint
Two weeks after the second dose of the vaccine
Method of measurement
PCR test
3
Description
Serum IgG level for SARS-CoV-2 N and S antigens
Timepoint
In the vaccination schedule 0-14: on days zero, 7, 14, 28, 42, 72 and months 3, 6. In the vaccination schedule 0-21: on days zero, 7, 14, 21, 35, 49 and months 3, 6.
Method of measurement
ELISA method
4
Description
Neutralizing antibody activity
Timepoint
In the vaccination schedule 0-14: on days zero, 14, 28, 42 and months 3, 6. In the vaccination schedule 0-21: on days zero, 21, 35, 49 and months 3, 6.
Method of measurement
Conventional SARS-CoV-2 virus neutralizing antibody test
5
Description
Cell-mediated immunity and safety of the immune response
Timepoint
In the vaccination schedule 0-14: on days zero, 14, 28, 42 and months 3, 6. In the vaccination schedule 0-21: on days zero, 21, 35, 49 and months 3, 6. This outcome will be measured on day zero and two weeks after the second injection for all volunteers and at other time points for 20% of the participants.
Method of measurement
Absolute measurement of lymphocyte cell subpopulations (B, T, NK) and their ratio, measurement of T cell subpopulations (CD3 + CD4 +, CD3 + CD8 +), measurement of TNF-a and interleukins 4, 5, 2, 17, 6, 12, 17A, 17F, 21, 8 and 10.
Intervention groups
1
Description
Intervention group 1: Receiving two intramuscular doses of 0.5*10^6 (TCID50) strength of the vaccine equivalent to 5 μg/dose at a 14-days interval
Category
Prevention
2
Description
Intervention group 2: Receiving two intramuscular doses of 2.5*10^6 (TCID50) strength of the vaccine equivalent to 10 μg/dose at a 14-days interval
Category
Prevention
3
Description
Control group 1: Receiving two intramuscular doses of a placebo at a 14-days interval
Category
Placebo
4
Description
Intervention group 3: Receiving two intramuscular doses of 0.5*10^6 (TCID50) strength of the vaccine equivalent to 5 μg/dose at a 21-days interval
Category
Prevention
5
Description
Intervention group 4: Receiving two intramuscular doses of 2.5*10^6 (TCID50) strength of the vaccine equivalent to 10 μg/dose at a 21-days interval
Category
Prevention
6
Description
Control group 2: Receiving two intramuscular doses of a placebo at a 21-days interval
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fakhra clinical trial center
Full name of responsible person
Mohsen Forooghizade Moghadam
Street address
Fakhra clinical trial center, Persian Gulf Hall, Sased Sports Complex, Shahid Fakhrizadeh Street, Sayad Shirazi Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1986936911
Phone
+98 21 2610 1694
Email
Foroughizadeh@modares.ac.ir
Web page address
http://www.fakhravac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Organization of Defensive Innovation and Research
Full name of responsible person
Ahmad Karimi Rahjerdi
Street address
NO.9, Unit 3, Mirsharifi, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1986936911
Phone
+98 21 2265 8405
Fax
+98 21 2265 8404
Email
Rahjerdi@strc.ac.ir
Web page address
http://miladpharmaceuticsco.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Organization of Defensive Innovation and Research
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Malek Ashtar University
Full name of responsible person
Mohsen Forooghizade Moghadam
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
No. 12, Zomorod 1 block, Noor 1 St., Shahid Mahalati Town
City
Tehran
Province
Tehran
Postal code
1955737134
Phone
+98 21 8008 6783
Email
Foroughizadeh@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Ramin Hamidi Farahani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
NO.9, Unit 3, Mirsharifi, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1986936911
Phone
+98 21 8833 7912
Email
Rgsramin@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Milad Daro Noor Pharmaceutical Co.
Full name of responsible person
Kosar Naderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biology
Street address
NO.9, Unit 3, Mirsharifi, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1986936911
Phone
+98 21 2265 8405
Email
k.naderi@strc.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Deidentified IPD on study outcomes could be shared.
When the data will become available and for how long
After completion of the study and publication of the results, data could be shared for 2 years
To whom data/document is available
Data is available only to members of academic institutions within joint projects with MILAD Daru Nour Co.
Under which criteria data/document could be used
Proposal should be presented to MILAD Daru Nour Co and its necessity and scientific validity should be approved by the company
From where data/document is obtainable
You can contact Ms Kousar Naderi at k.naderi@strc.ac.ir
What processes are involved for a request to access data/document
Request for data will be made available within the approved joint projects