1. Home
  2. Approved trials
  3. » فارسی

Immunogenicity and Safety of intranasal Razi Cov Pars as a booster dose in adult population; randomised, double blind, placebo controlled clinical trial

View the latest revision

History
# Registration date Revision Id
3 2024-01-21, 1402/11/01 292213
2 2023-12-27, 1402/10/06 289778
1 2022-11-29, 1401/09/08 247349
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • General information

    empty
    193
    empty
    2023-01-03, 1401/10/13
    empty
    2023-02-22, 1401/12/03
    empty
    2023-04-08, 1402/01/19
    empty
    reporting actual start and end dates and completion date, amending inclusion criteria
    empty
    گزارش تاریخ شروع و پایان واقعی و تاریخ تکمیل مطالعه، اصلاح معیارهای ورود
    Having Iranian citizenship or in the case of foreign nationals with a legal residence permit
    Age 18 years and older
    History of full vaccination with one of the following vaccines: Sinopharm, Razi Cov Pars, Pastocovac, Spikogen, AstraZeneca, Fakhra, or Barkat at least 5 months before the study
    Minimum 5 and maximum 9 months interval between the last vaccine dose and the current study participation
    In the last six months, the person has not had a confirmed Covid-19 disease based on laboratory evidence or confirmed by a physician
    Signing a written informed consent form
    Using at least one reliable contraceptive method (condom, oral contraceptive pills, intrauterine contraceptive device, IUD, Norplant capsule) for women of reproductive age 18 to 49 years until 3 months after receiving the booster dose
    Negative pregnancy test (baby check) on the day of vaccination
    Having Iranian citizenship or in the case of foreign nationals with a legal residence permit
    Age 18 years and older
    History of full vaccination with one of the following vaccines: Sinopharm, Razi Cov Pars, Pastocovac, Spikogen, AstraZeneca, Fakhra, or Barkat at least 5 months before the study
    5 months interval between the last vaccine dose and the current study participation
    In the last six months, the person has not had a confirmed Covid-19 disease based on laboratory evidence or confirmed by a physician
    Signing a written informed consent form
    Using at least one reliable contraceptive method (condom, oral contraceptive pills, intrauterine contraceptive device, IUD, Norplant capsule) for women of reproductive age 18 to 49 years until 3 months after receiving the booster dose
    Negative pregnancy test (baby check) on the day of vaccination
    داشتن تابعیت ایرانی ویا درمورد اتباع خارجی دارای مجوز قانونی اقامت
    سن ۱8 سال و بالاتر
    سابقه واکسیناسیون کامل بر اساس آخرین دوز واکسن دریافتی در پنج ماه قبل با یکی از واکسنهای سینوفارم ، رازی کووپارس ، پاستوکوک ، اسپایکوژن ، آسترازنکا ، فخرا، و برکت
    پنج تا نه ماه از آخرین دوز واکسن قبلی گذشته باشد
    در شش ماه گذشته بیماری کرونای تایید شده بر اساس شواهد آزمایشگاهی یا تائید توسط پزشک نداشته باشد
    امضای فرم رضایت نامه آگاهانه
    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 دریافت دوز بوستر
    تست منفی بارداری (baby check ) در روز واکسیناسیون
    داشتن تابعیت ایرانی ویا درمورد اتباع خارجی دارای مجوز قانونی اقامت
    سن ۱8 سال و بالاتر
    سابقه واکسیناسیون کامل بر اساس آخرین دوز واکسن دریافتی در پنج ماه قبل با یکی از واکسنهای سینوفارم ، رازی کووپارس ، پاستوکوک ، اسپایکوژن ، آسترازنکا ، فخرا، و برکت
    پنج ماه از آخرین دوز واکسن قبلی گذشته باشد
    در شش ماه گذشته بیماری کرونای تایید شده بر اساس شواهد آزمایشگاهی یا تائید توسط پزشک نداشته باشد
    امضای فرم رضایت نامه آگاهانه
    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 دریافت دوز بوستر
    تست منفی بارداری (baby check ) در روز واکسیناسیون
    سابقه هر نوع حساسیت به دارو یا واکسن ویا بروز حساسیت بعد ازدریافت واکسنهای قبلی کووید ( شامل کهیر و تب)
    داشتن ( در زمان مراجعه) هر نوع بیماری علامت دار حاد یا مزمن که نیازمند مراقبت مداوم داخلی یا جراحی از یک ماه گذشته تا کنون
    سابقه ابتلا به بیماریهای قلبی و عروقی شدید (نارسایی قلبی، سابقه بستری به علت بیماری قلبی) در یکسال گذشته
    بارداری بر اساس اظهار شرکت کننده و زمان اولین روز آخرین قاعدگی (Last Menstural Period )
    شیردهی
    سابقه ی دریافت هرگونه واکسن ( تحقیقاتی و یا غیرتحقیقاتی ) در طی ۱۴ روز قبل از روز دریافت دوز بوستر داخل بینی
    سابقه ی دریافت خون و یا هرنوع فرآورده ی خونی و یا ایمنوگلوبولین در ظرف 3 ماه قبل از روز دریافت دوز بوستر داخل بینی
    ابتلا به بیماریهای کاهش دهنده ی سیستم ایمنی ( مشکوک و قطعی) - سابقه ی مصرف طولانی مدت داروهای کاهنده ی سیستم ایمنی از جمله سابقه ی مصرف طولانی مدت کورتیکواستروئید های سیستمیک ( معادل۱۰ میلی گرم یا بیشتر روزانه پردنیزولون ) ( به استثنای مصرف استروئیدهای موضعی ) ( بیش از ۱۴ روز پشت سرهم ) در ۴ ماه اخیر منتهی به روز غربالگری
    تشخیص یا درمان اخیر سرطان ها بجز basal cell carcinoma وinsitu cervical cancer
    سابقه ی ابتلا به بیماری های جدی روانپزشکی کنترل نشده
    سابقه ی ابتلا به اختلالات خونی ( دیسکرازی، انعقادی، کمبود یا اختلال پلاکت، کمبود فاکتورهای خونی )
    سابقه ابتلا به بیماریهای نورولوژیک مزمن ( از جمله تشنج و صرع)
    سوء مصرف ( اعتیاد) فعلی به مواد و یا الکل
    ابتلا به بیماری حاد تب دار در زمان دریافت دوز بوستر واکسن
    فردی که به هرعلت اسپلنکتومی شده است
    هرگونه تماس نزدیک با فرد مبتلای قطعی به کووید-۱9 در مدت حداکثر دو هفته قبل از شرکت در مطالعه
    استفاده مداوم از داروهای ضد انعقاد خون مانند کومارین ها و داروهای ضد انعقاد خون مرتبط ( مانند وارفارین ) یا داروهای ضد انعقاد خوراکی/عوامل ضد پلاکت جدید. توجه : مصرف کمتر از 325 میلی گرم آسپرین در روز به عنوان پروفیلاکسی مجاز است
    ابتلا به بیماری های مزمن که در سایر بندها به عنوان معیارهای خروج از مطالعه در نظر گرفته نشده اند ولی توسط محقق اصلی به عنوان بیماری ناپایدار در ۴ هفته اخیر در نظر گرفته شود. مشخصه های بیماری ناپایدار: بستری در بیمارستان به علت جراحی ، وخامت عملکرد یکی از اعضاء بدن ، نیاز به افزودن داروهای جدید یا تعدیل دوز جدی در داروهای فعلی
    سابقه هر نوع حساسیت به دارو یا واکسن ویا بروز حساسیت بعد ازدریافت واکسنهای قبلی کووید ( شامل کهیر و تب)
    داشتن ( در زمان مراجعه) هر نوع بیماری علامت دار حاد یا مزمن که نیازمند مراقبت مداوم داخلی یا جراحی از یک ماه گذشته تا کنون
    سابقه ابتلا به بیماریهای قلبی و عروقی شدید (نارسایی قلبی، سابقه بستری به علت بیماری قلبی) در یکسال گذشته
    بارداری بر اساس اظهار شرکت کننده و زمان اولین روز آخرین قاعدگی (Last Menstural Period )
    شیردهی
    سابقه ی دریافت هرگونه واکسن ( تحقیقاتی و یا غیرتحقیقاتی ) در طی ۱۴ روز قبل از روز دریافت دوز بوستر داخل بینی
    سابقه ی دریافت خون و یا هرنوع فرآورده ی خونی و یا ایمنوگلوبولین در ظرف 3 ماه قبل از روز دریافت دوز بوستر داخل بینی
    ابتلا به بیماریهای کاهش دهنده ی سیستم ایمنی ( مشکوک و قطعی) - سابقه ی مصرف طولانی مدت داروهای کاهنده ی سیستم ایمنی از جمله سابقه ی مصرف طولانی مدت کورتیکواستروئید های سیستمیک (معادل۱۰ میلی گرم یا بیشتر روزانه پردنیزولون) (به استثنای مصرف استروئیدهای موضعی) (بیش از ۱۴ روز پشت سرهم) در ۴ ماه اخیر منتهی به روز غربالگری
    تشخیص یا درمان اخیر سرطان ها بجز basal cell carcinoma وinsitu cervical cancer
    سابقه ی ابتلا به بیماری های جدی روانپزشکی کنترل نشده
    سابقه ی ابتلا به اختلالات خونی (دیسکرازی، انعقادی، کمبود یا اختلال پلاکت، کمبود فاکتورهای خونی)
    سابقه ابتلا به بیماریهای نورولوژیک مزمن ( از جمله تشنج و صرع)
    سوء مصرف (اعتیاد) فعلی به مواد و یا الکل
    ابتلا به بیماری حاد تب دار در زمان دریافت دوز بوستر واکسن
    فردی که به هرعلت اسپلنکتومی شده است
    هرگونه تماس نزدیک با فرد مبتلای قطعی به کووید-۱9 در مدت حداکثر دو هفته قبل از شرکت در مطالعه
    استفاده مداوم از داروهای ضد انعقاد خون مانند کومارین ها و داروهای ضد انعقاد خون مرتبط (مانند وارفارین) یا داروهای ضد انعقاد خوراکی/عوامل ضد پلاکت جدید. توجه : مصرف کمتر از 325 میلی گرم آسپرین در روز به عنوان پروفیلاکسی مجاز است
    ابتلا به بیماری های مزمن که در سایر بندها به عنوان معیارهای خروج از مطالعه در نظر گرفته نشده اند ولی توسط محقق اصلی به عنوان بیماری ناپایدار در ۴ هفته اخیر در نظر گرفته شود. مشخصه های بیماری ناپایدار: بستری در بیمارستان به علت جراحی ، وخامت عملکرد یکی از اعضاء بدن، نیاز به افزودن داروهای جدید یا تعدیل دوز جدی در داروهای فعلی

  • Primary outcomes

    #1
    two weeks after the intranasal booster dose
    2 weeks after the intranasal booster dose

  • Secondary outcomes

    #1
    two weeks after the intranasal booster dose
    2 weeks after the intranasal booster dose
    #2
    two weeks after the intranasal booster dose
    2 weeks after the intranasal booster dose
    #3
    تعداد و درصد واکنش ناخواسته سیستمیک در هفته اول بعد از دریافت واکسن (شامل تهوع و استفراغ، اسهال ، سردرد ، خستگی ، درد عضلانی) که بر اساس نمره وخامت عارضه، طول دوره و حداکثر شدت ارزیابی خواهند شد.
    تعداد و درصد واکنش ناخواسته سیستمیک در هفته اول بعد از دریافت واکسن (شامل تهوع و استفراغ، اسهال، سردرد، خستگی، درد عضلانی) که بر اساس نمره وخامت عارضه، طول دوره و حداکثر شدت ارزیابی خواهند شد.

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Razi Vaccine and Serum Research Institute
    Name of organization / entity - Persian: موسسه تحقیقات واکسن و سرم سازی رازی
    Full name of responsible person - English: Mohammad Hossein Fallah Mehrabadi
    Full name of responsible person - Persian: محمد حسین فلاح مهرآبادی
    Position - English: Faculty member
    Position - Persian: عضو هیئت علمی
    Latest degree: phd
    Area of specialty/work: 2
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Hesarak - Shahid Beheshti street- Karaj
    Street address - Persian: کرج - خیابان شهید بهشتی - حصارک
    City - English: Karaj
    City - Persian: کرج
    Province: Alborz
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3197619751
    Phone: +98 26 3457 0038
    Mobile: +98 913 352 0552
    Fax:
    Email: mhf2480@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Razi Vaccine and Serum Research Institute
    Name of organization / entity - Persian: موسسه تحقیقات واکسن و سرم سازی رازی
    Full name of responsible person - English: Mohammad Hossein Fallah Mehrabadi
    Full name of responsible person - Persian: محمد حسین فلاح مهرآبادی
    Position - English: Faculty member
    Position - Persian: عضو هیئت علمی
    Latest degree: phd
    Area of specialty/work: 2
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Hesarak, Shahid Beheshti Street, Karaj
    Street address - Persian: کرج، خیابان شهید بهشتی، حصارک
    City - English: Karaj
    City - Persian: کرج
    Province: Alborz
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3197619751
    Phone: +98 26 3457 0038
    Mobile: +98 913 352 0552
    Fax:
    Email: mhf2480@yahoo.com
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Iran University of Medical Sciences
    Full name of responsible person - Persian: سعید کلانتری
    Position - English: Associate Professor
    Position - Persian: دانشیار
    Latest degree: specialist
    Area of specialty/work:
    Area of specialty/work title - English: Infectious diseases
    Area of specialty/work title - Persian: عفونی
    Street address - English: Corner of Mansouri, Niayesh, Satarkhan Av, Tehran
    Street address - Persian: ستارخان - خ. نیایش - نبش خیابان منصوری - بیمارستان حضرت رسول اکرم (ص)
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۱۴۴۵۶۱۳۱۳۱
    Phone: +98 21 6435 1000
    Mobile: +98 21 6435 1000
    Fax:
    Email: kalantari.s@iums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Iran University of Medical Sciences
    Full name of responsible person - Persian: سعید کلانتری
    Position - English: Associate Professor
    Position - Persian: دانشیار
    Latest degree: specialist
    Area of specialty/work:
    Area of specialty/work title - English: Infectious diseases
    Area of specialty/work title - Persian: عفونی
    Street address - English: Corner of Mansouri, Niayesh, Satarkhan Av, Tehran
    Street address - Persian: ستارخان، خ. نیایش، نبش خیابان منصوری، بیمارستان حضرت رسول اکرم (ص)
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۱۴۴۵۶۱۳۱۳۱
    Phone: +98 21 6435 1000
    Mobile: +98 21 6435 1000
    Fax:
    Email: kalantari.s@iums.ac.ir
    Web page address:

Protocol summary

Study aim
Immunogenicity and Safety of intranasal Razi Cov Pars as a booster dose in adult population
Design
This is a randomized double blind placebo controlled parallel group clinical trial. In this study we explore the immunogenicity of intranasal Razi Cov Pars as a booster dose. Stratified block randomization will be used. The type of the vaccine in the primary vaccination will be used to define the strata. An adjuvant only preparation will be used as placebo.
Settings and conduct
Razi Vaccine and Serum Research Institute Beheshti Ave, Hesarak, Karaj, Alborz Province
Participants/Inclusion and exclusion criteria
Main inclusion criteria: Age 18 years and older, Minimum 5 and maximum 9 months interval from the last vaccine dose, no history of confirmed Covid-19 illness during the first 5 months. Major exclusion criteria: History of allergic reactions after receiving any previous Covid-19 vaccines or any other drug or vaccine, Having any acute or chronic illness requiring continuous ongoing medical or surgical care within the last month
Intervention groups
Intervention group: One intranasal dose of 10 microgram per 200 micro liter of Razi Cov Pars recombinant protein vaccine; Control group: One intranasal dose of placebo
Main outcome variables
Serum levels of specific IgG antibodies against S and RBD antigens two weeks after the intranasal booster dose by ELISA method, Serum levels of specific IgA antibodies against RBD antigen, levels of specific IgG/IgA antibodies against S and RBD in saliva and nasal mucosa, Abnormal vital signs and anaphylactic reactions before and immediately after vaccination; The number and percentage of systemic adverse reactions within the first week post-vaccination, Number and percentage of Severe Adverse events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSAR ) and Medically Attended Adverse Events (MAAEs) Up to one month after receiving the booster dose.

General information

Reason for update
reporting actual start and end dates and completion date, amending inclusion criteria
Acronym
IRCT registration information
IRCT registration number: IRCT20201214049709N6
Registration date: 2022-11-29, 1401/09/08
Registration timing: prospective

Last update: 2024-01-22, 1402/11/02
Update count: 2
Registration date
2022-11-29, 1401/09/08
Registrant information
Name
Ali Eshaghi
Name of organization / entity
Razi Vaccine and Serum Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 26 3457 0038
Email address
a.eshaghi@rvsri.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-03, 1401/09/12
Expected recruitment end date
2023-02-27, 1401/12/08
Actual recruitment start date
2023-01-03, 1401/10/13
Actual recruitment end date
2023-02-22, 1401/12/03
Trial completion date
2023-04-08, 1402/01/19
Scientific title
Immunogenicity and Safety of intranasal Razi Cov Pars as a booster dose in adult population; randomised, double blind, placebo controlled clinical trial
Public title
Immunogenicity and Safety of intranasal Razi Cov Pars as a booster dose
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having Iranian citizenship or in the case of foreign nationals with a legal residence permit Age 18 years and older History of full vaccination with one of the following vaccines: Sinopharm, Razi Cov Pars, Pastocovac, Spikogen, AstraZeneca, Fakhra, or Barkat at least 5 months before the study 5 months interval between the last vaccine dose and the current study participation In the last six months, the person has not had a confirmed Covid-19 disease based on laboratory evidence or confirmed by a physician Signing a written informed consent form Using at least one reliable contraceptive method (condom, oral contraceptive pills, intrauterine contraceptive device, IUD, Norplant capsule) for women of reproductive age 18 to 49 years until 3 months after receiving the booster dose Negative pregnancy test (baby check) on the day of vaccination
Exclusion criteria:
History of allergic reactions after receiving any previous Covid-19 vaccines or any other drug or vaccine Having any acute or chronic illness requiring continuous ongoing medical or surgical care within the last months History of severe cardiovascular disease such as heart failure, or hospitalization due to heart disease within the last year Pregnancy declared by the participant based on the first day of the last menstrual period (LMP) Breastfeeding History of receiving any vaccine within 14 days of receiving the intranasal booster dose Received blood and/or any blood products and/or immunoglobulins within three months prior to the intranasal booster dose Diagnosed (suspected or confirmed) with immunocompromising illneses, history of long-term use of immunosuppressive drugs, including history of long-term use of systemic corticosteroids equivalent to 10 mg or more daily prednisolone for more than 14 consecutive days with the exception of topical steroids within the last 4 months Recent diagnosis or treatment of cancers except basal cell carcinoma and In-situ cervical cancer History of uncontrolled serious psychiatric illnesses History of blood disorders (dyscrasia, coagulopathy, platelet deficiency or disorder, or deficiency of blood clotting factors) History of chronic neurological diseases (including seizures and epilepsy) Current substance or alcohol abuse Acute febrile illness at the time of receiving the booster dose Splenectomy for any reason Close contact with a confirmed COVID-19 case within two weeks before participating in the current study Continued use of anticoagulants such as coumarin and related anticoagulants (such as warfarin) or new oral anticoagulants / antiplatelet agents. Note: Less than 325 mg of aspirin per day as prophylaxis is allowed Chronic unstable diseases in the last 4 weeks, including hospitalization due to surgery, deterioration of one of the organ system's function, a need to add new drugs or serious dose adjustments for existing drugs
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 206
Actual sample size reached: 193
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, stratified block randomization method with variable block sizes of 4 and 6 were used to assign each participant to the intervention groups. The rand() function of Excel software were used to generate the random sequence within each block. After determining the allocated intervention, a non-repetitive eight-digit random code was assigned to each participant.This random code is a compilation of strata number, the number assigned to each participant and the "RIB" character and study participants will be identified by these codes during the study. Each strata includes participants that have received one of the seven vaccines (Sinopharm, Razi Cov Pars, Pastocovac, Spikogen, AstraZeneca, Fakhra, or Barkat) used as part of Iranian National Vaccination program as their primary vaccination.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, blinding will be achieved by using placebo which is the adjuvant only preparation identical in volume, appearance and packaging to the vaccine and will be used intranasally the same as the vaccine. In this study participants and all the research team members are unaware of the type of intervention. The study epidemiologist will keep the key to the random codes and will unblind any particular participant or participants if necessary.
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
2022-11-26, 1401/09/05
Ethics committee reference number
IR.NREC.1401.004

Health conditions studied

1

Description of health condition studied
SARS-CoV-2
ICD-10 code
COVID-19
ICD-10 code description
U07.1

Primary outcomes

1

Description
Serum levels of specific IgG antibodies against S and RBD antigens
Timepoint
2 weeks after the intranasal booster dose
Method of measurement
ELISA method

Secondary outcomes

1

Description
Serum levels of specific IgA antibody against RBD antigen
Timepoint
2 weeks after the intranasal booster dose
Method of measurement
ELISA method

2

Description
levels of specific IgG and IgA antibodies against S and RBD antigens in saliva and nasal mucosa.
Timepoint
2 weeks after the intranasal booster dose
Method of measurement
ELISA method

3

Description
Abnormal vital signs and anaphylactic reactions before and immediately after vaccination: number and percentages of participants who develop abnormal vital signs within half an hour of receiving the vaccine will be recorded. Abnormal vital signs include temperature, respiratory rate, heart rate, systolic and diastolic blood pressure. Anaphylaxis is defined as an immediate systemic hypersensitivity simultaneously involving two systems. Anaphylactic reactions include: erythema, pruritus, urticaria and angioedema, bronchospasm, laryngeal edema, dizziness, hypotension, nausea, shortness of breath, wheezing, arrhythmia, cyanosis, vomiting, diarrhea, abdominal pain and will be checked up to half an hour after vaccine booster dose.
Timepoint
Before vaccination and half an hour after vaccination
Method of measurement
Clinical examination

4

Description
The number and percentage of systemic adverse reactions within the first week post-vaccination (including pain, tenderness, erythema / redness, swelling and stiffness, itching) that will be assessed based on the severity score, duration and peak intensity.
Timepoint
Daily, within the first week after intranasal booster dose
Method of measurement
Via mobile application, study staff will contact participants who fail to fill their application and complete a local adverse reaction form on their behalf.

5

Description
Number and percentage of Severe Adverse events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSAR ) and Medically Attended Adverse Events (MAAEs) Up to one month after receiving the booster dose.
Timepoint
Up to one month after the intranasal booster dose
Method of measurement
Active follow-up on a weekly basis will be done by phone. Report of an adverse event could also be made via the mobile application. There will be a physician available 24/7 in the follow up center and all the reported events will be recorded and followed up by the staff in the center.

Intervention groups

1

Description
Intervention group: One intransal dose of 10 microgram per 200 microliter of Razi Cov Pars recombinant protein vaccine
Category
Prevention

2

Description
Control group: One intransal dose of placebo
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Vaccine and Serum Research Institute
Full name of responsible person
Ladan Mokhberossafa
Street address
Hesarak, Beheshti Ave
City
Karaj
Province
Alborz
Postal code
3197619751
Phone
+98 26 3457 0038
Email
lady.Katbi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi Vaccine and Serum Research Institute
Full name of responsible person
Ali Eshaghi
Street address
Beheshti Ave, Hesarak, Karaj, Alborz Province
City
Karaj
Province
Alborz
Postal code
3197619751
Phone
+98 26 3457 0038
Email
a.Eshahghi@rvsri.ac.ir
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi Vaccine and Serum Research Institute
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Razi Vaccine and Serum Research Institute
Full name of responsible person
Mohammad Hossein Fallah Mehrabadi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Hesarak, Shahid Beheshti Street, Karaj
City
Karaj
Province
Alborz
Postal code
3197619751
Phone
+98 26 3457 0038
Email
mhf2480@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Iran University of Medical Sciences
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Corner of Mansouri, Niayesh, Satarkhan Av, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6435 1000
Email
kalantari.s@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Razi Vaccine and Serum Research Institute
Full name of responsible person
Ladan Mokhberossaf
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Beheshti Ave, Hesarak, Karaj, Alborz Province
City
Karaj
Province
Alborz
Postal code
3197619751
Phone
00982634570038-46
Fax
Email
lady.Katbi@yahoo.com
Web page address

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 related to outcome will be shared
When the data will become available and for how long
The access period will begin once the study is complete and the main results have been published in peer reviewed journals.
To whom data/document is available
The data that have been published in peer reviewed journals, will be available just for academic researchers.
Under which criteria data/document could be used
The proposed study protocol should be submitted to RAZI vaccine and serum research institute and approved by its scientific and technical committee.
From where data/document is obtainable
After publishing the article researchers can submit their request to Dr. Mohammad Hossein Fallah at the following email address (mhf2480@yahoo.com ).
What processes are involved for a request to access data/document
Data will be made availabe after consideration and approval by the relevant authorities from Razi Vaccine and Serum Research Institute.
Comments
Loading...