Immunogenicity and safety evaluation of Pastocovac Plus as the booster dose in Iranian adults aged from 18 to 80 who received two doses of Sinopharm and Astrazeneca
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Primary outcomes
#1
Quadruple the Anti-Spike headline
Increased Anti-Spike headline
Quadruple theIncreased Anti-Spike headline
افزایش چهار برابری تیتر Anti-Spike
افزایش تیتر Anti-Spike
افزایش چهار برابری تیتر Anti-Spike
#2
empty
Quadrupling the neutralizing antibody titer
Quadrupling the neutralizing antibody titer
empty
افزایش چهار برابری تیتر آنتی بادی خنثی کننده
افزایش چهار برابری تیتر آنتی بادی خنثی کننده
empty
At the beginning of the study (before the intervention) and one month after the intervention (receiving a booster dose)
At the beginning of the study (before the intervention) and one month after the intervention (receiving a booster dose)
empty
در ابتدای مطالعه ( قبل از شروع مداخله) و یک ماه پس از مداخله ( دریافت دوز بوستر)
در ابتدای مطالعه ( قبل از شروع مداخله) و یک ماه پس از مداخله ( دریافت دوز بوستر)
empty
SARS-CoV-2 Neutralizing Ab Elisa kit
SARS-CoV-2 Neutralizing Ab Elisa kit
empty
کیت سنجش آنتی بادی خنثی کننده SARS-CoV-2 به روش الایزا
کیت سنجش آنتی بادی خنثی کننده SARS-CoV-2 به روش الایزا
Secondary outcomes
#1
Quadrupling the neutralizing antibody titer
Evaluating safety of Booster dose
Quadrupling the neutralizing antibody titerEvaluating safety of Booster dose
افزایش چهار برابری تیتر آنتی بادی خنثی کننده
تعیین بی خطری دوز بوستر
افزایش چهار برابری تیتر آنتی بادی خنثی کنندهتعیین بی خطری دوز بوستر
At the beginning of the study (before the intervention) and one month after the intervention (receiving a booster dose)
During 30 mins till one month after intervention
At the beginning of the study (before the intervention) andDuring 30 mins till one month after the intervention (receiving a booster dose)
در ابتدای مطالعه ( قبل از شروع مداخله) و یک ماه پس از مداخله ( دریافت دوز بوستر)
در طی نیم ساعت بعد از مداخله تا یک ماه بعد از مداخله
در ابتدای مطالعه ( قبلطی نیم ساعت بعد از شروع مداخله) و تا یک ماه پسبعد از مداخله ( دریافت دوز بوستر)
Antibody Assay Anti-Neutralizing-Ab
Visiting cases(days 0,30) and follow up cases every two weeks by phone call.
Antibody Assay Anti-Neutralizing-AbVisiting cases(days 0,30) and follow up cases every two weeks by phone call.
سنجش آنتی بادی Anti-Neutralizing-Ab
با ویزیت های حضوری ( روز صفر و 30) و پیگیری تلفنی هر دو هفته در این فاصله
سنجش آنتی بادی Anti-Neutralizing-Abبا ویزیت های حضوری ( روز صفر و 30) و پیگیری تلفنی هر دو هفته در این فاصله
Recruitment centers
#1
Name of recruitment center - English: Vaccination Department of Pasteur Institute of Iran
Name of recruitment center - Persian: بخش واکسیناسیون انستیتو پاستور ایران
Full name of responsible person - English: Dr. sarah Dahmardeh
Full name of responsible person - Persian: دکتر سارا دهمرده
Street address - English: No.69/ Pasteur Ave.13164
Street address - Persian: خیابان پاستور پلاک 69 انستیتو پاستور ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1316943551
Phone: +98 21 6695 3311
Fax: +98 21 6646 5132
Email: sarahdahmardeh@gmail.com
Web page address:
Name of recruitment center - English: Vaccination Department of Pasteur Institute of Iran
Name of recruitment center - Persian: بخش واکسیناسیون انستیتو پاستور ایران
Full name of responsible person - English: Dr. sarah Dahmardeh
Full name of responsible person - Persian: دکتر سارا دهمرده
Street address - English: No. 69, Pasteur Ave., Tehran , Iran
Street address - Persian: خیابان پاستور پلاک 69 انستیتو پاستور ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1316943551
Phone: +98 21 6695 3311
Fax: +98 21 6646 5132
Email: sarahdahmardeh@gmail.com
Web page address:
Name of recruitment center - English: Vaccination Department of Pasteur Institute of Iran Name of recruitment center - Persian: بخش واکسیناسیون انستیتو پاستور ایران Full name of responsible person - English: Dr. sarah Dahmardeh Full name of responsible person - Persian: دکتر سارا دهمرده Street address - English: No.69/No. 69, Pasteur Ave.13164Ave., Tehran , Iran Street address - Persian: خیابان پاستور پلاک 69 انستیتو پاستور ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1316943551 Phone: +98 21 6695 3311 Fax: +98 21 6646 5132 Email: sarahdahmardeh@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.Alireza Biglari
Full name of responsible person - Persian: دکتر علیرضا بیگلری
Street address - English: No.69/Ave.Pasteur-13164
Street address - Persian: خیابان پاستور پلاک 69
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1316943551
Phone: +98 21 6695 3311
Fax:
Email: biglari63@hotmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.Alireza Biglari
Full name of responsible person - Persian: دکتر علیرضا بیگلری
Street address - English: No. 69, Pasteur Ave., Tehran , Iran
Street address - Persian: خیابان پاستور پلاک 69
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1316943551
Phone: +98 21 6695 3311
Fax:
Email: biglari63@hotmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr.Alireza Biglari Full name of responsible person - Persian: دکتر علیرضا بیگلری Street address - English: No.69/Ave.Pasteur-13164No. 69, Pasteur Ave., Tehran , Iran Street address - Persian: خیابان پاستور پلاک 69 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1316943551 Phone: +98 21 6695 3311 Fax: Email: biglari63@hotmail.com Web page address:
Protocol summary
Study aim
Immunogenicity and safety evaluation of PastoCovac Plus as the booster dose in Iranian adults aged from 18 to 80 who received two doses of Sinofarm and Astrazeneca
Design
In this study, 190 adults (18 to 80 years old) were immunized with 2 doses of Sinopharm, Astrazeneca vaccine, which are administered in parallel and non-randomly.
Settings and conduct
Pasteur Institute of Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria: People 18 to 80 years of age who have received two doses of Sinopharm or Astrazeneca vaccine and three to six months after the second dose.
Inclusion criteria: Individuals with uncontrolled underlying disease and a history of receiving any type of vaccination other than Covid-19 three months prior to enrollment.
Intervention groups
First dose: Sinopharm, Second dose: Sinopharm, Booster: Pastocovac Plus (Iran).
First dose: Astrazeneca Second dose: Astrazeneca Booster: Pastocovac Plus (Iran).
First dose: Sinopharm, Second dose: Sinopharm, Booster: Sinopharm.
Groups of 20 people include:
First dose: Astrazeneca, second dose: Astrazeneca, third dose: Astrazeneca, First dose: Astrazeneca, second dose: Astrazeneca, third dose: Pastocovac Plus (Cuba)
Main outcome variables
SARS-CoV-2 Anti SPIKE IgG;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131221015878N3
Registration date:2022-01-18, 1400/10/28
Registration timing:registered_while_recruiting
Last update:2022-02-02, 1400/11/13
Update count:2
Registration date
2022-01-18, 1400/10/28
Registrant information
Name
Amitis Ramezani
Name of organization / entity
Pasteur Institute of Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6696 8852
Email address
amitisramezani@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-12, 1400/09/21
Expected recruitment end date
2022-04-10, 1401/01/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Immunogenicity and safety evaluation of Pastocovac Plus as the booster dose in Iranian adults aged from 18 to 80 who received two doses of Sinopharm and Astrazeneca
Public title
Immunogenicity and safety evaluation of Pastocovac Plus in Iranian adults who received two doses of Sinopharm and Astrazeneca
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Signed informed written consent
Able to follow the vaccination schedules, visits and tests
General health and controlled underlying diseases (based on the physician's recommendation)
Iranian citizenship
Resident in Tehran
Both sexes (male and female)
Aged above 18 years
Receiving 2 doses of Sinopharm vaccine with 28±5 days interval
Receiving 2 doses of Astrazeneca vaccine with 3 to 4 months interval
All candidates whose second vaccination either Sinopharm or Astrazeneca was done 3 to 6 prior to enrollment.
Exclusion criteria:
Having a history of vaccination against Covid-19 with other available vaccines
History of COVID-19 based on laboratory or clinical evidence after receiving the vaccine
History of any vaccinations except COVID-19 within 3 months prior to enrollment
Pregnant or breastfeeding women or those who intend to become pregnant up to 3 months after the booster dose injection.
Having uncontrolled hypertension (cytological pressure greater than 140 or diastolic pressure greater than 90 mm Hg)
History of receiving blood or blood products such as immunoglobulin in the last three months
Suffering from chronic kidney disease (GFR less than 30)
Suffering from chronic liver disease (liver enzymes more than 5 times normal: 150ALT≥, 100AST≥)
Suffering from uncontrolled asthma (Having had an asthma attack in the last three months)
History of severe allergic reaction (anaphylaxis) to the vaccine during a person's lifetime
History of treatment with immunosuppressive drugs 1 month before the booster injection (including oral and inhaled steroids (does not include topical steroids), cytostatic, interferon, immunoferon, transfer factor, Biomodulin T, any type of gammaglobin, levamisole , Heberferon, thymosin or any other immunomodulatory drug (including patients taking the above drugs due to an underlying disease).
Having a fever or acute illness during the 7 days before the injection or on the day of the booster injection
Suffering from an unstable heart disease
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
190
More than 1 sample in each individual
Number of samples in each individual:
2
Blood sample before he booster dose and one month after that
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Pasteur Institute of Iran (Research Ethics Committee)
Street address
No. 69, Pasteur Ave., Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1316943551
Approval date
2021-12-12, 1400/09/21
Ethics committee reference number
IR.PII.REC.1400.076
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U11
ICD-10 code description
Need for immunization against COVID-19
2
Description of health condition studied
Covid-19
ICD-10 code
U07
ICD-10 code description
COVID-19, virus identified & not identified
Primary outcomes
1
Description
Increased Anti-Spike headline
Timepoint
At the beginning of the study (before the intervention) and one month after the intervention (receiving a booster dose)