Immunogenicity and safety evaluation of Pastocovac Plus in Iranian adults who received two doses of Sinopharm and Astrazeneca
- Conditions
- Condition 1: Covid-19. Condition 2: Covid-19.Need for immunization against COVID-19COVID-19, virus identified & not identified
- Registration Number
- IRCT20131221015878N3
- Lead Sponsor
- Pasture Institute of Iran
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 190
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.
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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Increased Anti-Spike headline. Timepoint: At the beginning of the study (before the intervention) and one month after the intervention (receiving a booster dose). Method of measurement: Antibody titer with ELISA Kit Anti-SARS-CoV-2 QuantiVac ELISA (IgG) Kit, Euroimmun co.;Quadrupling the neutralizing antibody titer. Timepoint: At the beginning of the study (before the intervention) and one month after the intervention (receiving a booster dose). Method of measurement: SARS-CoV-2 Neutralizing Ab Elisa kit.
- Secondary Outcome Measures
Name Time Method Evaluating safety of Booster dose. Timepoint: During 30 mins till one month after intervention. Method of measurement: Visiting cases(days 0,30) and follow up cases every two weeks by phone call.