Condition 1: Covid-19. Condition 2: Covid-19. Need for immunization against COVID-19 COVID-19, virus identified & not identified
Conditions
Interventions
Intervention 1: Intervention group: Intervention group: People receiving two doses of Sinopharm as Pastocovac Plus booster. Intervention 2: Intervention group: Intervention group: People receiving two
Sponsors
Pasture Institute of Iran
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSarah Dahmardeh
Pasture Institute of Iran
Outcome results
None listed