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: Injection of 1 dose of Pastocovac vaccine as a booster dose, 3-6 months after receiving 2 doses of Sinopharm vaccine. The Pastocovac vaccine, produced by the Pasteu
Sponsors
Pasture Institute of Iran
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Signed written informed consent Able to follow the vaccination schedules, visits and tests General health or having controlled underlying diseases (based on the physician's diagnosis) Iranian citizenship Residents of Tehran Both sexes (male and female) Aged 18-80 years Receiving the initial 2 doses of Sinopharm within a 28±5 days interval Completion of the 2-dose Sinopharm vaccination course within 3-6 months prior enrollment.
Exclusion criteria
Exclusion criteria: Having a history of vaccination against Covid-19 with other vaccines (in addition to 2 doses of Sinopharm) History of COVID-19 based on laboratory or clinical evidence after receiving 2 doses of Sinopharm 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 Lifetime history of severe allergic reactions (anaphylaxis) to the vaccine Coagulation disorders that contraindicate with intramuscular injection 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 21,60,90,180 days 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.;Increased Anti RBD headline. Timepoint: At the beginning of the study (before the intervention) and 21,60,90,180 days after the intervention (receiving a booster dose). Method of measurement: Quanti-SARS-CoV-Anti-RBD ELISA (IgG) Kit, Pishtaz co.;Increased cVNT headline. Timepoint: At the beginning of the study (before the intervention) and 21,60,90,180 days after the intervention (receiving a booster dose). Method of measurement: SARS-CoV-2 Neutralizing Ab Elisa kit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaccine safety assessment. Timepoint: At the beginning of the study (before the intervention) and 7,21,60,90,180 days after the intervention (receiving a booster dose). Method of measurement: Compilation form, clinical examination and telephone follow-up. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSarah Dahmardeh
Pasture Institute of Iran
Outcome results
None listed