Immunogenicity and safety of pastocovac vaccine as a booster dose in recipients of 2 doses of Sinopharm vaccine

Not Applicable

Recruiting

• Conditions: Condition 1: COVID-19. Condition 2: COVID-19.; Need for immunization against COVID-19; COVID-19, virus identified & not identified

• Registration Number: IRCT20131221015878N4
• Lead Sponsor: Pasture Institute of Iran

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 225

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

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

Study & Design

• Study Type: interventional
• 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 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 Outcome Measures

Name	Time	Method
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.