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IRCT20131221015878N4 IRCT 2022-02-26 Pasture Institute of Iran Immunogenicity and safety of pastocovac vaccine as a booster dose in recipients of 2 doses of Sinopharm vaccine Immunogenicity and safety of pastocovac vaccine as a booster dose in comparison with sinopharm and pastocovac Plus boosters in Iranian adults aged 18 to 80 who received 2 doses of Sinopharm vaccine: a parallel group clinical trial 2022-02-26 anticipated 225 Complete https://irct.ir/trial/62108 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. N/A Condition 1: COVID-19. Condition 2: COVID-19. 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 Pasteur Institute of Iran, is injected intramuscularly into the deltoid muscle (0.5 ml, containing 25 micrograms of RBD conjugated with tetanus). Intervention 2: Control group 1: injection of 1 dose of Pastocovac-Plus vaccine as a booster dose, 3-6 months after receiving 2 doses of Sinopharm vaccine. Pastocovac vaccine, produced by the Pasteur Institute of Iran, is injected intramuscularly into the deltoid muscle (0.5 ml, containing 50 micrograms of RBD dimer). Intervention 3: Control group 2: injection of 1 dose of Sinopharm vaccine as a booster dose, 3-6 months after receiving 2 doses of Sinopharm vaccine. The Sinopharm vaccine, produced by the Beijing Institute of Biological Products, is injected intramuscularly into the deltoid muscle (containing 6.5 units of inactivated virus). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست
public Sarah Dahmardeh
No. 69, Pasteur Ave., Tehran , Iran
Tehran Iran (Islamic Republic of) 1316943551 +98 21 6695 3311 sarahdahmardeh@gmail.com Pasture Institute of Iran scientific Amitis Ramezani
No.69, Ave pasteur, Tehran, Iran
Tehran Iran (Islamic Republic of) 131693551 +98 21 6411 2812 Amitisramezani@hotmail.com Pasture Institute of Iran Iran (Islamic Republic of) 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. 18 years 80 years Both 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 U11 U07 Need for immunization against COVID-19 COVID-19, virus identified & not identified Prevention Prevention Prevention 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 Pasteur Institute of Iran, is injected intramuscularly into the deltoid muscle (0.5 ml, containing 25 micrograms of RBD conjugated with tetanus). Control group 1: injection of 1 dose of Pastocovac-Plus vaccine as a booster dose, 3-6 months after receiving 2 doses of Sinopharm vaccine. Pastocovac vaccine, produced by the Pasteur Institute of Iran, is injected intramuscularly into the deltoid muscle (0.5 ml, containing 50 micrograms of RBD dimer). Control group 2: injection of 1 dose of Sinopharm vaccine as a booster dose, 3-6 months after receiving 2 doses of Sinopharm vaccine. The Sinopharm vaccine, produced by the Beijing Institute of Biological Products, is injected intramuscularly into the deltoid muscle (containing 6.5 units of inactivated virus). 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. 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. Pasture Institute of Iran Approved 2022-02-06 Pasteur Institute of Iran (Research Ethics Committee) No. 69, Pasteur Ave., Tehran , Iran Tehran Tehran Iran (Islamic Republic of)