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Study aim: Evaluation of Immunogenicity and safety of Noora vaccine as a booster. Design: This clinical trial is designed as a hybrid (in the form of two separate trials) in phase 3: ّ First A randomized, double blind clinical trial with two parallel groups and a single center with a sample size of 300 people. Second A multicenter and single arm clinical trial comparing before and after injection of booster vaccine with a sample size of 10000 people. Settings and conduct: The first part in the single center of Shahid Soleimani will be randomly double blind with parallel groups to check the immunogenicity . Blinding ratio will be 1: 2 and the volunteer, researcher and executive staff are unaware of the nature of the injection. The second ward will be in one of the 10 affiliated centers of Baqiyatallah Hospital, before and after. After injection, possible allergic reactions and other reactions will be recorded. Participants/Inclusion and exclusion criteria: Inclusion criteria include: over 18 years of age, candidates who have received two identical doses of the specified approved vaccine by MOH, and at least 3 months after the second dose, fully understand the provisions of the consent form and sign it. Exclusion criteria include: COVID19 infection in the past two months, quarantine, history of certain diseases, medication received in the last 3 months, receiving immunoglobulin or blood products in the previous 3 months, pregnant women Or breastfeeding or intending to pregnancy Intervention groups: Including two intervention groups 1) Injection of 80 μg of recombinant RBD protein vaccine 2) Injection of a placebo dose Main outcome variables: Primary Outcomes: Comparison of antibody levels in a sample of 300 volunteers on days 0 and 21 after injection. Cell immune response to booster dose and measurement of neutralized antibody level in 90 subgroups.
IRCTID: IRCT20210620051639N3
  1. Immunogenicity and Safety of intranasal Razi Cov Pars as a booster dose in adult population; randomised, double blind, placebo controlled clinical trial
  2. A double-blind, randomized, placebo-controlled Phase II clinical trial to evaluate the immunogenicity and safety of covid-19 recombinant RBD protein vaccine (80 microgram) of Plasma Darman Sarve Sepid Co. in healthy population.
  3. Comparison of safety and immunogenicity of FAKHRAVAC and Sinopharm booster doses for adults 18 years of age and older, fully vaccinated by Sinopharm: a ‎parallel ‎‏2‏‎ arms, ‎randomised, double blind clinical trial
  4. Comparison of immunogenicity and safety of Razi Cov Pars and Sinopharm booster doses in adults 18 years of age and older who have primarily vaccinated with Sinopharm: a ‎parallel ‎‏2‏‎ arms, ‎randomised, double blind clinical trial ‎
  5. A single armed, open label, clinical trial to evaluate the immunogenicity of SpikoGen® vaccine as booster dose (Spike protein, produced by CinnaGen company) in kidney transplant patients being fully vaccinated with Sinopharm vaccine
  6. Phase II, Safety and Immunogenicity of RAZI SARS-CoV-2 recombinant Spike protein vaccine (RAZI Cov Pars) in adults aged 18-70 years; a Randomised, double blind, parallel 2 arms clinical trial
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  8. Phase I, Safety and Immunogenicity of Razi SARS-CoV-2 recombinant Spike protein vaccine (Razi Cov Pars), in healthy adults aged 18-55 years; parallel 4 arms design (adjuvant only and three vaccine doses of 5, 10, and 20 µg/200µl); a Randomised, double blind, clinical trial
  9. 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
  10. Phase 2 trial of safety and immunogenicity of 10 micro gram inactivated SARS-CoV-2 vaccine (FAKHRAVAC), two doses two weeks apart in adults aged 18-70 years: a randomized, double-blind, placebo-controlled, clinical trial
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