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Study aim: Dose finding, safety and immunogenicity of recombinant protein sub-unit Covid vaccine developed by RAZI institute (Razi Cov Pars) Design: Phase I, randomized, double blind, placebo controlled trial will be conducted on 133 healthy volunteers including 13 sentinel and 120 participants randomly allocated to 4 study groups. Settings and conduct: Terhan Rasoul Akram Hospital Participants/Inclusion and exclusion criteria: Important inclusion criteria: Iranian nationals; Diploma and above; 18 - 55 years old; healthy based on clinical & laboratory criteria; Negative RT-PCR tests for COVID, Negative S antibody titer; Signed informed consent, Non pregnant or lactating (women); Important exclusion criteria: Any ongoing, symptomatic acute or chronic illness requiring medication or surgery (including respiratory/cardiac diseases, hypertension, diabetes, neurological diseases, serious psychiatric disorder & blood disorders that diagnosed by a physician); Breastfeeding; History of allergic diseases or reaction to the drug/vaccine Intervention groups: The four study groups consists of three vaccine groups receiving 5, 10, 20 µg/200µL intramascular doses on day 0 and 21 followed by 10 µg/200µl intranasal spray on day 51. The fourth group receives adjuvant only on day 0, and 21 (intramascular ) and 51 (intranasal spray). Main outcome variables: Primary outcomes: Immediate abnormal vital signs & anaphylactic reactions after vaccination: Local & Systemic adverse events within the first week post-vaccination: Abnormal lab. findings Secondary outcomes: Occurrence of COVID-19 disease 2 weeks after 2nd vaccine dose: SAEs, SUSARs, MAAEs, up to 6 months after last vaccine dose: Serum ELISA IgG level for SARS-CoV-2 antigens S، S1, N, S2, NTD، RBD; Serum ELISA IgA level for RBD; Neutralizing antibody activity cVNT; Cell-mediated immunity up to 5 months after start of vaccination.
IRCTID: IRCT20201214049709N1
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  2. Safety and Immunogenicity of Razi Cov-2 recombinant Spike protein vaccine (RAZI Cov Pars) in healthy children and adolescents aged 5-17 years; single group, open label study
  3. Immunogenicity and Safety of intranasal Razi Cov Pars as a booster dose in adult population; randomised, double blind, placebo controlled clinical trial
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  5. Comparison of the safety and efficacy of Razi SARS-CoV-2 recombinant Spike protein (Razi Cov Pars) and Sinopharm vaccines in adults aged 18 and over, a phase III randomised, double blind, non-inferiority clinical trial
  6. 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 ‎
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