Phase II randomized, double blind, placebo controlled, clinical trial of safety and immunogenicity of an inactivated SARS-CoV-2 vaccine FAKHRAVAC in adults aged 18–70 years
oleh: Fatemeh Gholami, Ramin Hamidi Farahani, Ahmad Karimi Rahjerdi, Mohammadreza Ahi, Ali Sheidaei, Kimiya Gohari, Zahra Rahimi, Akram Ansarifar, Pouria Basiri, Milad Moradi, Arash Jahangiri, Kosar Naderi, Soheil Ghasemi, Pezhman Khatami, Mohsen Honari, Samane Khodaverdloo, Mohammad Shooshtari, Hajar Mehr Azin, Sohrab Moradi, Batool Shafaghi, Hossein Allahyari, Arina Monazah, Ali Khodaei Poor, Zahra Taghva, Hooman Bakhshande, Mohammad Karimi Nia, Masoud Solaymani Dodaran, Mohsen Forooghizade
| Format: | Article |
|---|---|
| Diterbitkan: | BMC 2023-02-01 |
Deskripsi
Abstract Background The FAKHRAVAC®, an inactivated SARS-CoV-2 vaccine, was assessed for safety and immunogenicity in a phase II trial. Methods We did a phase II, single-centered, randomized, double-blind, placebo-controlled clinical trial of the FAKHRAVAC inactivated SARS-CoV-2 vaccine on adults aged 18 to 70. The two parallel groups received two intramuscular injections of either a 10-µg vaccine or a placebo at 2-week intervals. The participants' immunogenicity responses and the occurrence of solicited and unsolicited adverse events were compared over the study period of up to 6 months. Immunogenicity outcomes include serum neutralizing antibody activity and specific IgG antibody levels. Results Five hundred eligible participants were randomly (1:1) assigned to vaccine or placebo groups. The median age of the participants was 36 years, and 75% were male. The most frequent local adverse reaction was tenderness (21.29% after the first dose and 8.52% after the second dose), and the most frequent systemic adverse reaction was headache (11.24% after the first dose and 8.94% after the second dose). Neutralizing antibody titers two and four weeks after the second injection in the vaccine group showed about 3 and 6 times increase compared to the placebo group (GMR = 2.69, 95% CI 2.32–3.12, N:309) and (GMR = 5.51, 95% CI 3.94–8.35, N:285). A four-fold increase in the neutralizing antibody titer was seen in 69.6% and 73.4% of the participants in the vaccine group two and four weeks after the second dose, respectively. Specific ELIZA antibody response against a combination of S1 and RBD antigens 4 weeks after the second injection increased more than three times in the vaccine compared to the placebo group (GMR = 3.34, 95% CI 2.5–4.47, N:142). Conclusions FAKHRAVAC® is safe and induces a significant humoral immune response to the SARS-CoV-2 virus at 10-µg antigen dose in adults aged 18–70. A phase III trial is needed to assess the clinical efficacy. Trial registration: Trial Registry Number: Ref., IRCT20210206050259N2 ( http://irct.ir ; registered on 08/06/2021)