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

• Published in: BMC infectious diseases 2023-02, Vol.23 (1), p.118-118, Article 118
• Main Authors: Gholami, Fatemeh, Hamidi Farahani, Ramin, Karimi Rahjerdi, Ahmad, Ahi, Mohammadreza, Sheidaei, Ali, Gohari, Kimiya, Rahimi, Zahra, Ansarifar, Akram, Basiri, Pouria, Moradi, Milad, Jahangiri, Arash, Naderi, Kosar, Ghasemi, Soheil, Khatami, Pezhman, Honari, Mohsen, Khodaverdloo, Samane, Shooshtari, Mohammad, Mehr Azin, Hajar, Moradi, Sohrab, Shafaghi, Batool, Allahyari, Hossein, Monazah, Arina, Khodaei Poor, Ali, Taghva, Zahra, Bakhshande, Hooman, Karimi Nia, Mohammad, Solaymani Dodaran, Masoud, Forooghizade, Mohsen
• Format: Article
• Language: English
• Subjects: Adults; Aluminum; Antibodies; Antibody response; Antigens; Clinical trials; Control; Coronaviruses; COVID-19; COVID-19 vaccines; Deactivation; Double-blind studies; Epidemics; IgG antibody; Immune response; Immune response (humoral); Immune system; Immunization; Immunogenicity; Immunoglobulin G; Inactivated vaccine; Injection; Injections; Iran; Laboratories; Neutralizing; Pandemics; Phase II clinical trial; Placebos; Safety; SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; Side effects; Statistical analysis; Testing; Vaccines
• ISSN: 1471-2334; 1471-2334
• DOI: 10.1186/s12879-023-08079-1

The FAKHRAVAC®, an inactivated SARS-CoV-2 vaccine, was assessed for safety and immunogenicity in a phase II trial. 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. 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). 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 Registry Number: Ref., IRCT20210206050259N2 ( http://irct.ir ; registered on 08/06/2021).