BMC Infectious Diseases (Feb 2023)

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

  • 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

DOI
https://doi.org/10.1186/s12879-023-08079-1
Journal volume & issue
Vol. 23, no. 1
pp. 1 – 9

Abstract

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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)

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