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

BMC Infectious Diseases

Research

Ramin Hamidi Farahani¹  Masoud Solaymani Dodaran²  Akram Ansarifar²  Ali Sheidaei²  Hooman Bakhshande²  Zahra Rahimi²  Mohammadreza Ahi²  Kimiya Gohari²  Fatemeh Gholami³  Mohsen Forooghizade⁴  Arina Monazah⁵  Samane Khodaverdloo⁵  Hossein Allahyari⁵  Hajar Mehr Azin⁵  Pezhman Khatami⁵  Ali Khodaei Poor⁵  Batool Shafaghi⁵  Milad Moradi⁵  Mohsen Honari⁵  Mohammad Karimi Nia⁵  Zahra Taghva⁵  Arash Jahangiri⁵  Pouria Basiri⁵  Mohammad Shooshtari⁵  Sohrab Moradi⁵  Soheil Ghasemi⁵  Ahmad Karimi Rahjerdi⁶  Kosar Naderi⁶ 

[1] AJA University of Medical Sciences, Tehran, Iran;Clinical Trial Center of Iran University of Medical Sciences, Tehran, Iran;Department of Epidemiology, School of Public Health, Iran University of Medical Sciences, Tehran, Iran;Clinical Trial Center of Iran University of Medical Sciences, Tehran, Iran;Malek Ashtar University of Technology, Tehran, Iran;Milad Daro Noor Pharmaceutical (MDNP) Company IR, Tehran, Iran;Milad Daro Noor Pharmaceutical (MDNP) Company IR, Tehran, Iran;Stem Cell Technology Research Center (STRC), Tehran, Iran;

关键词: COVID-19;    SARS-CoV-2;    Inactivated vaccine;    Phase II clinical trial;   

DOI  :  10.1186/s12879-023-08079-1

 received in 2022-07-24, accepted in 2023-02-13,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThe FAKHRAVAC®, an inactivated SARS-CoV-2 vaccine, was assessed for safety and immunogenicity in a phase II trial.MethodsWe 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.ResultsFive 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).ConclusionsFAKHRAVAC® 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)

【 授权许可】

CC BY   
© The Author(s) 2023

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