| Autor: |
Akram Ansarifar, Ramin Hamidi Farahani, Ahmad Karimi Rahjerdi, Mohammadreza Ahi, Ali Sheidaei, Kimiya Gohari, Zahra Rahimi, Fatemeh Gholami, 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, Hooman Bakhshande, Zahra Taghva, Mohammad Karimi Nia, Masoud Solaymani Dodaran, Mohsen Foroughizadeh |
| Jazyk: |
angličtina |
| Rok vydání: |
2023 |
| Předmět: |
|
| Zdroj: |
Vaccine: X, Vol 15, Iss , Pp 100401- (2023) |
| Druh dokumentu: |
article |
| ISSN: |
2590-1362 |
| DOI: |
10.1016/j.jvacx.2023.100401 |
| Popis: |
Background: The FAKHRAVAC®, an inactivated SARS-CoV-2 vaccine, was assessed for safety and immunogenicity. Methods and findings: In this double-blind, placebo-controlled, phase I trial, we randomly assigned 135 healthy adults between 18 and 55 to receive vaccine strengths of 5 or 10 μg/dose or placebo (adjuvant only) in 0–14 or 0–21 schedules. This trial was conducted in a single center in a community setting. The safety outcomes in this study were reactogenicity, local and systemic adverse reactions, abnormal laboratory findings, and Medically Attended Adverse Events (MAAE). Immunogenicity outcomes include serum neutralizing antibody activity and specific IgG antibody levels.The most frequent local adverse reaction was tenderness (28.9%), and the most frequent systemic adverse reaction was headache (9.6%). All adverse reactions were mild, occurred at a similar incidence in all six groups, and were resolved within a few days. In the 10-µg/dose vaccine group, the geometric mean ratio for neutralizing antibody titers at two weeks after the second injection compared to the placebo group was 9.03 (95% CI: 3.89–20.95) in the 0–14 schedule and 11.77 (95% CI: 2.77–49.94) in the 0–21 schedule. The corresponding figures for the 5-µg/dose group were 2.74 (1.2–6.28) and 5.2 (1.63–16.55). The highest seroconversion rate (four-fold increase) was related to the 10-µg/dose group (71% and 67% in the 0–14 and 0–21 schedules, respectively). Conclusions: FAKHRAVAC® is safe and induces a strong humoral immune response to the SARS-CoV-2 virus at 10-µg/dose vaccine strength in adults aged 18–55. This vaccine strength was used for further assessment in the phase II trial.Trial registrationThis study is registered with https://www.irct.ir; IRCT20210206050259N1. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
|
