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
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...
February 24, 2023: BMC Infectious Diseases