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Mohraz M, Salehi M, Tabarsi P, et al. Safety and immunogenicity of an inactivated virus particle vaccine for SARS-CoV-2, BIV1-CovIran: findings from double-blind, randomised, placebo-controlled, phase I and II clinical trials among healthy adults. BMJ Open 2022;12:e056872. doi: 10.1136/bmjopen-2021-056872
In the corrected version of the article, the competing interest statements for authors Hamed Hosseini, Minoo Mohraz, and Payam Tabaris have been changed. The original article indicated they had no competing interests. It now states the following:
HH: as manager of the Clinical Trial Center (CTC), an academic CRO affiliated with Tehran University of Medical Sciences, Tehran, Iran, I was responsible for the conduct and monitoring of clinical trials. I was a non-voting member of the Data Safety Monitoring Board, as mandated by the national regulatory authority.
MM: a research contract between Shifapharmed (sponsor) and Iranian Research Centre for HIV/AIDS (IRCHA) for supervising all clinical trial activities of phases one and two has been signed for 1575 million Iranian rials, which has been deposited into the account number of this centre at Tehran University of Medical Sciences. My position at the time was director of this centre; as such, the payment appears to be transferred to my name in Shifa’s financial statements.
PT: I had the role of principal investigator in another vaccine project (Spikogen).
The funding statement was corrected to include the organisations of which Shifa is a part. The funding statement previously stated, “The project was funded by Shifa Pharmed Industrial Group”. It now states, "The project was funded by Shifa Pharmed Industrial Group. Shifa Pharmed is a part of Barkat Pharmaceutical Group, which belongs to EIKO/Setad”.
A sentence of the conclusion was overstated. It said, “Administration of the two shots of 5 µg dose BIV1-CovIran vaccine with a 28-day interval would enhance the immunity of all vaccine recipients against SARS-CoV-2 with no vaccine-related SAEs. The conclusion now says, “Administration of the two shots of 5 µg dose BIV1-CovIran vaccine with a 28-day interval has demonstrated the potential to enhance the immunity of vaccine recipients against SARS-CoV-2 with no serious vaccine-related SAEs”. The remainder of the concluding remarks are accurate.
A tracked changes online supplemental file 1 is appended to the paper for transparency.
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