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Objective To report the efficacy, safety, and exploratory immunogenicity findings of two 5 µg doses of the BIV1-CovIran vaccine. Design Randomised, placebo controlled, double blind, multicentre, phase 3 clinical trial. Setting In six cities of Iran, including Bushehr, Isfahan, Karaj, Mashhad, Shiraz, and Tehran. The first vaccine or placebo injection of the first participant was on 16 May 2021 in Tehran. The last vaccine or placebo injection of the last participant occurred on 15 July 2021 in Isfahan. Participants 20 000 participants aged 18-75 years were randomly assigned to the intervention or placebo groups with a ratio of 2:1. Intervention 5 µg vaccine or placebo with the interval of 28 days. Main outcome measures Vaccine efficacy for a 90 day follow-up period, safety and explanatory immunogenicity assessment, and variant detection during the trial. Results 20 000 participants were recruited and randomly assigned to receive BIV1-CovIran (n=13 335 (66.7%)) or placebo (

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