CinnaGen Initiates a Phase 3 Clinical Trial of Vaxine’s COVID-19 Vaccine Technology
On August 07, 2021, the first volunteer enrolled in the Phase 3 clinical study of Cinnagen’s COVID-19 vaccine candidate in Iran. The study is a randomized, double-blind, placebo-controlled trial and will evaluate the efficacy and safety of the vaccine in 16,876 adult participants. Subjects receive two doses, 21 days apart, of either Spikogen vaccine or saline placebo in a 3:1 ratio. As of August 27, 2021, more than 10,000 volunteers have received the first dose of the study injection. Individuals will be followed up for six months. This study will provide data on the ability of Spikogen vaccine to prevent COVID-19 including severe disease. The trial is being conducted while Delta is now the dominant variant in Iran. Cinnagen moved to this large-scale Phase 3 clinical trial after having promising preliminary results from an ongoing Phase 2 clinical study, which started on May 30, 2021. Vaxine’s coronavirus vaccine technology is known as COVAX-19 in Australia and SpikoGen produced by Cinnagen in Iran.