CinnaGen’s Phase III investigation of the protein subunit Covid-19 vaccine SpikoGen will likely have data within the next two months, vaccine developer Nikolai Petrovsky said. The 16,876-volunteer trial administered the final dose of the two-shot vaccine in the past few days, he added.

SpikoGen was developed by Adelaide, Australia-based Vaxine, and CinnaGen sponsored the Phase III study in Tehran, Iran, where it is headquartered. Petrovsky is the chairman of Vaxine, which is listed as a trial collaborator.

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SpikoGen features the SARS-CoV-2 spike protein and Vaxine’s own Advax-SM adjuvant. While Novavax’s NVX-CoV2373 has the highest public profile among Covid-19 protein subunit vaccines, it has yet to secure authorisation anywhere.

SpikoGen: swift recruitment due to local interest

The Phase III SpikoGen trial completed recruitment in four weeks, Petrovsky said, noting that the two doses are administered with a 21-day gap. The first volunteer in the Phase III study was enrolled on 7 August. There is public interest in vaccines that use traditional technologies, like SpikoGen, compared to newer approaches such as mRNA and adenovirus-vectored vaccines, Petrovsky noted.

The placebo-controlled SpikoGen trial has coprimary endpoints investigating the occurrence of symptomatic Covid-19 and severe Covid-19, with both endpoints collected two weeks after the second dose. Investigators are waiting for just under 100 events to trigger an efficacy analysis, Petrovsky added. On 14 September, 22,361 new confirmed Covid-19 cases were reported in Iran, with the country peaking for the third time at 39,795 cases on 17 August, according to Our World in Data.

In the Phase III, participants received either SpikoGen or placebo in a 3:1 ratio. Participants were divided into two groups with the first recruiting volunteers aged 18–40 years and the second enrolling people aged 40–50 years. The study’s status on ClinicalTrials.gov page is listed as recruiting and was last updated on 13 August.