Interim analysis of Japan trial for S 268019 vaccine for COVID 19 confirms no major safety concerns, increase in antibody titers.

The study was designed to look into the safety, tolerability, and immunogenicity of S 268019, a recombinant protein-based vaccine in Japanese adults (including people who have no history of coronavirus infection or vaccination, vaccinated subjects, as well as unvaccinated subjects with a history of infection) and elderly individuals.

Adverse events that emerged up to 7 days after the S 268019 vaccination included fever, nausea/vomiting, diarrhea, headache, malaise, muscle pain, injection site pain, erythema/redness, induration, and swelling at the injection site. Although these reactions were reported, Shionogi said the interim analysis confirmed the tolerability of the vaccine, with no serious safety signals identified. The company also said that there was no major difference in the incidence of these events between cohorts based on vaccination/infection history.

On the immunogenicity front, the ratio of subjects that logged SARS-CoV-2 neutralizing antibody titers four times or more than the baseline 28 days after the second shot came to 95.9% for “naïve adults” with no history of infection or vaccination, 100% for vaccinated adults, 97.0% for unvaccinated subjects with a history of infection, and 85.5% for “naïve elderly.”

Shionogi is currently running five late-stage trials for S 268019, including this program. In February, it started preliminary talks with the Pharmaceuticals and Medical Devices Agency (PMDA) towards the vaccine’s regulatory submission in Japan.