CanSino Bio COVID-19 Vaccine Candidate Moves into Phase II After Publishing Promising Phase I Results

CanSino Biologics Inc. (Tianjin, China) is moving forward the development of its COVID-19 vaccine candidate to Phase II after publishing data supporting its safety in patients in its Phase I trial.

In the Phase I trial of its Ad5 vectored COVID-19 vaccine candidate, the company administered different dose levels in 108 patients from Wuhan, China, with the aim of to noting any adverse events a week after vaccination and followed up with the patients for a total of 28 days thereafter. CanSino found most adverse reactions reported in all three dose groups to be mild or moderately severe and observed no serious adverse event within 28 days post-vaccination, with the most common adverse reactions were fever, fatigue, headache and muscle pain.

CanSino also measured specific antibodies measured with ELISA and detected the neutralizing antibody responses induced by vaccination with SARS-CoV-2 virus neutralization and pseudovirus neutralization tests. The company found a significant increase in ELISA antibodies and neutralizing antibodies at day 14 and a peak 28 days post-vaccination. Specific T-cell response peaked at day 14 post-vaccination, according to CanSino, which found a slightly greater antibody response to the vaccine in the high dose group as compared to the middle dose and low dose groups.

“The Ad5 vectored COVID-19 vaccine is tolerable and immunogenic at 28 days post-vaccination. Humoral responses against SARS-CoV-2 peaked at day 28 post-vaccination in healthy adults, and rapid specific T-cell responses were noted from day 14 post-vaccination. Our findings suggest that the Ad5 vectored COVID-19 vaccine warrants further investigation,” CanSino wrote in the Phase I data published in The Lancet.

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