CanSino Publishes Phase I Data for COVID-19 Vaccine Candidate, Moves into Phase II
A COVID-19 vaccine candidate under development by China’s CanSino Biologics is moving forward in development after the company published data supporting its safety in patients.
In an article published in The Lancet this morning, CanSino noted it tested different dose levels of its Ad5 vectored COVID-19 vaccine candidate in 108 patients from Wuhan, China, thought to be the origin of the novel coronavirus that has swept across the globe in a matter of months. The primary endpoint of the Phase I trial was to note adverse events one week after vaccination and the patients were followed for a total of 28 days thereafter. Most adverse reactions reported in all three dose groups were mild or moderate in severity and no serious adverse event was noted within 28 days post-vaccination, the company said. The most common adverse reactions were fever, fatigue, headache and muscle pain.
Additionally, CanSino said specific antibodies were measured with ELISA, and the neutralizing antibody responses induced by vaccination were detected with SARS-CoV-2 virus neutralization and pseudovirus neutralization tests. ELISA antibodies and neutralizing antibodies increased significantly at day 14 and peaked 28 days post-vaccination. Specific T-cell response peaked at day 14 post-vaccination, the company said. The antibody response to the vaccine in the high dose group was slightly greater than that in the middle dose and low dose groups, CanSino said.
“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 its journal article.
There are more than 100 different vaccine candidates for the novel coronavirus in development and CanSino becomes the first company chasing a vaccine for COVID-19 to publish findings from a clinical study. Earlier this week, Massachusetts-based Moderna announced preliminary Phase I data that shows both safety and efficacy for its mRNA vaccine. Data the company released was limited to a handful of trial participants, so at this point it is largely unknown how effective that vaccine candidate could be, but the company was optimistic. A Phase II study of Moderna’s vaccine is underway and the company is already eying a Phase III study in the early summer should the mid-stage trial go well.
Like Moderna, CanSino has begun to move its vaccine candidate into Phase II. That decision was announced last month following the release of its own preliminary Phase I data. Ad5-nCoV is a genetic engineered vaccine candidate with the replication-defective adenovirus type 5 as the vector to express SARS-CoV-2 spike protein, which intends to be used to prevent the disease caused by the novel coronavirus infection, the company said in its filing. Ad5-nCoV is built upon CanSino BIO’s adenovirus-based viral vector vaccine technology platform, which has also been applied to develop a vaccine against Ebola. CanSino said the Phase II study will provide more information on the safety and immunogenicity of its Ad5 vectored COVID-19 vaccine.