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CanSino Publishes Positive Phase II Data on COVID-19 Vaccine

publication date: Jul 21, 2020
 | 
author/source: Richard Daverman, PhD

In a Lancet article, Tianjin's CanSino Bio (HK: 6185) published positive early results from a Phase II trial of its COVID-19 vaccine. The vaccine induced antibodies to the coronavirus and a T cell response in 85% of the participants, with a low level of adverse reactions. The trial, conducted in Wuhan, randomized patients to two doses of the vaccine or a placebo. Last week, CanSino said it is in negotiations to start a Phase III trial that enrolls 40,000 volunteers outside of China in countries where the COVID-19 pandemic is prevalent.

CanSino's vaccine is delivered by an adenovirus type-5 (Ad5)-vector, which lowered the response in subjects who have previously been dosed with a similar vector. A second dose is expected to produce a sufficient response in this subject group, while a single dose is enough for the vector-naive subjects. The trial enrolled healthy adults aged 18 years or older, who were HIV-negative and free of SARS-CoV-2 infection

In the 1 × 10¹¹ and 5 × 10¹⁰ viral particles dose groups, the binding domain specific antibodies peaked at 656.6 (95% CI 575.2–749.2) and 571.0 (467,6–697.3), with seroconversion rates at 96% (95% CI 93–98) and 97% (92–99), at day 28 in participants receiving high and low doses, respectively.

Both doses of the vaccine induced significant neutralizing antibody responses to live SARS-CoV-2, with geometrical mean titers of 19.5 (95% CI 16.8–22.7) and 18.3 (14.4–23.3) respectively.

In March, CanSino's Ad5-nCov vaccine was the first China vaccine candidate to begin clinical trials. Its adenovirus-based viral vector mechanism was developed in partnership with China's Academy of Military Medicine. The two entities built the COVID-19 vaccine based on their experience developing an adenovirus-based Ebola vaccine for the 2014-16 outbreak of the earlier coronavirus.

CanSino has been building a vaccine production facility and believes it will be ready to produce between 100 million to 200 million doses of the vaccine per year, beginning in 2021.

See our other articles on CanSino.

Disclosure: Dongxu Qiu, PhD, Executive Director and Co-Founder of CanSino, was China General Manager of ChinaBio® from 2007 to 2012.

 


 

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