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Safety and Immunogenicity of a China-developed COVID-19 vaccine candidate proved in phase 2 clinical trials
Source: Global Times
A COVID-19 vaccine candidate developed by Chinese researchers proved safe and able to induce immunogenicity with low does, according to a report released on The Lancet on Monday.
The vaccine is a recombinant novel coronavirus vaccine jointly developed by Chinese top vaccine researcher Chen Wei and Chinese biopharmaceutical company CanSinoBIO.
The phase 2 trial was randomized, double-blind and placebo-controlled trial conducted in a single center in Wuhan, Central China's Hubei Province. There were 508 volunteers over the age of 18 who participated in the trial, according to The Lancet report.
The vaccine induced seroconversion of the neutralizing antibodies in 59 percent and 47 percent of the participants, and seroconversion of binding antibody in 96 percent and 97 percent of participants, in the 1×10¹¹ and 5×10¹⁰ viral particles dose groups, respectively.
A single injection of the vaccine at 1×10¹¹ viral particles and 5×10¹⁰ viral particles induced comparable specific immune responses to the spike glycoprotein at day 28, with no significant differences noted between the two groups, according to the report.
No serious adverse events were documented within 28 days, the authors said.
This study is the first randomized controlled trial for evaluation of the immunogenicity and safety of a candidate non-replicating Ad5-vectored COVID-19 vaccine, the authors said.
Source: Global Times
The vaccine is a recombinant novel coronavirus vaccine jointly developed by Chinese top vaccine researcher Chen Wei and Chinese biopharmaceutical company CanSinoBIO.
The phase 2 trial was randomized, double-blind and placebo-controlled trial conducted in a single center in Wuhan, Central China's Hubei Province. There were 508 volunteers over the age of 18 who participated in the trial, according to The Lancet report.
The vaccine induced seroconversion of the neutralizing antibodies in 59 percent and 47 percent of the participants, and seroconversion of binding antibody in 96 percent and 97 percent of participants, in the 1×10¹¹ and 5×10¹⁰ viral particles dose groups, respectively.
A single injection of the vaccine at 1×10¹¹ viral particles and 5×10¹⁰ viral particles induced comparable specific immune responses to the spike glycoprotein at day 28, with no significant differences noted between the two groups, according to the report.
No serious adverse events were documented within 28 days, the authors said.
This study is the first randomized controlled trial for evaluation of the immunogenicity and safety of a candidate non-replicating Ad5-vectored COVID-19 vaccine, the authors said.
Source: Global Times
