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China's Phase I/II Clinical Trial of Inactivated COVID-19 Vaccine Reveals: 100% Seropositivity Rate for Neutralizing Antibodies
Release date:
2020-06-17
Source: Sina Pharmaceutical News 2020-06-16 A-A+
On June 16, the Phase I/II clinical trial blind review and interim unblinding ceremony for the inactivated COVID-19 vaccine developed by the Wuhan Institute of Biological Products, China National Biotec Group (CNBG), was held simultaneously in Beijing and Henan Province.
Blindness-unmasking results show:
Vaccination demonstrated excellent safety, with no serious adverse reactions reported. After receiving different regimens and doses, all participants in the vaccine group developed high-titer antibodies. Specifically, following a 0-28-day schedule of two-dose administration, the seroconversion rate for neutralizing antibodies reached 100%.
This COVID-19 inactivated vaccine clinical trial conducted by the Wuhan Institute of Biological Products is a randomized, double-blind, placebo-controlled Phase I/II study. On April 12, the vaccine became the world's first to receive approval for clinical trials, and the Phase I/II clinical trial was simultaneously launched in Wuzhi County, Henan Province.
This study aimed to evaluate the safety and immunogenicity of an inactivated COVID-19 vaccine in healthy participants aged 18–59, administered at low, medium, and high doses according to different schedules—0, 14, 0, 21, and 0, 28 days apart. The research placed particular emphasis on changes in cellular immunity following vaccination, while also exploring optimal vaccination regimens, immunization dosages, safety profiles, immunogenicity, and trends in circulating antibody levels within the body. As of now, a total of 1,120 participants have completed the two-dose vaccination regimen in the Phase I/II clinical trial.
The clinical trial protocol was meticulously designed, and the unblinding process strictly adhered to scientific rigor and meticulousness. The results were truly encouraging: the vaccine proved safe and highly effective after administration. All participants in the vaccinated group developed high-titer antibodies. Specifically, in the 18-59 age group, administering two doses according to the 0/14-day or 0/21-day schedule achieved a neutralizing antibody seroconversion rate of 97.6%, while following the 0/28-day schedule resulted in a 100% seroconversion rate for neutralizing antibodies.
Meanwhile, China Biologics is also advancing Phase III clinical trials through overseas collaborations, having already secured letters of intent with companies and institutions in multiple countries. Notably, China Biologics has taken the lead in establishing a production facility with an exceptionally high biosafety level—currently the world's only COVID-19 vaccine production plant that meets both biosafety and GMP standards and can, in terms of capacity, fully support urgent vaccination needs.
Statement: This article is written by a contributor to Sina Medicine News, and the views expressed herein solely represent the author's own opinions and do not reflect the position of Sina Medicine News.
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