The world’s first, China’s new crown inactivated vaccine Phase I/II study unblind: antibody positive conversion rate of 100%

Chinese companies not only have the largest number of vaccines in the world in the development of new coronavirus vaccines, but they have also made a crucial step in the effectiveness of vaccines.

At today’s unblind meeting for phase I/II clinical trials of the new coronavirus inactivated vaccine, the domestic vaccine was highly praised, and the positive conversion rate of two injections was 100%.

According to a state-owned Xiaoxin report, on June 16, the blind review and staged unblinding meeting of the Phase I/II clinical trial of the new coronavirus inactivated vaccine developed by the Wuhan Institute of Biological Products of Sinopharm was held in Beijing and Henan simultaneously. .

The Wuhan Institute of Biological Products’ clinical trial of the inactivated vaccine for the new crown is a randomized, double-blind, placebo-controlled phase I/II clinical trial. On April 12, the new crown inactivated vaccine was the first company in the world to obtain a clinical trial approval. Phase I/II clinical trials were simultaneously launched in Wuzhi County, Henan Province.

This clinical trial has been struggling for 66 consecutive days, and it is the world’s first to obtain the safety and effectiveness data of the new crown inactivated vaccine after 2 injections. The research results of different ages, different procedures, different doses, and different injection times have been compared. Complete presentation.

This is also the longest time, the most comprehensive data, and the most effective clinical research results of the new crown vaccine so far, providing scientific and evaluable data for my country’s epidemic prevention and control and emergency use.

This study aims to evaluate the safety and immunogen of the new crown inactivated vaccine in healthy subjects aged 18-59 years after vaccination according to low, medium and high doses and different procedures of 0,14, 0,21 and 0,28 It focuses on the changes in cellular immunity after vaccination, and explores the changing trends of vaccination procedures, immunization doses, safety, immunogenicity, and antibody levels in the body.

Up to now, there are 1120 subjects in Phase I/II clinical research, and all of them have completed 2 doses of vaccination.

The most worth mentioning is that the clinical trial program was carefully designed, and the unblinding process strictly followed the scientific and rigorous results, and the results were exciting.

The vaccine is safe and effective after vaccination. All subjects in the vaccination group produced high-titer antibodies. The intermediate dose of the 18-59 year-old group followed the procedure of 0,14 and 0,21 days after two doses. The positive conversion rate of neutralizing antibodies reached 97.6. %, according to the procedure of 0,28 days, the positive conversion rate of two doses of neutralizing antibody is 100%.

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