In the research and development of new Crown virus vaccine, Chinese companies not only have the largest number in the world, now the vaccine effect has also achieved a key step-today’s Phase I/II clinical trial of the new coronavirus inactivated vaccine has been highly praised, with a two-needle positive transfer rate of 100%. According to state-owned small new reports, on June 16, the Phase I/II clinical trial blind review and stage unblinding meeting of the new Crown virus inactivated vaccine developed by the China biological Wuhan Institute of Biological Products of Sinopharm Group was held simultaneously in Beijing and Henan.
The clinical trial of the new Crown inactivated vaccine of Wuhan Institute of Biological Products is a randomized, double-blind, placebo-controlled Phase I/II clinical study. On April 12, the new Crown inactivated vaccine was the first in the world to obtain a clinical trial approval document, and the phase I/II clinical trial was launched simultaneously in Wuzhi county, Henan province.
This clinical trial has been fighting for 66 consecutive days, for the first time in the world, the safety and effectiveness data of the new Crown inactivated vaccine after 2-needle inoculation have been obtained, and the research results of different ages, different procedures, different doses and different needle times have been obtained, all have relatively complete presentation.
This is by far the longest, the most comprehensive data, the most ideal effect of the new Crown vaccine clinical research results, for China’s epidemic prevention and control and emergency use to provide scientific and evaluable data.
The purpose of this study is to evaluate the safety and immunogenicity of the new Crown inactivated vaccine in healthy subjects aged 18-59 years after inoculation according to low, medium and high doses and different procedures of 0,14, 0,21 and 0,28, focus on the changes of cellular immunity after vaccination, and explore the change trend of immune program, immune dose, safety, immunogenicity and antibody level in vivo.
Up to now, a total of 1120 subjects in Phase I/II clinical studies have completed 2 injections.
The clinical trial scheme has been carefully designed, and the process of uncovering the blind strictly follows the scientificity and preciseness. The results are encouraging, and it is safe and effective after vaccination. The subjects in the vaccinated group all produce high titer antibodies, in the 18-59-year-old group, the neutralizing antibody positive conversion rate reached 0,14 after inoculation according to the 0,21-Day and 97.6%-day procedures, and the neutralizing antibody positive conversion rate reached 0,28 after inoculation according to the 100%-day procedures.