World's First Inactivated COVID-19 Vaccine Produces Antibodies in All Participants in Clinical Trial
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By HospiMedica International staff writers Posted on 25 Jun 2020 |
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The world's first inactivated COVID-19 vaccine has produced antibodies in every participant in Phase I/II clinical trials, according to a news report by Science and Technology Daily.
The inactivated COVID-19 vaccine has been developed by the Wuhan Institute of Biological Products under the China National Biotec Group (CNBG) affiliated to the China National Pharmaceutical Group Co., Ltd. (Sinopharm Beijing, China). On April 12, the vaccine obtained the world's first clinical trial approval, and Phase I/II clinical trials were then launched for 66 consecutive days to obtain data on its safety and efficacy after administration of two injections. The study was designed to evaluate the safety and immunogenicity of the COVID-19 inactivated vaccine in healthy subjects aged from 18 to 59 for low, medium and high dosages and injections at intervals of 14, 21 and 28 days.
The study focused on the changes in cellular immunity after vaccination and explored vaccination procedures, immunization dosage, safety, immunogenicity and changes in antibody levels in vivo. Up to now, all the 1,120 subjects that took part in the Phase I/II clinical studies have completed two injections. The clinical trial results showed that the vaccination was safe without any serious adverse reaction, and after different procedures and different doses of vaccination were adopted, participants in the vaccine group all produced high titers of antibodies. For those aged 18-59 who received two medium-dose injections through the 14-day and 21-day interval procedures, they had a neutralizing antibody positive conversion rate of 97.6%. For those who received two medium-dose injections at an interval of 28 days, the neutralizing antibody positive conversion rate reached 100%. The CNBG is now actively developing overseas cooperation in the Phase III clinical research and has confirmed cooperative intentions with companies and institutions in various countries.
Related Links:
China National Pharmaceutical Group Co., Ltd.
The inactivated COVID-19 vaccine has been developed by the Wuhan Institute of Biological Products under the China National Biotec Group (CNBG) affiliated to the China National Pharmaceutical Group Co., Ltd. (Sinopharm Beijing, China). On April 12, the vaccine obtained the world's first clinical trial approval, and Phase I/II clinical trials were then launched for 66 consecutive days to obtain data on its safety and efficacy after administration of two injections. The study was designed to evaluate the safety and immunogenicity of the COVID-19 inactivated vaccine in healthy subjects aged from 18 to 59 for low, medium and high dosages and injections at intervals of 14, 21 and 28 days.
The study focused on the changes in cellular immunity after vaccination and explored vaccination procedures, immunization dosage, safety, immunogenicity and changes in antibody levels in vivo. Up to now, all the 1,120 subjects that took part in the Phase I/II clinical studies have completed two injections. The clinical trial results showed that the vaccination was safe without any serious adverse reaction, and after different procedures and different doses of vaccination were adopted, participants in the vaccine group all produced high titers of antibodies. For those aged 18-59 who received two medium-dose injections through the 14-day and 21-day interval procedures, they had a neutralizing antibody positive conversion rate of 97.6%. For those who received two medium-dose injections at an interval of 28 days, the neutralizing antibody positive conversion rate reached 100%. The CNBG is now actively developing overseas cooperation in the Phase III clinical research and has confirmed cooperative intentions with companies and institutions in various countries.
Related Links:
China National Pharmaceutical Group Co., Ltd.
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