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On December 15th, Sanofi and GSK jointly announced that the clinical trial VAT0002 (n=521) of the recombinant adjuvant new crown vaccine co-developed by the two parties was positive and the initial results were positive.
After a single vaccination, it can produce a long-lasting immune response.
All subjects tested Regardless of the previous vaccination in the age group (including Modena, Pfizer/BioNTech, AstraZeneca, Johnson & Johnson's mRNA vaccine and non-mRNA vaccine), the level of neutralizing antibodies will increase by 9-43 times after vaccination with the recombinant adjuvant vaccine.
The safety and tolerability are similar to other new coronavirus vaccines that have been approved
.
VAT0002 is currently the most comprehensive booster test for different vaccines after inoculation, including the four most widely vaccinated early vaccinators.
4-10 months after the completion of the vaccination, they received 5μg of Sanofi/GSK recombinant adjuvant vaccine.
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VAT0002 test sites include multiple countries, including the United States, France, and the United Kingdom.
The ongoing randomized, double-blind, placebo-controlled phase 3 clinical trial VAT0008 (n>10000) is subject to regular review by the Independent Data Security Monitoring Board (DSMB).
During the last review, DSMB did not find any safety issues and suggested that the trial Continue until early 2022 to accumulate more data
.
Regulatory agencies require that the effectiveness of phase 3 clinical trials be demonstrated in the "naive" population, that is, adult subjects who have never been infected with the COVID-19 virus (seronegative) need to be included in two doses of 10μg on day 1 and day 22 Sanofi/GSK recombinant adjuvant vaccine
.
The 3 clinical trials enrolled the majority of subjects in the third quarter of 2021, and the number of COVID-19 virus infections caused by the Delta virus strain has increased significantly