240 people in Long An and 117 people in Hanoi received the first dose of Nanocovax in phase 2 of the trial.
Associate Professor, Dr. Chu Van Men, Director of the Center for Clinical Trials and Bioequivalence, Military Medical Academy, said that they are continuing to recruit and screen for phase two trial registrants, but along with vaccination to qualified volunteers participating in the trial.
Hanoi and Long An simultaneously vaccinated the testers for phase two from February 26. After 6 days, 357 people were injected, on average per day injected to 60 people in both regions. The research team did not report an unusual response from the volunteers after the injection.
Volunteers will receive two shots, each 28 days apart.
As planned, 560 people participated in the second phase trial in Hanoi and in Ben Luc district, Long An. Of these, 80 were given placebo injections, the remainder were evenly divided into the experimental groups of three injections of 25, 50 and 75 mcg. Thus, phase two still lacks 203 people vaccinated. Mr. Men said that without dividing the specific number of volunteers for two locations, vaccination and screening will take place until the number is enough as planned.
Volunteers were randomly given a vaccine or a placebo. Placebo is composed of many excipients, safe, does not affect the body. Purpose placebo injections to detect vaccine group differences and measure vaccine efficacy. In the second phase, experts will evaluate the immunogenicity and preventive efficacy of the vaccine Covid-19. At the end of the study, the placebo volunteers will receive a booster shot.
Nanocovax is vacicne Covid-19 produced and developed by Nanogen, the first Covid-19 vaccine in Vietnam to be tested in humans. The Nanocovax clinical trial process is expected to be completed by the end of 2021. Once licensed, Nanogen plans to provide the vaccine at VND 120,000 per dose, producing 50-70 million doses a year, with immediate guarantee. meet domestic demand, then export.
After Nanocovax, the Covivac vaccine studied by IVAC entered human trials. On March 5, IVAC will officially join the Hanoi Medical University to officially recruit volunteers for the research. And Vabiotech is the third research unit for Covid-19 vaccine, which has not submitted a clinical trial application.