The domestically developed Covivac Covid-19 vaccine - PHOTO: VNA
HCMC - The second phase of clinical trials for the locally developed Covivac Covid-19 vaccine began in Vu Thu District, Thai Binh Province, today, August 10.
The Covivac vaccine, which is developed by the Nha Trang-based Institute of Vaccines and Medical Biologicals (IVAC), proved to be safe and effective against Covid-19 in the first phase of clinical trials, according to the Research Ethics Committee under the Ministry of Health.
Therefore, the ministry has approved the second phase of clinical trials for the vaccine.
The second phase has 375 volunteers divided into three groups. Members of the first group will each receive a 3-mcg dose of Covivac, while the second group will receive a 6-mcg dose each and the third will receive a dose of placebo.
Vu Dinh Thiem, director of the Clinical Trial Center under the National Institute of Hygiene and Epidemiology, said the volunteers, aged between 18 and up to 80, include people with chronic diseases such as diabetes and hypertension.
"If the second phase goes smoothly, the research team will collect blood samples from the volunteers 42 days after their first dose to evaluate the immunogenicity and neutralizing antibodies of the vaccine," he said.
On the 57th day after the first dose, the research team will conduct medical examinations and take blood samples from the volunteers for evaluation before the third phase of clinical trials can begin.
According to Dr. Duong Huu Thai, chairman of IVAC, the samples would also be sent to Canada for an independent evaluation.
Covivac is a viral vector vaccine, which is similar to the British-Swedish pharmaceutical company AstraZeneca’s Covid-19 vaccine, but uses a different cell substratum.
This is the second locally developed Covid-19 vaccine undergoing clinical trials, after Nanocovax produced by the HCMC-based Nanogen Pharmaceutical Biotechnology JSC.
Deputy Minister of Health Tran Van Thuan asked the research team to carry out the second phase of clinical trials for Covivac properly and efficiently.
The Health Ministry will assign an inspection team to monitor the process, ensuring the efficiency of the clinical trials and safety for the volunteers.
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