HANOI (Aug 11): Vietnam’s second homegrown candidate vaccine Covivac began the second stage of clinical trials in the northern province of Thai Binh’s Vu Thu district on Aug 11 with the screening testing to choose qualified volunteers, reported VNA.
The screening testing will be conducted for six days, and the first jabs are expected to be given on August 18.
A total of 375 volunteers, chosen from 750 local residents in Vu Thu district, will be classified in three groups for the 3mcg and 6 mcg dosages and injections of vaccine AstraZeneca (instead of placebo infections in the first phase).
Earlier, assessing the first stage of Covivac human trials on over 120 volunteers since March 15, the National Ethics Committee in Biomedical Research under the Ministry of Health concluded that the vaccine was safe, well tolerated, immunogenic, and eligible for the second stage.
Covivac is a joint research between the Hanoi Medical University and the National Institute of Hygiene and Epidemiology (NIHE). It uses primary chicken embryo cell culture – a technique the institute used previously to successfully produce seasonal flu vaccines.
Associate Professor, Dr. Vu Dinh Thiem, director of the NIHE’s clinical trial centre, said that the selected volunteers must be over 18 years old, possibly up to 70-80 years old, including those with chronic diseases such as diabetes but under stable treatment.
If the second stage goes well, by the end of September, the research team will collect blood samples from the volunteers on the 42nd day after their first jabs to evaluate the vaccine’s immunogenicity.
On the 57th day, the volunteers will continue to undergo physical examination and take blood tests for evaluation and analysis before the team proposes the third stage of trials on 1,000 volunteers.
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