Hanoi (VNA) - Vietnam’s second homegrown Covivac candidate vaccine will begin the second stage of clinical trials in the northern province of Thai Binh’s Vu Thu district on August 10.
A total of 375 volunteers will be classified in three groups for the 3mcg and 6 mcg dosages and placebo injections.
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 has been developed and produced by the Institute of Vaccines and Medical Biologicals (IVAC). 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 center, 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, hypertension 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./.
A total of 375 volunteers will be classified in three groups for the 3mcg and 6 mcg dosages and placebo injections.
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 has been developed and produced by the Institute of Vaccines and Medical Biologicals (IVAC). 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 center, 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, hypertension 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./.
VNA