The 375 volunteers participating in the second phase of the Covivac vaccine trial will continue to receive the second dose starting from September 15 to 20.
Associate Professor, Dr. Vu Dinh Thiem, Director of the Clinical Trial Center, National Institute of Hygiene and Epidemiology, on the afternoon of September 13 said that the volunteers had injected a safe dose. Some common side effects after injection include fever, headache, fatigue, muscle pain, joint pain… Few nausea but have been medical care and recovered.
Covivac is a Covid-19 vaccine researched and developed by the Institute of Vaccines and Medical Biologicals (IVAC), which is a secondary vaccine with a course of two doses, 28 days apart. The vaccine is in phase two clinical trial on 375 people in three communes including Minh Lang, Viet Hung and Bach Thuan of Vu Thu district, Thai Binh province, starting from August 11. The volunteers were divided into three groups: 18-39 years old, 40-59 years old, and 60 years old and older. Each group is about 125 people, the ratio of men and women is relatively balanced.
According to the trial protocol, the second phase aims to further determine safety, partly immunogenicity, and find the optimal dose level for inclusion in a phase three trial. Currently, the vaccine is tested in two doses, including 3 mcg, 6 mcg and using the AstraZeneca vaccine as a control.
Dr. Duong Huu Thai, Director of the Institute of IVAC, said that the research team is also developing a phase three vaccine trial protocol. In particular, the group intends to carry out over 4,000 people in Khanh Hoa, Bac Ninh and Thai Binh provinces, compared with the licensed vaccine group, AstraZeneca. The third phase is expected to start in December this year.
“We are still consulting experts on the number of volunteers and the design of the phase three trial, but would like to keep the vaccine study design compared to a licensed vaccine,” said Dr. Thai said.
Covivac is the second potential Covid-19 vaccine candidate in Vietnam. The first Covid-19 vaccine candidate is Nanocovax, currently in phase three clinical trials, entering the mid-term review process for emergency authorization. The third candidate is ARCT-154, currently in a phase one clinical trial in Hanoi.