The Covivac first stage clinical trial has recruited volunteers aged 18-39 years old, and there is a shortage of volunteers aged 40-59 years.
Exchange with VnExpress, Associate Professor, Dr. Vu Dinh Them, Director of the Center for Clinical Trial, National Institute of Hygiene and Epidemiology, said that the first phase of Covivac vaccine clinical trial needed 120 volunteers to participate. They divided into 4 groups according to age and sex. Each group of 30 people, including females aged 18-39, males aged 18-39, females aged 40-59, and males aged 40-59.
Three days after the announcement of the recruitment of volunteers, hundreds of volunteers aged 18-39 have registered, now fully selected to join this group. For the age group 40-59, there are only 19 women and 33 males registered. Thus, this group needs about 40 more women and 35 men, living in the inner districts of Hanoi, to register.
According to Dr. Thieu, the number of registrars is 2-3 times more than the need. They will participate in the screening according to 6 selection criteria and 21 exclusion criteria, newly recruiting the appropriate and necessary number of volunteers. The higher the age of the volunteer, the higher the screening failure rate is.
The team of scientists decided to choose volunteers living in Hanoi to facilitate travel and monitor safety after injection.
As planned, volunteers will stay at the study site for 24 hours after vaccination to be monitored, recorded and managed if any side effects occur. In addition, volunteers were examined 9 times within 13 months of participating in the trial. In particular, the first visit is to screen volunteers who are eligible to participate. They were given blood samples 7 times, including before injection and 7 days after each injection, 14 days, 6 months, 12 months after the second injection. This monitoring process aims to evaluate health and measure the amount of antibodies in the blood, ensuring healthy volunteers.
Volunteers, after passing the preliminary screening questions, will be enrolled in phase one research. This phase aims to initially assess the safety and immunogenicity of four different vaccine formulations to select the best two, and continue to be included in the second phase of the clinical trial. After phase two, the research team will choose the optimal formula for phase three. The optimal vaccine formulation must meet safety, immunogenicity, and cost and production capacity.
“The vaccine has been developed in the laboratory and then successfully tested in the animals, but if the vaccine is not proven in clinical trials, it will never fail,” said Dr. Thieu. Now come to life, contributing to disease prevention “.
Therefore, volunteers participating in vaccine clinical trials are to help scientists gather scientific evidence, prove the safety and preventability of a new vaccine.
Covivac is a Covid-19 vaccine researched and developed by the Institute of Vaccines and Medical Biologicals (IVAC) and put into a first-stage clinical trial with doses including 1 mcg, 3 mcg, 10 mcg, and 1 mcg. adjuvant and placebo group. Those who want to participate in the trial can register via website, email, call or directly at the Center of Clinical Pharmacology, Hanoi Medical University.