Evaluation of the safety and immunogenicity of recombinant DNA hepatitis B vaccine (RecomBvax) producted by VABIOTECH

ABSTRACT

Recombinant DNA hepatitis B vaccine (RecomBvax)- produced by VABIOTECH -National Institute of Hygiene and Epidemiology was injected into 319 children from 3 to 6 years old living in 3 communes Thieu Long, Thieu Hung and Thieu Hop of Thieu Hoa district, Thanh Hoa province to evaluate quality of the vaccine in clinical. The results showed that RecomBvax vaccine have high safety and have not significant side effect. The incidence of positive immune response of 3 RecomBvax injections is 91,85% with GMT of 350.6mIU/ml while the protective concentration of antibody needed is 10mIU/ml. RecomBvax is highly safe and immunogenic response equivalent with rHbvax in the control group.