Assessment of Embryo Fetal Developmental Toxicity Study of Hepatitis B (rDNA) Vaccine in Wistar Rats

Abstract

Hepatitis B infection is one of the most deadly diseases causing acute as well as chronic infection to liver which globally affects 5% of people worldwide. A recently developed Hepatitis B vaccine by recombinant DNA technology has been shown to be potentially efficacious in prevention of Hepatitis B virus (HBV) mediated infection. The purpose of current study was to detect the adverse effects of the vaccine on the pregnant female rats and developing embryo/fetus during organogenesis exposure. If any. In addition, anti-HBV antibodies in pregnant females were measured during the study. Three groups of 25 females injected intramuscularly Hepatitis B (rDNA) vaccine at the dose level of 0.25, 0.5 and 1.0 mL per animal once prior to cohabitation and once during gestation (day 10). Concurrent placebo control group was maintained to differentiate the effects of placebo from vaccine related effects. All females were mated to males of same stock with mating ratio of 2:1. The pregnant females were C-section about one day prior to delivery i.e. GD 20 to evaluate the uterine contents and the fetuses for external, visceral and skeletal anomalies. There was no abortion or death during the study. Expected local effects like mid swelling at injection site was observed which was attributed to common placebo related non-adverse effect. Gravimetric parameters did not reveal evidence of vaccine related toxicity. Pre natal parameters were comparable to control. There was no evidence of prenatal developmental toxicity and based on the results Hepatitis B (r-DNA) vaccine was not a teratogenic during the study. Immunogenicity profile showed measurable antibody titer that supports the use of the vaccine in the targeted human population.