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

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. As no specific treatment is available, greatest emphasis is placed on prevention through immunization. Hepatitis B virus (HBV), a member of the hepadnaviridae family, is an envelope, circular, single-stranded, and partially doublestranded DNA virus [1-3]. The virus interferes with the functions of the liver while replicating in hepatocytes. A recently developed Hepatitis B vaccine is produced by r-DNA technology where Hansunela Polymorpha cells containing gene for Hepatitis B surface antigen are grown to achieve maximum growth and then lysed to recover recombinant protein. It is being further purified, where it form like noninfectious virus-like particles (VLPs) which are immunogenic. They are formulated with alum hydroxide as final vaccine in liquid form. The safety of the Hepatitis B (r-DNA) vaccine has been evaluated in nonclinical and clinical studies.