title: Clinical safety and efficacy of first indigenous recombinant hepatitis B vaccine.
abstract: A pilot study was conducted to assess the clinical safety and immunogenicity of an indigenously developed recombinant hepatitis B vaccine (Shanvac B) in 18 healthy adults. 20 microg of vaccine was administered at 0, 1 and 2 months. Protective anti HBs titres developed in 22%, 77% and 100% one month after 1st, 2nd and 3rd dose of vaccination, respectively. The geometric mean titre after the 3rd dose was 1015.29 mIu/ml. The vaccine was well tolerated with minor local and systemic side effects in 28% and 22%, respectively. The indigenously developed recombinant hepatitis B vaccine is safe, well tolerated and highly immunogenic.
authors.affiliation: Department of Gastroenterology, Nizam's Institute of Medical Sciences, Hyderabad.
authors.forename: A
authors.initials: A
authors.lastname: Kumar
authors.forename: N
authors.initials: N
authors.lastname: Joshi
authors.forename: D V
authors.initials: DV
authors.lastname: Sreenivas
authors.forename: S
authors.initials: S
authors.lastname: Palan
authors.forename: Y R
authors.initials: YR
authors.lastname: Nagarjuna Kumar
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D006510:Hepatitis B Antibodies / Q000096:biosynthesis* / Q000097:blood; D017325:Hepatitis B Vaccines / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D008297:Male; D010865:Pilot Projects; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology
chemical_list: D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D014614:Vaccines, Synthetic