title: Immunogenicity and safety of hepatitis B vaccine (Shanvac-B) using a novel pre-filled single use injection device Uniject in Indian subjects.
abstract: BACKGROUND
  Hepatitis B is a major public health problem, which has now been controlled to some extent by vaccination especially with the recombinant hepatitis B vaccine, which has been proven to be safe and efficacious since its introduction in the 1990s. But problems of unsafe injection practices still persist. Now newer delivery devices like uniject are available for making vaccination very safe.
  
  
  OBJECTIVE
  To evaluate the immunogenicity and safety of the Hepatitis-B (Shanvac-B) vaccine in Uniject pre-filled device administered to healthy adults and infants at 0, 1, 2 months schedule.
  
  
  METHODS
  A total of 122 healthy subjects (62 adults and 60 infants) were administered three doses of the recombinant Hepatitis-B vaccine using Uniject pre-filled device. Blood samples for antibody titer estimation were taken before vaccination and 4-6 weeks after third dose. Subjects, parents or guardians were given diary cards to record any adverse reactions.
  
  
  RESULTS
  Protective immune responses to the vaccine were seen in 96.4% of adults and 100% of infants who completed the study. The Geometric Mean Titers (GMT) in adults and infants were 518.5 and 385.41 mIU/ml respectively. Mild fever, itching, and swelling at injection site were the most common side effects observed.
  
  
  CONCLUSIONS
  The safety and immunogenicity of the Hepatitis B Vaccine in the novel pre-filled device Uniject was effectively demonstrated in the present study.
authors.affiliation: Department of Gastroenterology, NIZAM's Institute of Medical Sciences, Hyderabad, India.
authors.forename: N
authors.initials: N
authors.lastname: Joshi
authors.forename: A
authors.initials: A
authors.lastname: Kumar
authors.forename: M B
authors.initials: MB
authors.lastname: Raghu
authors.forename: S
authors.initials: S
authors.lastname: Bhave
authors.forename: R
authors.initials: R
authors.lastname: Arulprakash
authors.forename: P
authors.initials: P
authors.lastname: Bhusari
authors.forename: Raman
authors.initials: R
authors.lastname: Rao
mesh_terms: D000293:Adolescent; D000328:Adult; D015331:Cohort Studies; D018562:Disease Transmission, Infectious / Q000517:prevention & control; D004349:Drug Packaging; D004869:Equipment Safety; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007194:India; D007231:Infant, Newborn; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D012680:Sensitivity and Specificity; D014611:Vaccination / Q000295:instrumentation* / Q000379:methods
chemical_list: D017325:Hepatitis B Vaccines