AI Article Synopsis

  • Hepatitis B vaccination has been improved by the use of recombinant vaccines since the 1990s, although unsafe injection practices remain a concern, prompting the development of safer delivery devices like Uniject.
  • This study evaluated the immunogenicity and safety of the Shanvac-B hepatitis B vaccine administered through the Uniject device in 122 healthy adults and infants over a 0, 1, 2-month schedule.
  • Results showed that 96.4% of adults and 100% of infants developed protective immune responses, with mild side effects like fever and itching reported, confirming the vaccine's safety and efficacy with the new delivery system.

Article 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.

Conclusion: The safety and immunogenicity of the Hepatitis B Vaccine in the novel pre-filled device Uniject was effectively demonstrated in the present study.

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