Comparative efficacy, safety and immunogenicity of Hepavax-Gene and Engerix-B, recombinant hepatitis B vaccines, in infants born to HBsAg and HBeAg positive mothers in Vietnam: an assessment at 2 years

Vaccine
Nguyen Trong HieuIvo Timmermans

Abstract

In a randomized, controlled trial, 105 healthy full-term infants born to HBsAg and HBeAg positive mothers received three doses (at 0, 1 and 6 months) of either a new recombinant hepatitis B vaccine (Hepavax-Gene) or Engerix-B. Both groups were also given hepatitis B specific Hepa-big immunoglobulin (HBIG) within 24h of birth. Levels of antibodies to hepatitis B surface antigen (anti-HBs) were assessed on days 30, 60, 210, 360, and 2 years post-vaccination. Efficacy and immunogenicity and safety of the two vaccines were not significantly different; both vaccines achieved >94% seroprotection within 360 days. At 2 years, only one subject (1.9%) in the Hepavax-Gene group and two subjects (3.9%) in the Engerix-B group were HBsAg positive. No serious adverse events (AEs) were observed in either group.

References

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Citations

Dec 5, 2002·Pharmacoepidemiology and Drug Safety
Feb 3, 2016·Human Vaccines & Immunotherapeutics·Yueyuan ZhaoPei Liu
Dec 22, 2007·Journal of Medical Virology·Dildora AvazovaMasashi Mizokami
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Apr 5, 2020·Vaccines·Ciying QianNingshao Xia
Apr 4, 2021·Vaccines·Aline Maria Vasconcelos QueirozMarcelo Sousa Silva
May 9, 2021·Vaccine·Cynthia Raissa Tamandjou TchuemSusan Cleary

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