A non-inferiority trial comparing two recombinant vaccines (Hepa-B vs. Engerix-B) for hepatitis B among adults in Dhaka, Bangladesh

Vaccine. 2021 Sep 21:S0264-410X(21)01222-6. doi: 10.1016/j.vaccine.2021.09.031. Online ahead of print.ABSTRACTWorldwide Hepatitis B is known as one of the imperative causes of mortality and morbidity as well as occupational health hazard among health workers. Bangladesh is intermediate endemic country for Hepatitis B infection for which the government has introduced hepatitis B vaccination into the Expanded Programme on Immunization (EPI) nationwide since 2009 for new born children. However, the people who were born before 2009, was dependent on imported hepatitis B vaccine as there was no locally manufactured hepatitis B vaccine in Bangladesh. Hence, we conducted a randomized observer blinded non-inferiority clinical trial to assess the immunogenicity and safety of the locally manufactured Hepa-B vaccine in comparison with World Health Organization prequalified Engerix-B vaccine. Total 158 eligible adult participants were enrolled in this study with mean age of 30 and 29 years old in Hepa-B and Engerix-B groups, respectively. Both the vaccines were administered intramuscularly at 0, 1 and 6 months schedule. Baseline and post vaccination anti-HBs titers were measure at different time points. Seroconversion rate post three doses of Hepa-B vaccine was 98.67% similar to the comparator Engerix-B vaccine which was 100%. The geometric mean test ratios of both vaccines at all analysis time points were found > 0.5 predefined non-inferiority margin. Soreness at the injection site w...
Source: Vaccine - Category: Allergy & Immunology Authors: Source Type: research