Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
The primary aim of this open-label, randomized control trial is to compare the immunogenicity
at week 28 after 20µg HBV vaccine (at week 0, 4, 24) versus 40µg HBV vaccine (40-µg at week
0, 4, 24 week) among HIV-positive patients or HIV-negative MSM who were born in Taiwan after
July 1986 and tested negative for all HBV serological markers. The secondary aims are to
assess the safety of double-dose HBV vaccination, the proportions of high-level responders
(anti-HBs antibody >100 mIU/ml) at weeks 28 and 48, the serological responses at week 48, and
incident HBV infection (indicated by appearance of anti-HBc and/or HBsAg) at week 48.