Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults

Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in HIV-infected Adults in China

Uptake, adherence, and completion of vaccination among HIV-infected adults were low, and their immune function and immune response to hepatitis B vaccination were also suboptimal, indicating that the current practice of hepatitis B vaccination can't protect HIV-infected adults from HBV infection. And the persistence of immunity induced by hepatitis B vaccination remains a challenge.

This is a randomized, open-label trial, conducted among HIV-infected adults with drug rehabilitation. This study will compare the immunogenicity, immune persistence, and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among HIV-infected adults.

Participants are randomized in a ratio of 1:1 into 20 µg recombinant hepatitis B vaccine group or 60µg recombinant hepatitis B vaccine group. The 20 µg group will receive three intramuscular injections of the 20 µg recombinant hepatitis B vaccine, while the 60 µg group will receive three intramuscular injections of the 60 µg dose at months 0, 1 and 6, respectively. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.

Inclusion Criteria:

• HIV-infected
• Aged between 18 and 70 years
• Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
• Willing to adhere to the study protocol

Exclusion Criteria:

• Being pregnant
• Acute cytolysis in the last three months before enrollment
• Any vaccination before or during the month preceding enrollment
• Any Intolerance or allergy to any component of the vaccine
• Ongoing opportunistic infection
• Hematological disorder
• Cancer
• Unexplained fever the week before enrollment
• Immunosuppressive or immunomodulating treatment in the last six months
• Liver disease