NCT03316807

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Suping Wang · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatitis B Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	60 µg dose hepatitis B vaccine	three-dose, 60 µg per dose
BIOLOGICAL	20 µg dose hepatitis B vaccine	three-dose, 20 µg per dose

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-07-01
• Completion: 2018-07-01
• First posted: 2017-10-20
• Last updated: 2022-03-11
• Results posted: 2021-01-14