Duration of immunogenicity of four triple doses and four standard doses hepatitis B vaccine in adults infected with human immunodeficiency virus: A one-year follow-up study in China.

Abstract

Background: People infected with human immunodeficiency virus (HIV) are more likely to be infected with hepatitis B virus (HBV), which is a significant public health concern. It is essential to provide protection through the hepatitis B vaccine and to stimulate higher and more sustained levels of anti-HBs antibodies to ensure long-term immunity. We aimed to enhance the duration of immunogenicity by implementing high-dose and multiple-schedule hepatitis B vaccination in adults infected with HIV.

Methods: This open-label, parallel-group, randomised controlled trial (RCT) was conducted between May 2020 and January 2021 at the Second Hospital of Yuncheng. Patients were randomised to receive 3 or 4 doses of 20 μg or 60 μg of hepatitis B vaccine. The follow-up period was extended to 2022 to evaluate the duration of immunogenicity.

Results: The geometric mean concentration (GMC) and response rates of hepatitis B surface antibody (anti-HBs) at month 18 were 200.40 mIU/ml and 66.67 % (58/87) in the IM20 × 3 group, 382.20 mIU/ml and 75.58 % (65/86) in the IM20 × 4 group, 628.50 mIU/ml and 83.13 % (69/83) in the IM60 × 4 group, which were significantly different between the IM20 × 3 and IM60 × 4 groups (P < 0.017). In multivariate analysis, gender and vaccination regimens affected the duration of immunogenicity at month 18. Regarding the multiplicative scale, the interaction effect was significant between the male and the IM60 × 4 group after adjusting for confounders.

Conclusion: In the one-year follow-up (month 18) of adults infected with HIV, four triple doses regimen of hepatitis B vaccine improved the duration of immunogenicity in male patients.