Immunogenicity and safety of 4 intramuscular standard-dose and high-dose hepatitis B vaccine in people living with HIV: a randomized, parallel-controlled trial

Abstract

ABSTRACT Objectives The immunogenicity of hepatitis B vaccine is unsatisfactory in the people living with HIV (PLHIV). Studies evaluating optimal regimens to enhance immunogenicity have heretofore been inconclusive. The study was to compare the immunogenicity and safety of the four standard-dose and high-dose regimens of hepatitis B vaccine among PLHIV. Methods A randomized, parallel-controlled trial was conducted between May, 2020, and January, 2021. Patients were randomly assigned to receive 3 or 4 doses of 20 or 60 µg of hepatitis B vaccine. Seroconversion rate, high-level response rate, and geometric mean concentration (GMC) of antibody to hepatitis B surface antigen (anti-HBs) at weeks 12 and 28 were the main outcome measures. Results At week 28, the seroconversion rate and GMC of anti-HBs in both IM20 × 4 and IM60 × 4 groups were significantly higher than those in the IM20 × 3 group (P < 0.05), and the GMC of anti-HBs was numerically higher in the IM60 × 4 group than that in the IM20 × 4 group. Conclusions In PLHIV, both the four standard-dose and high-dose regimens significantly improved immunogenicity. The GMC of anti-HBs was numerically higher in the IM60 × 4 group than that in the IM20 × 4 group. Clinical trial registration ClinicalTrials.gov (NCT03962803)