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

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)

KEYWORDS:

• Hepatitis B vaccination
• immunogenicity
• people living with HIV
• randomized controlled trial
• safety

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

Y Feng: conceptualization, conceived and designed the study, investigated and performed experiments, reviewed and interpreted data, wrote the manuscript. Z Chen: analyzed the data, reviewed and interpreted data. R Xie, T Yao, Y Wu, F Yang, C Yuan, X Nie: investigated and performed experiments. F Wang: conceptualization of manuscript, writing-review & editing. X Liang* & S Wang*: conceptualization, conceived and designed the study, reviewed and interpreted data, writing-review & editing.

Additional information

Funding

This paper was funded by The National Science and Technology Major Project of the Ministry of Science and Technology of the People’s Republic of China (2018ZX10721202).