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Randomized Controlled Trial
. 2023 Aug 22;77(4):529-536.
doi: 10.1093/cid/ciad206.

A Randomized Clinical Trial of 1-Dose vs Accelerated 2-Dose Schedule for Hepatitis A Virus (HAV) Revaccination Among People With Human Immunodeficiency Virus Who Were Nonresponders or Had Seroreversion After Primary HAV Vaccination

Guan-Jhou Chen  1   2 , Hsin-Yun Sun  1 , Kuan-Yin Lin  1 , Szu-Min Hsieh  1 , Yu-Chung Chuang  1 , Wang-Da Liu  1   3 , Yu-Shan Huang  1 , Sung-Ching Pan  1 , Un-In Wu  1   3 , Aristine Cheng  1 , Yi-Chia Huang  4 , Cheng-Hsin Wu  1 , Yi-Ching Su  1 , Wen-Chun Liu  1 , Sui-Yuan Chang  5   6 , Chien-Ching Hung  1   7   8
Affiliations
Randomized Controlled Trial

A Randomized Clinical Trial of 1-Dose vs Accelerated 2-Dose Schedule for Hepatitis A Virus (HAV) Revaccination Among People With Human Immunodeficiency Virus Who Were Nonresponders or Had Seroreversion After Primary HAV Vaccination

Guan-Jhou Chen et al. Clin Infect Dis. .

Abstract

Background: For people with human immunodeficiency virus (PWH) who have no serological responses to their primary hepatitis A virus (HAV) vaccination or have seroreversion after successful primary vaccination, the optimal revaccination strategy remains unclear.

Methods: In this open-label, randomized clinical trial, PWH who tested negative for anti-HAV antibodies after receiving a standard 2-dose series of primary HAV vaccination were enrolled and assigned in a 1:1 ratio to receive either 1 dose (the 1-dose group) or 2 doses of HAV vaccine administered 4 weeks apart (the 2-dose group). Serological response rates and anti-HAV antibody titers were compared at weeks 24 and 48.

Results: Of the 153 participants (77 in the 1-dose group and 76 in the 2-dose group), the overall serological response rates at week 48 after revaccination were similar between the 2 groups (2- vs 1-dose, 80.2% vs 71.4%, P = .20). However, anti-HAV antibody titers were consistently higher in the 2-dose group than in the 1-dose group. In subgroup analysis, PWH who were nonresponders to primary HAV vaccination were significantly more likely to mount a serological response after 2-dose HAV revaccination (68.4% vs 44.1%, P = .038). No severe adverse events were reported throughout the study.

Conclusions: Two-dose HAV revaccination administered 4 weeks apart yielded similar serological responses as 1-dose revaccination among PWH who were nonresponders or had seroreversion after primary HAV vaccination. The 2-dose revaccination schedule generated significantly higher anti-HAV antibody titers and was more likely to elicit serological responses at week 48 among PWH who were nonresponders to primary HAV vaccination. Clinical Trials Registration. NCT03855176.

Keywords: fecal–oral transmission; immunization; men who have sex with men; outbreak; viral hepatitis.

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Conflict of interest statement

Potential conflicts of interest. C.-C. H. reports research support and speaker honoraria from Gilead Sciences and served on advisory boards for Gilead Sciences. H.-Y. S. reports research support from Gilead Sciences. All remaining authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

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