A randomized clinical trial of one-dose versus accelerated two-dose schedule for hepatitis A virus revaccination among people with HIV who were non-responders or had seroreversion after primary HAV vaccination.

Abstract

For people with HIV (PWH) who have no serological responses to their primary hepatitis A virus (HAV) vaccination or have seroreversion after successful primary vaccination, optimal revaccination strategy remains unclear. 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 one dose (the one-dose group) or two doses of HAV vaccine administered four weeks apart (the two-dose group). Serological response rates and the anti-HAV antibody titers at weeks 24 and 48 were compared. Of the 153 participants (77 in the one-dose group and 76 the two-dose group), the overall serological response rates at week 48 after revaccination were not statistically significantly different between the two groups (two- vs. one-dose, 80.2% vs. 71.4%, p=0.20). However, anti-HAV antibody titers were consistently higher in the two-dose group than the one-dose group. In subgroup analysis, PWH who were non-responders to their primary HAV vaccination were significantly more likely to mount a serological response after two-dose HAV revaccination (68.4% vs. 44.1%, p=0.038). No severe adverse effects were reported throughout the study. Two-doses HAV revaccination administered four weeks apart yielded similar serological responses as one-dose revaccination among PWH who were non-responders or had seroreversion after primary HAV vaccination. Two-dose revaccination schedule generated significantly higher anti-HAV antibody titers and were more likely to elicit serological responses at week 48 among PWH who were non-responders to primary HAV vaccination.