In individuals with HIV infection, a randomized clinical trial found that a high-dose hepatitis B virus (HBV) revaccination regimen was more effective than the standard-dose regimen. These results were published in JAMA Network Open.
The HBV Comparative Revaccination in HIV (CORE-HIV) study was conducted at a Hospital in Chile between 2013 and 2018. Adults (N=107) with HIV infection who were negative for HBV serologic markers after standard vaccination were recruited for this study. Participants were randomly assigned in a 1:1 fashion to receive a total of 3 doses of the HBV vaccine at either the high-dose regimen (40 mcg per dose) or standard-dose regimen (20 mcg per dose) at 0, 1, and 2 months. Participants in both the high-dose (n=52) and standard-dose (n=55) groups were assessed for serologic response up to 1 year after vaccination.
Study participants were 75.7% men with a mean age of 47 (standard deviation [SD], 13.3) years. In addition, 98.1% of participants were using antiretroviral therapy,86.0% had an undetectable HIV viral load, and the mean CD4 count was 418 (SD, 205) cells/mm3.
A serologic response was detected among 72.0% of partcipants in the high-dose group and 50.9% in the standard-dose group, indicating that the high-dose regimen was associated with an increased response rate (odds ratio [OR], 2.48; 95% CI, 1.02-6.10; P =.03).
Between weeks 4 and 8 following vaccination, Hepatitis B surface antibody (anti-HB) titers were 398.0 IU/L among the high-dose group and 158.5 IU/L among the standard-dose group (P <.001). High anti-HB titers (>100 IU/L) were observed among 80.6% and 50.0% of participants in the high- and standard-dose groups (P =.02), respectively.
At 1 year, a persistent serologic response (>10 IU/L) was observed among 80.0% of participants in the high-dose and 39.1% of those in the standard-dose groups (P =.01).
Injection-site reactions occurred among 2 participants, and no systematic reactions were reported.
This study may have been limited by the gender imbalance among the study participants.
These data indicated that the high-dose HBV vaccination regimen was associated with an increase in both efficacy and duration of protection among individuals with HIV infection who failed to respond to the standard-dose regimen, with most harboring protection up to 1 year after vaccination.
Vargas JI, Jensen D, Martínez F, et al. Comparative efficacy of a high-dose vs standard-dose hepatitis B revaccination schedule among patients with HIV: a randomized clinical mprial. JAMA Netw Open. 2021;4(8):e2120929. doi:10.1001/jamanetworkopen.2021.20929