People living with HIV don’t always respond to the vaccines used to prevent hepatitis B (their response range is 20-70 percent), even when given higher doses or more vaccinations. Immunologic protection is particularly important for people living with HIV because many have risk factors and are more likely to be susceptible to getting hepatitis B.
This international, multicenter open-label study (ACTG A5379) used three doses of a HepB-CpG vaccine that was designed to generate a stronger immune response (by adding the adjuvant – a compound meant to help activate the immune system – CpG 1018). This paper presents data on the antibody response in 68 people living with HIV with no history of hepatitis B vaccination and who attended all study visits as indicated in the protocol. Excitingly, 100 percent of participants achieved protective antibody levels after the three-dose series in the primary analysis. No unexpected safety issues were observed. This is better than responses seen in past studies of three-dose series of standard hepatitis B vaccines in people living with HIV. Interestingly, the vast majority of participants (>94 percent) already had strong immune responses after the second vaccine.
These data support the use of HepB-CpG as a primary vaccine series in this population and, if confirmed, will likely change the standard practice of which vaccine to use to protect people living with HIV from getting hepatitis B.
Ongoing studies are evaluating people living with HIV who have not responded to prior standard hepatitis B vaccination and evaluating if these antibodies persist over time. Future studies should evaluate people living with HIV who have lower CD4 T cells and people who inject drugs and also determine whether two vaccine doses might be enough.
Kristen M Marks et al., Immunogenicity and Safety of Hepatitis B Vaccine With a Toll-like Receptor 9 Agonist Adjuvant (HEPLISAV-B) in HBV Vaccine-naive People With Human Immunodeficiency Virus (HIV), Clinical Infectious Diseases, 2023;, ciad201, https://doi.org/10.1093/cid/ciad201