Three-dose series of adjuvanted hepatitis B vaccine is found safe and effective in PLWH

A three-dose series of an adjuvanted hepatitis B (HBV) vaccine, HepB-CpG (sold under the brand name Heplisav-B), achieved highly protective antibody levels in all participants of a small multi-center study involving people living with HIV (PLWH), with no unexpected safety concerns noted.

About This Study

“Immunogenicity and Safety of Hepatitis B vaccine with a Toll-like Receptor 9 Agonist Adjuvant (HEPLISAV-B) in HBV Vaccine-naive People with HIV” was published online on April 5, 2023, in Clinical Infectious Diseases. The lead author is Kristen M. Marks, M.D., of the Division of Infectious Diseases at Weill Cornell Medicine in New York, N.Y.

Key Research Findings

This prospective, open-label, international study among PLWH who had never been vaccinated against HBV evaluated the safety and effectiveness of a vaccine to which a toll-like receptor 9 agonist had been added. A two-dose series of that vaccine has been approved by the U.S. Food and Drug Administration for the general population. The study, which took place in 2020-2021, added a third dose to see whether this would extend the immune response among PLWH. Vaccine doses were administered at weeks 0, 4, and 24.

Sixty-five percent of the initial 74 study participants were in Thailand. Accordingly, 66% of participants were Asian, 16% were Black, and 15% were white. Binary sexes were roughly evenly represented, with 46% of participants identifying as men. The current analysis includes 68 participants; the remainder missed a visit or received a vaccine dose at the wrong time.

By week 24, after two doses of the study vaccine, 99% of participants had protective antibody levels in their blood. However, peak antibody levels were substantially higher four weeks after the third dose, indicating a potentially longer duration of protection.

Treatment-related adverse events were reported by 61% of participants, most commonly injection site pain, malaise, fatigue, myalgia, and headache. All such events resolved. Two serious adverse events, both involving mental health, were deemed unrelated to the treatment.

Discussion Highlights and Implications for Practice

Study limitations reported by the authors include the following, which they said limit the generalizability of these results to all PLWH:

• No participants were injecting drugs. (Needle sharing is a hepatitis B risk factor.)
• Median CD4 count was 625 cells/mm3. (Low CD4 count has been associated with reduced vaccine response in PLWH.)
• HIV was suppressed in 96% of participants. (HIV viremia has also been associated with reduced vaccine response in PLWH.)

Study participants will continue to be followed to determine when, and by how much, antibodies wane after the third dose, the authors wrote. Another study arm is ongoing, which involves PLWH who did not respond sufficiently to conventional HBV vaccination.

Study authors called for post-marketing studies to evaluate potential serious side effects.

By Barbara Jungwirth