New York—
Adults with HIV were fully protected by a three-dose course of the hepatitis B vaccine, HEPLISAV-B, even if they had never been vaccinated against or infected with the hepatitis B virus (HBV) in the past, according to a new study.

Weill Cornell Medicine–led researchers published their results in Open Forum Infectious Diseases after the study was a late-breaking presentation at ID Week this fall.

HBV, which is primarily spread through sexual contact and sharing of contaminated needles, causes a chronic infection which can lead to progressive liver disease. At the greatest risk are those living with HIV, including those who are taking antiretroviral therapy. In fact, 10% of HIV patients in the United States also have hepatitis B, according to the CDC.

The reason, according to the authors, is that HIV patients are less likely to produce a protective immunological response to HBV vaccination. While the HEPLISAV-B vaccine was approved in 2017 by the FDA as a two-dose vaccine regimen for adults, it was unclear if it offered fully protection to those with HIV.

The research team, which also was led by University of Cincinnati College of Medicine, tested a three-dose course of the vaccine in 68 adults living with HIV at 38 sites in the U.S., South Africa, and Thailand. None of the participants had received a previous HBV vaccination or had evidence of a previous HBV infection and all were on antiretroviral therapy.

After the initial dose of HEPLISAV-B vaccine 0.5 milliliters (mL) as an IM injection, study participants received additional doses at 4 weeks and 24 weeks.

The results indicated that all participants achieved seroprotection, with 88% of participants achieving Hepatitis B surface antigen levels greater than 1,000 mIU/mL. High antibody levels are considered to be an indication of long-term vaccine durability. “At 8 weeks after the second dose, 94.4% of participants achieved seroprotection; this percentage increased to 98.5% by week 24 prior to the third dose. The most common side effects related to vaccination were injection site pain, malaise, fatigue, muscle aches, and headaches,” the authors reported.

“In this study of PLWH with no history of HBV vaccination or evidence of prior HBV exposure, 100% seroprotection was achieved at 4 weeks after three doses of the HepB-CpG. No unexpected safety issues were observed,” the researchers concluded.

The international study will continue to examine the effects of two-dose HEPLISAV-B, as well as a three-dose regimen of another hepatitis B vaccine (ENGERIX-B, manufactured by GSK) among adult participants with HIV who were previously vaccinated against HBV but who did not achieve an adequate immunologic response. Final results could be available in 2023.

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