Three-dose regimen of HEPLISAV-B vaccine fully protects people living with HIV, data shows

The AIDS Clinical Trials Group (ACTG), the world’s largest HIV research network whose focus has expanded to include evaluating outpatient treatment for COVID-19, today presented a session demonstrating that a three-dose regimen of the HEPLISAV-B vaccine fully protected people living with HIV at IDWeek 2022, taking place in Washington D.C. from October 19-22, 2022.

Hepatitis B is a serious liver infection that frequently affects people living with HIV. This study shows for the first time that people living with HIV with no history of hepatitis B infection or vaccination were fully protected by this vaccine. Our findings about the protection levels associated with HEPLISAV-B among people living with HIV are likely to change clinical practice and have a profound impact on people living with HIV around the world.”

Judith Currier, M.D., M.Sc., ACTG Chair, University of California, Los Angeles

The study, “High HBsAb seroprotection achieved 4 weeks after 3 doses of HepB-CpG vaccine in people living with HIV (PLWH) without prior HBV vaccination (ACTG A5379 Group B Preliminary Results)” takes place on Thursday, October 20, 2022, during the “Late-Breaking Vaccine Studies” session from 1:45-3:00 p.m. E.T., led by study chairs Kenneth Sherman M.D., University of Cincinnati College of Medicine, and Kristen Marks, M.D., Weill Cornell Medicine. ACTG 5379 is an ongoing, prospective, open-label study to evaluate the level of seroprotection provided by HEPLISAV-B for people living with HIV.

This analysis included 68 people living with HIV who had not received a hepatitis B vaccine and showed no evidence of prior hepatitis B exposure. Participants were on antiretroviral therapy with CD4>100 cells/mm3 and HIV-1 RNA<1000 copies/mL. Participants received three doses of HEPLISAV-B (at weeks 0, 4, and 24) and achieved 100 percent seroprotection. No unexpected safety issues were observed.

Participants enrolled at 13 global sites in the U.S., Thailand, and South Africa. Among them, 46 percent were male, 66 percent were Asian, 16 percent were Black, and 15 percent were white. The median age was 47.

The Food and Drug Administration (FDA) approved the HEPLISAV-B vaccine in 2017 as a two-dose regimen for adults, but until now, there has been little data around its use among people living with HIV.