Adjuvanted Hepatitis B vaccine (Recombinant)(Dynavax Technologies Corp.)

Data demonstrate superiority of HepB-CpG vaccination over conventional hepatitis B vaccines among people living with HIVLOS ANGELES, Dec. 03, 2024 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, today announced the publication of “HepB-CpG vs HepB Vaccine in People with HIV and Prior Vaccine Nonresponse: The BEe-HIVe Randomized Clinical Trial” in JAMA. The publication reports that two- and three-dose regimens of HepB-CpG vaccine provided superior protection compared to three doses of the conventional hepatitis B vaccine among people living with HIV who had previously not responded to the conventional vaccines. Hepatitis B is a leading cause of liver-related mortality worldwide resulting in more than 1 million deaths in 2022. It is a major cause of liver injury, cirrhosis, and liver cancer among people living with HIV, who often do not develop protective antibodies after receiving conventional hepatitis B vaccines. The HepB-CpG (HEPLISAV-B® [Hepatitis B Vaccine (Recombinant) Adjuvanted]) vaccine includes a TLR-9 agonist adjuvant (CpG 1018® adjuvant) and is known to achieve high protection against hepatitis B among people living with HIV, but until now there have been limited data about its protection among people living with HIV who had not responded to conventional hepatitis B vaccines. “These findings are tremendous news for people living with HIV who have struggled to achieve protection against hepatitis B,” said ACTG Chair Joseph J. Eron, M.D., University of North Carolina. “As a result of this data, the U.S. Department of Health and Human Services’ ‘Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents With HIV’ have been updated and clinical practice is already changing. Ultimately, we expect them to have an important impact on people living with HIV.” BEe-HIVe (B-Enhancement of HBV Vaccination in Persons Living With HIV, also known as A5379) was an international study evaluating the HepB-CpG vaccine among people living with HIV who were on antiretroviral therapy (ART) and had not responded to prior conventional hepatitis B vaccination and thus remained vulnerable to hepatitis B infection. This phase 3 randomized, open-label clinical trial included 561 people from 41 sites in 10 countries in Africa, Asia, North America, and South America. Study participants were equally randomized to one of three groups, receiving either: Two doses of HepB-CpG intramuscularly at week 0 and week 4Three doses of HepB-CpG intramuscularly at week 0, week 4, and week 24Three doses of HepB-alum (conventional hepatitis B vaccine) intramuscularly at week 0, week 4, and week 24 The primary analysis published in JAMA demonstrates that 99 percent of those receiving three doses of the HepB-CpG vaccine and 93 percent of those receiving two doses of the HepB-CpG vaccine achieved protection against hepatitis B compared to 81 percent receiving three doses of the conventional hepatitis B vaccine. The study demonstrates that the three-dose regimen of the HepB-CpG vaccine led to higher levels of protective antibodies, which may have long-term implications related to vaccine durability. Long-term protection results will be available in 2025. There were no unexpected safety concerns. “This study provides strong evidence that people living with HIV for whom prior hepatitis B vaccination was not successful should be re-vaccinated with the HepB-CpG vaccine to reduce their risk of future hepatitis B infection," said lead author and Protocol Co-Chair Kristen Marks, M.D., Weill Cornell Medicine. BEe-HIVe is led by Kenneth Sherman, M.D., Ph.D., University of Cincinnati and Massachusetts General Hospital (Protocol Chair) and Dr. Marks. ACTG is led by Dr. Eron and Rajesh T. Gandhi, M.D., Massachusetts General Hospital and Harvard Medical School (ACTG Vice-Chair). It is sponsored by the National Institute of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID, which also funds ACTG) under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634. HEPLISAV-B® was provided by Dynavax Technologies Corporation. For more information about BEe-HIVe, please visit clinicaltrials.gov. About ACTG ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve. Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH. Media Contact:Jenna Conley, ACTGjenna@conleycommunications.net