Immunogenicity and Safety of Hepatitis B Virus (HBV) Vaccine With a Toll-Like Receptor 9 Agonist Adjuvant in HBV Vaccine-Naïve People With Human Immunodeficiency Virus
Kristen Marks, Minhee Kang, Triin Umbleja, Anchalee Avihingsanon, Patcharaphan Sugandhavesa, Andrea L. Cox, Karen J. Vigil, Hugo Perazzo, Jennifer C. Price, Leolin Katsidzira, Christina Vernon, Beverly Alston‐Smith, Kenneth E. Sherman, ACTG 5379 Study Team, Oladapo Alli, Ceora Beijer, Stephanie Caruso, M. Cermak, Shawn Chiambah, Lillian Collins, Kim Epperson, Françoise Giguel, Kevin Knowles, Jan Kosmyna, Michael Leonard, Philip Marzinek, Terence Mohammed, Sarah Zabih, Leonard Sowah, Randy Hyer
Abstract
In this international, multicenter open-label study (ACTG A5379) of HepB-CpG vaccine in people with human immunodeficiency virus (HIV) without prior hepatitis B virus (HBV) vaccination, all 68 participants achieved HBV seroprotective titers after the 3-dose series in the primary analysis. No unexpected safety issues were observed.