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 M Marks; Minhee Kang; Triin Umbleja; Anchalee Avihingsanon; Patcharaphan Sugandhavesa; Andrea L Cox; Karen Vigil; Hugo Perazzo; Jennifer C Price; Leolin Katsidzira; Christina Vernon; Beverly Alston-Smith; Kenneth E Sherman; ACTG 5379 Study Team

doi:10.1093/cid/ciad201

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

Clin Infect Dis. 2023 Aug 14;77(3):414-418. doi: 10.1093/cid/ciad201.

Collaborators

ACTG 5379 Study Team:
Oladapo Alli, Ceora Beijer, Stephanie Caruso, Mary Allegra Cermak, Shawn Chiambah, Lillian Collins, Kim Epperson, Francoise Giguel, Kevin Knowles, Jan Kosmyna, Michael Leonard, Philip Marzinek, Terence Mohammed, Sarah Zabih, Leonard Sowah, Randy Hyer

Affiliations

¹ Division of Infectious Diseases, Weill Cornell Medicine, New York, New York, USA.
² Center for Biostatistics in AIDS Research in the Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
³ HIV-NAT, Thai Red Cross AIDS Research Centre and CE in Tuberculosis, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
⁴ Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand.
⁵ Division of Infectious Diseases, Johns Hopkins University, Baltimore, Maryland, USA.
⁶ Division of Infectious Diseases, McGovern Medical School, University of Texas, Houston, Texas, USA.
⁷ Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, Brazil.
⁸ Division of Gastroenterology and Hepatology, Department of Medicine, University of California San Francisco, San Francisco, California, USA.
⁹ Internal Medicine Unit, Faculty of Medicine and Health Sciences, University of Zimbabwe, Harare, Zimbabwe.
¹⁰ DLH Corporation, Silver Spring, Maryland, USA.
¹¹ Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
¹² Division of Digestive Diseases, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.

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.

Keywords: HIV; HepB-CpG; Heplisav-B; hepatitis B; vaccine.

Publication types

Multicenter Study
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Adjuvants, Immunologic / adverse effects
HIV
Hepatitis B Antibodies
Hepatitis B Surface Antigens
Hepatitis B Vaccines / adverse effects
Hepatitis B virus*
Hepatitis B* / prevention & control
Humans
Toll-Like Receptor 9 / agonists

Substances

Toll-Like Receptor 9
Hepatitis B Vaccines
Adjuvants, Immunologic
Hepatitis B Antibodies
Hepatitis B Surface Antigens

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

Authors

Collaborators

Affiliations

Abstract

Publication types

MeSH terms

Substances

Grants and funding