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Multicenter Study
. 2023 Aug 14;77(3):414-418.
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

Kristen M Marks  1 , Minhee Kang  2 , Triin Umbleja  2 , Anchalee Avihingsanon  3 , Patcharaphan Sugandhavesa  4 , Andrea L Cox  5 , Karen Vigil  6 , Hugo Perazzo  7 , Jennifer C Price  8 , Leolin Katsidzira  9 , Christina Vernon  10 , Beverly Alston-Smith  11 , Kenneth E Sherman  12 ; ACTG 5379 Study Team
Collaborators, Affiliations
Multicenter Study

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 et al. Clin Infect Dis. .

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.

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Conflict of interest statement

Potential conflicts of interest. K. M. M. has received research funding paid to her institution from Gilead Sciences. A. A. has received research grants from Gilead Sciences, GlaxoSmithKline, MSD, travel support for meetings from Gilead Science, and has received speaker honoraria from Gilead Sciences, ViiV Healthcare, and GlaxoSmithKline. K. J. V. has been a consultant to ViiV Healthcare, Theratechnologies, and Gilead Sciences and has research funding from Theratechnologies Inc. J. C. P. has had research support paid to her institution: Gilead Sciences, Merck, AbbVie, Zydus, Genentech, and Vir. K. E. S. has had research support paid to his institution from AbbVie, Abbott Laboratories, Gilead, BMS, Inovio, Merck, Zydus, Intercept, Helio and Astra Zeneca. He also reports royalities or licenses from UpToDate, consulting fees from Gilead, Theratechnologies, Axcella, MedPace, and Inovio (paid to author), stock or stock options from Exxon-Mobil, McDonalds, and Pepsico, and has served on DSMBs managed by Pliant, Horizon, ACI, Inovio, and MedPace. H. P. reports a grant from CNPq-Brazil (grant number 445957/2020-4) for an HCV treatment clinical trial. T. U. reports grants or contracts from NIH/NHLBI (REPRIEVE DCC grant number U01 HL23339), subcontract from KOWA Pharmaceutical via MGH in support of REPRIEVE-EU, and NIH/NIA subcontract from UC Denver (R01 AG054366). All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

Graphical Abstract
Graphical Abstract
This graphical abstract is also available at Tidbit: https://tidbitapp.io/tidbits/immunogenicity-and-safety-of-hepatitis-b-vaccine-with-a-toll-like-receptor-9-agonist-adjuvant-heplisav-b-in-hbv-vaccine-naive-people-with-hiv-652c25bd-d294-4915-93c8-8d48dcfa875b
Figure 1.
Figure 1.
Seroprotection response at study weeks: Percentages of participants with seroprotective titers ≥10 IU/mL (in blue) over the first 28 study w. HepB-CpG vaccine was prescribed at entry, week 4, and week 24. The figure depicts a snapshot of available date at each study week with N indicating the number of participants with data available at the study week. The LLQ and ULQ were 5 IU/mL and 1000 IU/mL, respectively. Abbreviations: Anti-HBs, hepatitis B surface antibody; LLQ, lower limit of quantification; HepB-CpG, Heplisav-B®; SPR, seroprotection response; ULQ, upper limit of quantification.
See this image and copyright information in PMC

References

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