Poststudy Point-of-Care Oral Fluid Testing in Human Immunodeficiency Virus-1 Vaccinees.

Autor: Oganezova K; Division of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA., Fontana-Martinez EJ; Division of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA., Gothing JA; Division of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA., Pandit A; Division of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA., Kwara E; Morehouse School of Medicine, Atlanta, Georgia, USA., Yanosick K; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA., Dragavon J; Department of Laboratory Medicine, University of Washington, Seattle, Washington, USA., Goecker EA; Department of Laboratory Medicine, University of Washington, Seattle, Washington, USA., Maenza J; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.; Department of Medicine, University of Washington, Seattle, Washington, USA., Espy N; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA., Tomaka F; Janssen Pharmaceutical Research and Development, Titusville, New Jersey, USA., Lavreys L; Janssen Vaccines & Prevention, B.V., Leiden, The Netherlands., Allen M; National Institute of Allergy and Infectious Diseases, Rockville, Maryland, USA., D'Souza P; National Institute of Allergy and Infectious Diseases, Rockville, Maryland, USA., Hural J; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA., Coombs RW; Department of Laboratory Medicine, University of Washington, Seattle, Washington, USA.; Department of Medicine, University of Washington, Seattle, Washington, USA., Dolin R; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.; Harvard Medical School, Boston, Massachusetts, USA., Seaman MS; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.; Harvard Medical School, Boston, Massachusetts, USA., Walsh SR; Division of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA.; Harvard Medical School, Boston, Massachusetts, USA., Baden LR; Division of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA.; Harvard Medical School, Boston, Massachusetts, USA.
Jazyk: angličtina
Zdroj: Open forum infectious diseases [Open Forum Infect Dis] 2020 Dec 15; Vol. 8 (1), pp. ofaa606. Date of Electronic Publication: 2020 Dec 15 (Print Publication: 2021).
DOI: 10.1093/ofid/ofaa606
Abstrakt: Background: Experimental human immunodeficiency virus (HIV)-1 vaccines frequently elicit antibodies against HIV-1 that may react with commonly used HIV diagnostic tests, a phenomenon known as vaccine-induced seropositivity/seroreactivity (VISP/VISR). We sought to determine, under clinic conditions, whether a patient-controlled HIV test, OraQuick ADVANCE Rapid HIV-1/2 Antibody Test, detected HIV-1 vaccine-induced antibodies.
Methods: Plasma assessment of HIV-1 cross-reactivity was examined in end-of-study samples from 57 healthy, HIV-uninfected participants who received a candidate vaccine that has entered Phase 2B and 3 testing. We also screened 120 healthy, HIV-uninfected, unblinded HIV-1 vaccine participants with VISP/VISR for an assessment using saliva. These participants came from 21 different parent vaccine protocols representing 17 different vaccine regimens, all of which contained an HIV-1 envelope immunogen. OraQuick ADVANCE was compared with results from concurrent blood samples using a series of commercial HIV screening immunoassays.
Results: Fifty-seven unique participant plasma samples were assayed in vitro, and only 1 (1.8%) was reactive by OraQuick ADVANCE. None of the 120 clinic participants (0%; 95% confidence interval, 0% to 3.7%) tested positive by OraQuick ADVANCE, and all were confirmed to be uninfected by HIV-1 viral ribonucleic acid testing. One hundred eighteen of the 120 (98.3%) participants had a reactive HIV test for VISP/VISR: 77 (64%) had at least 1 reactive fourth-generation HIV-1 diagnostic test ( P  < .0001 vs no reactive OraQuick ADVANCE results), and 41 (34%) only had a reactive test by the less specific third-generation Abbott Prism assay.
Conclusions: These data suggest that this widely available patient-controlled test has limited reactivity to HIV-1 antibodies elicited by these candidate HIV-1 vaccines.
(© The Author(s) 2020. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
Databáze: MEDLINE
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