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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Poststudy Point-of-Care Oral Fluid Testing in Human Immunodeficiency Virus-1 Vaccinees
Open Forum Infectious Diseases, Volume 8, No. 1, Article ofaa606, Year 2021
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Description
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. © 2020 The Author(s) 2020. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
Authors & Co-Authors
Yanosick, Katherine E.
United States, Boston
Beth Israel Deaconess Medical Center
Dragavon, Joan A.
United States, Seattle
University of Washington
Maenza, Janine R.
United States, Seattle
Fred Hutchinson Cancer Center
United States, Seattle
University of Washington
Espy, Nicole
United States, Seattle
Fred Hutchinson Cancer Center
Tomaka, Frank L.
Belgium, Beerse
Janssen Research & Development
Lavreys, Ludo
Unknown Affiliation
Allen, Mary Angie
United States, Bethesda
National Institute of Allergy and Infectious Diseases Niaid
D'Souza, M. Patricia
United States, Bethesda
National Institute of Allergy and Infectious Diseases Niaid
Hural, John A.
United States, Seattle
Fred Hutchinson Cancer Center
Coombs, Robert W.
United States, Seattle
University of Washington
Dolin, Raphael
United States, Boston
Beth Israel Deaconess Medical Center
United States, Boston
Harvard Medical School
Seaman, Michael S.
United States, Boston
Beth Israel Deaconess Medical Center
United States, Boston
Harvard Medical School
Walsh, Stephen R.
United States, Boston
Brigham and Women's Hospital
United States, Boston
Harvard Medical School
Baden, Lindsey Robert R.
United States, Boston
Brigham and Women's Hospital
United States, Boston
Harvard Medical School
Statistics
Citations: 2
Authors: 14
Affiliations: 10
Identifiers
Doi:
10.1093/ofid/ofaa606
ISSN:
23288957
Research Areas
Health System And Policy
Infectious Diseases