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

Karina Oganezova; Elvin J Fontana-Martinez; Jon A Gothing; Alisha Pandit; Esther Kwara; Katherine Yanosick; Joan Dragavon; Erin A Goecker; Janine Maenza; Nicole Espy; Frank Tomaka; Ludo Lavreys; Mary Allen; Patricia D'Souza; John Hural; Robert W Coombs; Raphael Dolin; Michael S Seaman; Stephen R Walsh; Lindsey R Baden

doi:10.1093/ofid/ofaa606

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

Open Forum Infect Dis. 2020 Dec 15;8(1):ofaa606. doi: 10.1093/ofid/ofaa606. eCollection 2021 Jan.

Authors

Karina Oganezova¹, Elvin J Fontana-Martinez¹, Jon A Gothing¹, Alisha Pandit¹, Esther Kwara², Katherine Yanosick³, Joan Dragavon⁴, Erin A Goecker⁴, Janine Maenza^{5

6}, Nicole Espy⁵, Frank Tomaka⁷, Ludo Lavreys⁸, Mary Allen⁹, Patricia D'Souza⁹, John Hural⁵, Robert W Coombs^{4

6}, Raphael Dolin^{3

10}, Michael S Seaman^{3

10}, Stephen R Walsh^{1

10}, Lindsey R Baden^{1

10}

Affiliations

¹ Division of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA.
² Morehouse School of Medicine, Atlanta, Georgia, USA.
³ Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
⁴ Department of Laboratory Medicine, University of Washington, Seattle, Washington, USA.
⁵ Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
⁶ Department of Medicine, University of Washington, Seattle, Washington, USA.
⁷ Janssen Pharmaceutical Research and Development, Titusville, New Jersey, USA.
⁸ Janssen Vaccines & Prevention, B.V., Leiden, The Netherlands.
⁹ National Institute of Allergy and Infectious Diseases, Rockville, Maryland, USA.
¹⁰ Harvard Medical School, Boston, Massachusetts, USA.

Abstract

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.

Keywords: HIV diagnostics; HIV vaccine; immunogenicity; vaccine safety.

Abstract

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