Evidence map›Paper›PMID 33511233›Full record

ArticleOpen forum infectious diseases2021

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 and 10 more

Open access · goldAbstract read
In one paragraph

Article in Open forum infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 43% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 8 institutions in 2 countries.

Karina OganezovaDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Elvin J Fontana-MartinezDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Jon A GothingDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Alisha PanditDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Esther KwaraMorehouse School of Medicine, Atlanta, Georgia, USA.
Katherine YanosickCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
Joan DragavonDepartment of Laboratory Medicine, University of Washington, Seattle, Washington, USA.
Erin A GoeckerDepartment of Laboratory Medicine, University of Washington, Seattle, Washington, USA.
Janine MaenzaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Nicole EspyVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Frank TomakaJanssen Pharmaceutical Research and Development, Titusville, New Jersey, USA.
Ludo LavreysJanssen Vaccines & Prevention, B.V., Leiden, The Netherlands.
Mary AllenNational Institute of Allergy and Infectious Diseases, Rockville, Maryland, USA.
Patricia D'SouzaNational Institute of Allergy and Infectious Diseases, Rockville, Maryland, USA.
John HuralVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Robert W CoombsDepartment of Laboratory Medicine, University of Washington, Seattle, Washington, USA.
Raphael DolinCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
Michael S SeamanCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
Stephen R WalshDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA.ORCID 0000-0002-0817-9370
Lindsey R BadenDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Brigham and Women's Hospital · USUniversity of Washington · USBeth Israel Deaconess Medical Center · USFred Hutch Cancer Center · USNational Institute of Allergy and Infectious Diseases · USJanssen (Netherlands) · NLJanssen (United States) · USMorehouse School of Medicine · US

Funding

LOC: HIV Vaccine Trials NetworkUM1AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Dan H. Barouch, Lawrence Corey · 2011 to 2026
$1175.6M
LC: HIV Vaccine Trials NetworkUM1AI068618 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Margaret Juliana McElrath · 2011 to 2026
$483.6M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI CONNIE L CELUM · 1988 to 2026
$104.9M
HARVARD CLINICAL AND TRANSLATIONAL SCIENCE CENTER (UL1)UL1RR025758 · NCRR · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2008 to 2011
$91.4M
Harvard Medical School Vaccine Clinical Trials UnitUM1AI069412 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI Lindsey Robert Baden, Daniel R. Kuritzkes · 2012 to 2026
$57.2M
NCRR NIH HHS UL1 RR025758NIAID NIH HHS P30 AI027757NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

backgroundExperimental 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.

methodsPlasma 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.

resultsFifty-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 (

conclusionsThese data suggest that this widely available patient-controlled test has limited reactivity to HIV-1 antibodies elicited by these candidate HIV-1 vaccines.

Indexed as

HIV diagnosticsHIV vaccineimmunogenicityvaccine safety

Identifiers

PMID33511233
PMCPMC7813203
OpenAlexW3111091492

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.