Evidence map›Paper›PMID 39441137›Full record

ArticleThe Journal of infectious diseases2025

Evaluation and Real-world Experience of a Neutralization Susceptibility Screening Assay for Broadly Neutralizing Anti-HIV-1 Antibodies.

Marie Høst Pahus, Yu Zheng, Maxine Olefsky, Jesper Damsgaard Gunst, Pablo Tebas, Babafemi Taiwo, Ole S Søgaard, Michael J Peluso, Yolanda Lie, Jacqueline D Reeves and 3 more

Abstract readEvaluation Study
In one paragraph

Article in The Journal of infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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

7 citing papers in PubMed.

  1. Phase 2 Trial of Long-Acting Cabotegravir and VRC07-523LS for Viral Suppression in Adults With HIV-1: ACTG A5357.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Trial
  2. Article
  3. Article
  4. Review
  5. Review
  6. Observational
  7. Future of bNAbs in HIV Treatment.Current HIV/AIDS reports · 2025
    Review
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

13 authors.

Marie Høst PahusDepartment of Infectious Diseases, Aarhus University Hospital, Denmark.
Yu ZhengChan School of Public Health, Harvard University, Boston, Massachusetts.
Maxine OlefskyChan School of Public Health, Harvard University, Boston, Massachusetts.
Jesper Damsgaard GunstDepartment of Infectious Diseases, Aarhus University Hospital, Denmark.
Pablo TebasDivision of Infectious Disease, Department of Medicine, University of Pennsylvania, Philadelphia.ORCID 0000-0001-5345-7942
Babafemi TaiwoDivision of Infectious Disease, Department of Medicine, Northwestern University, Chicago, Illinois.
Ole S SøgaardDepartment of Infectious Diseases, Aarhus University Hospital, Denmark.
Michael J PelusoDivision of HIV, Infectious Diseases and Global Medicine, Department of Medicine, University of California San Francisco.
Yolanda LieLabcorp-Monogram Biosciences, South San Francisco, California.
Jacqueline D ReevesLabcorp-Monogram Biosciences, South San Francisco, California.
Christos J PetropoulosLabcorp-Monogram Biosciences, South San Francisco, California.
Marina CaskeyDepartment of Clinical Investigation, Rockefeller University, New York City, New York.
Katharine J BarDivision of Infectious Disease, Department of Medicine, University of Pennsylvania, Philadelphia.ORCID 0000-0002-9773-0071

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
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
Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI DAVID S METZGER · 1999 to 2026
$78.6M
Weill Cornell Medicine - Rutgers New Jersey Medical School Clinical Trials UnitUM1AI069419 · NIAID · WEILL MEDICAL COLL OF CORNELL UNIV · PI ROY M. GULICK · 2012 to 2026
$44.6M
BEAT-HIV: Delaney Collaboratory to Cure HIV-1 Infection by Combination ImmunotherapyUM1AI164570 · NIAID · WISTAR INSTITUTE · PI Luis J Montaner, James L. Riley · 2021 to 2026
$34.7M
REACH: Research Enterprise to Advance a Cure for HIVUM1AI164565 · NIAID · WEILL MEDICAL COLL OF CORNELL UNIV · PI Marina Caskey, R. Brad Jones · 2021 to 2026
$32.9M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
Patient and Population Health Outcomes Research SWGP30AI124414 · NIAID · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI Kathryn M. Anastos · 2017 to 2026
$28.3M
Northwestern University Clinical Trial UnitUM1AI069471 · NIAID · NORTHWESTERN UNIVERSITY AT CHICAGO · PI Chad J Achenbach · 2012 to 2026
$24.6M
Complementing broadly neutralizing antibodies and autologous responses to restrict virus escape and durably suppress HIV-1U01AI169767 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI Katharine June Bar, Rebecca Marie Lynch · 2022 to 2026
$8.4M
Defining the mechanisms of HIV resistance to bNAbs in humansU01AI169385 · NIAID · ROCKEFELLER UNIVERSITY · PI Marina Caskey · 2022 to 2026
$7.8M
BEAT-HIV Delaney UM1AI164570Lundbeck Foundation R313-2019-790National Institute of Allergy and Infectious DiseasesNIAID NIH HHS P01 AI131338NIAID NIH HHS P30 AI045008NIAID NIH HHS P30 AI124414NIAID NIH HHS R01 AI162646NIAID NIH HHS U01 AI169385NIAID NIH HHS U01 AI169767NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069419NIAID NIH HHS UM1 AI069471NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI106701NIAID NIH HHS UM1 AI164565NIAID NIH HHS UM1 AI164570NIH HHS UM1 AI068634Penn CFAR P30AI045008Statistical and Data Management Center
6 · The paper itself

Abstract

backgroundDevelopment of a screening assay for the clinical use of broadly neutralizing antibodies (bnAbs) is a priority for HIV therapy and cure initiatives.

methodsWe assessed the PhenoSense Monoclonal Antibody Assay (Labcorp-Monogram Biosciences), which is Clinical Laboratory Improvement Amendments (CLIA) validated and has been used prospectively and retrospectively in multiple recent bnAb clinical trials.

resultsWhen performed on plasma and longitudinal peripheral blood mononuclear cell samples (before and during antiretroviral therapy, respectively), as sourced from a recent clinical trial, the PhenoSense assay produced robust reproducibility, concordance across sample types, and expected ranges in the susceptibility measures of bnAbs in clinical development. When applied retrospectively to baseline samples from 3 recent studies, the PhenoSense assay correlated with published laboratory-based study evaluations, but baseline bnAb susceptibility was not consistently predictive of durable virus suppression. Assessment of assay feasibility in 4 recent clinical studies provides estimates of assay success rate and processing time.

conclusionsThe PhenoSense Monoclonal Antibody Assay provides reproducible bnAb susceptibility measurements across relevant sample types yet is not consistently predictive of virus suppression. Logistical and operational assay requirements can affect timely clinical trial conduct. These results inform bnAb studies in development.

Indexed as

Antibodies, NeutralizingHIV-1HIV AntibodiesHIV InfectionsNeutralization TestsAntibodies, MonoclonalHumansLeukocytes, MononuclearReproducibility of ResultsRetrospective StudiesAntibodies, MonoclonalAntibodies, NeutralizingHIV Antibodiesbroadly neutralizing antibodiesclinical trialsHIVscreening assays

Identifiers

PMID39441137
PMCPMC11841631

What OpenQuestion holds

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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.