Evidence map›Paper›PMID 35551291›Full record

Trial reportNature medicine2022

Safety and antiviral activity of triple combination broadly neutralizing monoclonal antibody therapy against HIV-1: a phase 1 clinical trial.

Boris Julg, Kathryn E Stephenson, Kshitij Wagh, Sabrina C Tan, Rebecca Zash, Stephen Walsh, Jessica Ansel, Diane Kanjilal, Joseph Nkolola, Victoria E K Walker-Sperling and 27 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Nature medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03205917 (A Phase 1 Randomized Placebo-controlled Clinical Trial of the Safety, Pharmacokinetics and Antiviral Activity of PGDM1400 and PGT121 and VRC07-523LS Monoclonal Antibodies in HIV-uninfected and HIV-infected Adults), which is not on this map. Cited by 98 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
98citing papers in PubMed, 2 pooled it
9.4field-weighted citation impact, top 1% 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.

NCT03205917 phase1completednot on this map

A Phase 1 Randomized Placebo-controlled Clinical Trial of the Safety, Pharmacokinetics and Antiviral Activity of PGDM1400 and PGT121 and VRC07-523LS Monoclonal Antibodies in HIV-uninfected and HIV-infected Adults

TypeinterventionalSponsorInternational AIDS Vaccine InitiativeRan2017 to 2020Enrolled29ConditionsHIV InfectionsArmsPGDM1400/Placebo (3mg/kg IV), PGDM1400/Placebo (10mg/kg IV), PGDM1400/Placebo (30mg/kg IV), PGDM1400 + PGT121/Placebo (3mg/kg + 3mg/kg IV), PGDM1400 + PGT121/Placebo (10mg/kg + 10mg/kg IV)
3 · Its place in the literature

Who cites it

98 citing papers in PubMed, 2 syntheses or guidelines pooled it, 132 citations in OpenAlex.

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38 more citing papers are in PubMed but not listed here.

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

37 authors at 7 institutions in 1 country.

Boris Julg *Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA.ORCID http://orcid.org/0000-0002-4687-9626
Kathryn E Stephenson *Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA.
Kshitij Wagh *Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.
Sabrina C TanCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Rebecca ZashCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Stephen WalshCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.ORCID http://orcid.org/0000-0002-0817-9370
Jessica AnselCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Diane KanjilalCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Joseph NkololaCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Victoria E K Walker-SperlingCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Jasper OphelCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.ORCID http://orcid.org/0000-0002-0040-1328
Katherine YanosickCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Erica N BorducchiCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Lori MaxfieldCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.ORCID http://orcid.org/0000-0002-7595-6205
Peter AbbinkCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.ORCID http://orcid.org/0000-0003-1978-088X
Lauren PeterCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.ORCID http://orcid.org/0000-0002-2105-7503
Nicole L YatesDuke Human Vaccine Institute, Duke University, Durham, NC, USA.
Martina S WesleyDuke Human Vaccine Institute, Duke University, Durham, NC, USA.ORCID http://orcid.org/0000-0002-8664-9307
Tom HassellInternational AIDS Vaccine Initiative, New York, NY, USA.
Huub C GelderblomInternational AIDS Vaccine Initiative, New York, NY, USA.ORCID http://orcid.org/0000-0003-4786-1003
Allen deCampStatistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Bryan T MayerStatistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.ORCID http://orcid.org/0000-0003-2258-5276
Alicia SatoStatistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Monica W GerberStatistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Elena E GiorgiTheoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.
Lucio GamaVaccine Research Center, National Institute of Health, Bethesda, MD, USA.
Richard A KoupVaccine Research Center, National Institute of Health, Bethesda, MD, USA.
John R MascolaVaccine Research Center, National Institute of Health, Bethesda, MD, USA.
Ana MonczorHouston AIDS Research Team, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, USA.
Sofia LupoHouston AIDS Research Team, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, USA.
Charlotte-Paige RolleOrlando Immunology Center, Orlando, FL, USA.
Roberto ArduinoHouston AIDS Research Team, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, USA.
Edwin DeJesusOrlando Immunology Center, Orlando, FL, USA.
Georgia D TomarasDuke Human Vaccine Institute, Duke University, Durham, NC, USA.
Michael S SeamanCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Bette KorberTheoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.ORCID http://orcid.org/0000-0002-2026-5757
Dan H BarouchRagon Institute of MGH, MIT and Harvard, Cambridge, MA, USA. dbarouch@bidmc.harvard.edu.ORCID http://orcid.org/0000-0001-5127-4659
Beth Israel Deaconess Medical Center · USFred Hutch Cancer Center · USDuke University · USLos Alamos National Laboratory · USThe University of Texas Health Science Center at Houston · USInternational AIDS Vaccine Initiative · USOrlando Immunology Center · US

Funding

Harvard Clinical and Translational Science CenterUL1TR001102 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2013 to 2017
$106.2M
The impact of HIV viral diversity and cellular immunity on HIV pathogenesisP30AI060354 · NIAID · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI RAJESH T GANDHI · 2004 to 2026
$94.4M
Consortia for Innovative AIDS Research in Nonhuman PrimatesUM1AI124377 · NIAID · BETH ISRAEL DEACONESS MEDICAL CENTER · PI BAROUCH, DAN H., PICKER, LOUIS J. · 2016 to 2021
$53.0M
Virus and Antibody Gene Sequencing CoreP01AI131251 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI GEORGE M SHAW · 2017 to 2026
$40.7M
I4C 2.0: Immunotherapy for CureUM1AI164556 · NIAID · BETH ISRAEL DEACONESS MEDICAL CENTER · PI Dan H. Barouch, John W Mellors · 2021 to 2026
$28.0M
Combined Immunologic Approaches to Cure HIV-1UM1AI126603 · NIAID · BETH ISRAEL DEACONESS MEDICAL CENTER · PI BAROUCH, DAN H., MELLORS, JOHN W · 2016 to 2020
$23.6M
HIV/SIV Replication In VivoZIAAI005014 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI KOUP, RICHARD A · 2009 to 2025
$22.7M
Project 2U19AI128751 · NIAID · BETH ISRAEL DEACONESS MEDICAL CENTER · PI BAROUCH, DAN H. · 2018 to 2022
$14.0M
Ad26 Based Therapeutic Vaccines for HIVU01AI145801 · NIAID · BETH ISRAEL DEACONESS MEDICAL CENTER · PI BAROUCH, DAN H., JUELG, BORIS DOMINIK · 2020 to 2025
$9.0M
Multidisciplinary HIV Training ProgramT32AI007387 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI Daniel R. Kuritzkes · 1990 to 2026
$8.8M
Single-Cell Analysis of the HIV/SIV ReservoirR01AI149670 · NIAID · BETH ISRAEL DEACONESS MEDICAL CENTER · PI BAROUCH, DAN H., SHALEK, ALEX K · 2020 to 2024
$4.6M
Impact of the Intestinal Microbiome on HIV/SIV VaccinesR01OD024917 · OD · WASHINGTON UNIVERSITY · PI BALDRIDGE, MEGAN T, BAROUCH, DAN H. · 2017 to 2021
$4.3M
NCATS NIH HHS UL1 TR001102NIAID NIH HHS K08 AI106408NIAID NIH HHS K23 AI114381NIAID NIH HHS P01 AI131251NIAID NIH HHS P30 AI060354NIAID NIH HHS R01 AI129797NIAID NIH HHS R01 AI149670NIAID NIH HHS T32 AI007387NIAID NIH HHS U01 AI145801NIAID NIH HHS U19 AI128751NIAID NIH HHS UM1 AI124377NIAID NIH HHS UM1 AI126603NIAID NIH HHS UM1 AI164556NIH HHS R01 OD024917
6 · The paper itself

Abstract

HIV-1 therapy with single or dual broadly neutralizing antibodies (bNAbs) has shown viral escape, indicating that at least a triple bNAb therapy may be needed for robust suppression of viremia. We performed a two-part study consisting of a single-center, randomized, double-blind, dose-escalation, placebo-controlled first-in-human trial of the HIV-1 V2-glycan-specific antibody PGDM1400 alone or in combination with the V3-glycan-specific antibody PGT121 in 24 adults without HIV in part 1, as well as a multi-center, open-label trial of the combination of PGDM1400, PGT121 and the CD4-binding-site antibody VRC07-523LS in five viremic adults living with HIV not on antiretroviral therapy (ART) in part 2 ( NCT03205917 ). The primary endpoints were safety, tolerability and pharmacokinetics for both parts and antiviral activity among viremic adults living with HIV and not on ART for part 2 of the study. The secondary endpoints were changes in CD4

Indexed as

HIV-1HIV InfectionsHIV SeropositivityAdultAntibodies, MonoclonalAntibodies, NeutralizingAntiviral AgentsBroadly Neutralizing AntibodiesHIV AntibodiesHumansViremiaAntibodies, MonoclonalAntibodies, NeutralizingAntiviral AgentsBroadly Neutralizing AntibodiesHIV Antibodies

Identifiers

PMID35551291
PMCPMC9205771
OpenAlexW4280561770

What OpenQuestion holds

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Registered trials

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.