Evidence map›Paper›PMID 20662716›Full record

Trial reportThe Journal of infectious diseases2010

AIDS clinical trials group 5197: a placebo-controlled trial of immunization of HIV-1-infected persons with a replication-deficient adenovirus type 5 vaccine expressing the HIV-1 core protein.

Robert T Schooley, John Spritzler, Hongying Wang, Michael M Lederman, Diane Havlir, Daniel R Kuritzkes, Richard Pollard, Cathy Battaglia, Michael Robertson, Devan Mehrotra and 4 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00080106 (A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Antiretroviral Effect of Immunization With the MRK Ad5 HIV-1 Gag Vaccine in HIV-1 Infected Individuals Who Interrupt Antiretroviral Therapy), which is not on this map. Cited by 75 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 11% 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.

NCT00080106 phase2completednot on this map

A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Antiretroviral Effect of Immunization With the MRK Ad5 HIV-1 Gag Vaccine in HIV-1 Infected Individuals Who Interrupt Antiretroviral Therapy

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2004 to 2011Enrolled114ConditionsHIV InfectionsArmsMRK Ad5 HIV-1 gag vaccine, Vaccine placebo
3 · Its place in the literature

Who cites it

75 citing papers in PubMed, 1 synthesis or guideline pooled it, 120 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Time to Viral Rebound After Interruption of Modern Antiretroviral Therapies.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Trial
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  16. Article
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  18. Viral and immune predictors of HIV posttreatment control.Current opinion in HIV and AIDS · 2025
    Review
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  20. Article

15 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

14 authors at 10 institutions in 3 countries.

Robert T SchooleyDiv. of Infectious Diseases,University of California-San Diego, 9500 Gilman Drive, La Jolla, CA 92093, USA. arsexton@ucsd.edu
John Spritzler
Hongying Wang
Michael M Lederman
Diane Havlir
Daniel R Kuritzkes
Richard Pollard
Cathy Battaglia
Michael Robertson
Devan Mehrotra
Danilo Casimiro
Kara Cox
Barbara Schock
AIDS Clinical Trials Group 5197 Study Team
United States Military Academy · USHarvard University · USBrigham and Women's Hospital · USCase Western Reserve University · USMerck (Japan) · JPMinistry of Science, Research and Technology · IRSocial and Scientific Systems (United States) · USUniversity of California, Davis · USUniversity of California, San Diego · USUniversity of California, San Francisco · US

Funding

WOMEN'S HEALTH AGENDAU01AI038858 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI BENSON, CONSTANCE ANN · 1996 to 2008
$157.5M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024996 · NCRR · WEILL MEDICAL COLL OF CORNELL UNIV · PI IMPERATO-MCGINLEY, JULIANNE L · 2007 to 2011
$49.6M
Case Clinical Trials Unit: Administrative Supplement NOSI AI-20-031.UM1AI069501 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI George Yendewa · 2012 to 2026
$40.4M
UNIVERSITY OF ROCHESTER'S RESEARCH ASSOCIATE ORGANIZATIONUL1RR024160 · NCRR · UNIVERSITY OF ROCHESTER · PI PEARSON, THOMAS ARTHUR · 2006 to 2011
$38.7M
Zonisamide in Patients with Neuropathic Pain Associated with Diabetic NeuropathyM01RR000046 · NCRR · UNIV OF NORTH CAROLINA CHAPEL HILL · PI JOY, MELANIE S · 1985 to 2008
$38.5M
ZOPOLRESTAT IN SUBJECTS W/ PERIPHERAL SYMMETRICAL DIABETIC POLYNEUROPATHYM01RR000096 · NCRR · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI NOVIK, YELENA · 1985 to 2008
$34.8M
University of Miami Developmental Center for AIDS Research (D-CFAR)P30AI073961 · NIAID · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI ALLAN E RODRIGUEZ · 2007 to 2026
$33.8M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
University of North Carolina AIDS Clinical Trials Unit (UNC ACTU)U01AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ERON, JOSEPH J · 2007 to 2011
$21.8M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitU01AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BENSON, CONSTANCE ANN · 2007 to 2011
$19.3M
NCRR NIH HHS M01RR000046-48NCRR NIH HHS M01RR00096NCRR NIH HHS RR024996NCRR NIH HHS UL1 RR024160NCRR NIH HHS UL1RR024160NIAID NIH HHS 1 U01 AI 069494-01NIAID NIH HHS 5 U01 AI 069424-03NIAID NIH HHS 5U01 AI069471NIAID NIH HHS 5U01 AI069502-03NIAID NIH HHS 5U01AI46376-05NIAID NIH HHS 5U0I AI069415-03NIAID NIH HHS AI 05002NIAID NIH HHS AI069434NIAID NIH HHS AI069472NIAID NIH HHS AI069474NIAID NIH HHS AI069477NIAID NIH HHS AI069532NIAID NIH HHS AI073961NIAID NIH HHS AI25859NIAID NIH HHS AI27665NIAID NIH HHS AI27675NIAID NIH HHS AI46370NIAID NIH HHS AI69432NIAID NIH HHS AI69501NIAID NIH HHS AI69556NIAID NIH HHS K24 AI051982NIAID NIH HHS P30 AI050410NIAID NIH HHS P30AI050410-11NIAID NIH HHS U01 AI027670NIAID NIH HHS U01 AI038858NIAID NIH HHS U01 AI069423NIAID NIH HHS U01AI069423-02NIAID NIH HHS U01AI069472-03NIAID NIH HHS U01AI069495NIAID NIH HHS U01AI069511NIAID NIH HHS U01 AI069532NIAID NIH HHS U01AI38858NIAID NIH HHS U01AI-69419NIAID NIH HHS UM1 AI069496
6 · The paper itself

Abstract

backgroundHuman immunodeficiency virus type 1 (HIV-1)-specific cellular immunity contributes to the control of HIV-1 replication. HIV-1-infected volunteers who were receiving antiretroviral therapy were given a replication-defective adenovirus type 5 HIV-1 gag vaccine in a randomized, blinded therapeutic vaccination study.

methodsHIV-1-infected vaccine or placebo recipients underwent analytical treatment interruption (ATI) for 16 weeks. The log(10) HIV-1 RNA load at the ATI set point and the time-averaged area under the curve served as co-primary end points. Immune responses were measured by intracellular cytokine staining and carboxyfluorescein succinimidyl ester dye dilution.

resultsVaccine benefit trends were seen for both primary end points, but they did not reach a prespecified significance level of P < or = 25. The estimated shifts in the time-averaged area under the curve and the ATI set point were 0.24 (P=.04, unadjusted) and 0.26 (P=.07, unadjusted) log(10) copies lower, respectively, in the vaccine arm than in the placebo arm. HIV-1 gag-specific CD4(+) cells producing interferon-gamma were an immunologic correlate of viral control.

conclusionThe vaccine was generally safe and well tolerated. Despite a trend favoring viral suppression among vaccine recipients, differences in HIV-1 RNA levels did not meet the prespecified level of significance. Induction of HIV-1 gag-specific CD4 cells correlated with control of viral replication in vivo. Future immunogenicity studies should require a substantially higher immunogenicity threshold before an ATI is contemplated.

Indexed as

AIDS VaccinesVaccines, DNAAdenoviridaeAdultCD4-Positive T-LymphocytesDouble-Blind MethodFemaleGene Products, gagHIV-1HIV InfectionsHumansImmunizationInterferon-gammaMaleTreatment OutcomeVirus ReplicationAIDS VaccinesGene Products, gagInterferon-gammaVaccines, DNA

Identifiers

PMID20662716
PMCPMC2916952
OpenAlexW2125075911

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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.