Evidence map›Paper›PMID 26761518›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2016

The Safety and Immunogenicity of an Interleukin-12-Enhanced Multiantigen DNA Vaccine Delivered by Electroporation for the Treatment of HIV-1 Infection.

Jeffrey M Jacobson, Lu Zheng, Cara C Wilson, Pablo Tebas, Roy M Matining, Michael A Egan, John Eldridge, Alan L Landay, David B Clifford, Anne F Luetkemeyer and 8 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
3.9field-weighted citation impact, top 7% 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

13 citing papers in PubMed, 37 citations in OpenAlex.

  1. Immunotherapy Targeting HPV16/18 Generates Potent Immune Responses in HPV-Associated Head and Neck Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2019
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  12. The Safety and Immunogenicity of GTUFrontiers in immunology · 2019
    Article
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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

18 authors at 13 institutions in 1 country.

Jeffrey M Jacobson*Division of Infectious Diseased and HIV Medicine, Drexel University College of Medicine, Philadelphia, PA;†Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA;‡Division of Infectious Diseases, University of Colorado, Denver, CO;§Division of Infectious Diseases, University of Pennsylvania, Philadelphia, PA;‖Profectus BioSciences, Inc., Tarrytown, NY;¶Department of Immunology and Microbiology, Rush University School of Medicine, Chicago, IL;#Department of Neurology, Washington University School of Medicine, St. Louis, MO;**HIV/AIDS Division, University of California, San Francisco, CA;††Social and Scientific Systems, Inc., Silver Springs, MD;‡‡Division of AIDS, NIAID, Bethesda, MD;§§Frontier Science, Amherst, NY; and‖‖Fred Hutchinson Cancer Research Center and University of Washington, Seattle, WA.
Lu Zheng
Cara C Wilson
Pablo Tebas
Roy M Matining
Michael A Egan
John Eldridge
Alan L Landay
David B Clifford
Anne F Luetkemeyer
Jennifer Tiu
Ana L Martinez
Jennifer Janik
Teresa A Spitz
John Hural
Juliana McElrath
Nicole Frahm
ACTG A5281 Protocol Team
Harvard University · USProfectus Biosciences (United States) · USUniversity of Washington · USWashington University in St. Louis · USDrexel University · USFred Hutch Cancer Center · USFrontier Science & Technology Research Foundation · USOffice of AIDS Research · USRush University · USSocial and Scientific Systems (United States) · USUniversity of California, San Francisco · USUniversity of Colorado Denver · USUniversity of Pennsylvania · US

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 ROBERT GROSS · 1999 to 2026
$78.6M
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
UCLA Clinical and Translational Science InstituteUL1TR000124 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DUBINETT, STEVEN M. · 2012 to 2015
$57.0M
UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Judith S. Currier, RAPHAEL J LANDOVITZ · 2012 to 2026
$51.8M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
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
Terry Beirn CPCRA Clinical Trials UnitUM1AI069503 · NIAID · GEORGE WASHINGTON UNIVERSITY · PI KAN, VIRGINIA · 2012 to 2020
$38.5M
NCATS NIH HHS UL1 TR000124NCATS NIH HHS UL1 TR001082NCRR NIH HHS UL1 RR024160NIAID NIH HHS 2 UM1 AI068636-08NIAID NIH HHS 2UM1AI069412-08NIAID NIH HHS 2UM1AI069432NIAID NIH HHS 2UM1AI069501NIAID NIH HHS 2 UM1 AI069503-08NIAID NIH HHS 2UM1AI069511-08NIAID NIH HHS 5-P30-AI-045008-15NIAID NIH HHS AI069556NIAID NIH HHS F32 AI080062NIAID NIH HHS HHSN272200800062CNIAID NIH HHS P30 AI045008NIAID NIH HHS U01 AI069439NIAID NIH HHS U01 AI069556NIAID NIH HHS U01 AI69439NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1AI068636NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069439NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI069501NIAID NIH HHS UM1 AI069503NIAID NIH HHS UM1 AI069511NIAID NIH HHS UM1 AI069534NIAID NIH HHS UM1 AI069534-08NIAID NIH HHS UM1 AI069556NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

backgroundTherapeutic vaccination is being studied in eradication and "functional cure" strategies for HIV-1. The Profectus Biosciences multiantigen (MAG) HIV-1 DNA vaccine encodes HIV-1 Gag/Pol, Nef/Tat/Vif, and Envelope, and interleukin-12 (IL-12) and is delivered by electroporation combined with intramuscular injection (IM-EP).

methodsSixty-two HIV-1-infected patients on antiretroviral therapy (plasma HIV-1 RNA levels ≤ 200 copies/mL; CD4(+) T-cell counts ≥ 500 cells/mm(3)) were randomly allocated 5:1 to receive vaccine or placebo. At weeks 0, 4, and 12, 4 consecutive cohorts received 3000 μg HIV MAG pDNA with 0, 50, 250, or 1000 μg of IL-12 pDNA by IM-EP. A fifth cohort received HIV MAG pDNA and 1000 μg of IL-12 pDNA by standard IM injection.

resultsCD4(+) T cells expressing IL-2 in response to Gag and Pol and interferon-γ responses to Gag, Pol, and Env increased from baseline to week 14 in the low-dose (50-μg) IL-12 arm vs. placebo (P < 0.05; intracellular cytokine staining). The total increase in the IL-2-expressing CD4 T-cell responses to any antigen was also higher in the low-dose IL-12 arm vs. placebo (P = 0.04). Cytokine responses by CD8 T cells to HIV antigens were not increased in any vaccine arm relative to placebo.

conclusionsHIV-1 MAG/low-dose IL-12 DNA vaccine delivered by IM-EP augmented CD4(+) but not CD8(+) T-cell responses to multiple HIV-1 antigens.

Indexed as

AdolescentAdultAIDS VaccinesCD4-Positive T-LymphocytesCytokinesElectroporationFemaleHIV-1HIV AntigensHIV InfectionsHumansInterferon-gammaInterleukin-12Interleukin-2MaleMiddle AgedAIDS VaccinesCytokinesHIV AntigensInterferon-gammaInterleukin-12Interleukin-2Vaccines, DNA

Identifiers

PMID26761518
PMCPMC4712745
OpenAlexW2417153089

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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.