Evidence map›Paper›PMID 23840043›Full record

Trial reportThe Journal of infectious diseases2013

Safety and comparative immunogenicity of an HIV-1 DNA vaccine in combination with plasmid interleukin 12 and impact of intramuscular electroporation for delivery.

Spyros A Kalams, Scott D Parker, Marnie Elizaga, Barbara Metch, Srilatha Edupuganti, John Hural, Stephen De Rosa, Donald K Carter, Kyle Rybczyk, Ian Frank and 19 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 120 papers.

0numbers the graph read from it
0cells of the map it votes in
120citing papers in PubMed
27.7field-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.

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

120 citing papers in PubMed, 196 citations in OpenAlex.

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60 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

29 authors at 15 institutions in 2 countries.

Spyros A KalamsInfectious Diseases Division, Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee 37232, USA. s.kalams@vanderbilt.edu
Scott D Parker
Marnie Elizaga
Barbara Metch
Srilatha Edupuganti
John Hural
Stephen De Rosa
Donald K Carter
Kyle Rybczyk
Ian Frank
Jonathan Fuchs
Beryl Koblin
Denny H Kim
Patrice Joseph
Michael C Keefer
Lindsey R Baden
John Eldridge
Jean Boyer
Adam Sherwat
Massimo Cardinali
Mary Allen
Michael Pensiero
Chris Butler
Amir S Khan
Jian Yan
Niranjan Y Sardesai
James G Kublin
David B Weiner
NIAID HIV Vaccine Trials Network
Fred Hutch Cancer Center · USNational Institute of Allergy and Infectious Diseases · USInovio Pharmaceuticals (United States) · USUniversity of Pennsylvania · USAstellas Pharma (United States) · USBrigham and Women's Hospital · USEmory University · USGheskio Centers · HTNew York Blood Center · USOffice of Infectious Diseases · USProfectus Biosciences (United States) · USSan Francisco Department of Public Health · USUniversity of Alabama · USUniversity of Rochester · USVanderbilt University · 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
SDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9M
UNIVERSITY OF PENNSYLVANIA CAN CTR SUPPORT GRANTP30CA016520 · NCI · UNIVERSITY OF PENNSYLVANIA · PI SHELLEY L BERGER · 1985 to 2026
$222.3M
Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI STEVEN Grant DEEKS · 1988 to 2026
$93.6M
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
Emory HIV/AIDS Clinical Trials UnitUM1AI069418 · NIAID · EMORY UNIVERSITY · PI Colleen F Kelley · 2012 to 2026
$46.0M
Columbia Partnership for Prevention and Control of HIV/AIDS Clinical Trials UnitUM1AI069470 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI MAGDALENA ELZBIETA SOBIESZCZYK · 2012 to 2026
$44.8M
The Vanderbilt Institute for Clinical and Translational Research (VICTR)UL1TR000445 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BERNARD, GORDON RAPHAEL · 2012 to 2016
$41.4M
Vanderbilt HIV Clinical Trials Unit (CTU)UM1AI069439 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI David W Haas, Spyros A Kalams · 2012 to 2026
$33.1M
University of Pennsylvania HIV Clinical Trials UnitUM1AI069534 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI Ian Frank, PABLO TEBAS · 2012 to 2026
$33.0M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
NCATS NIH HHS UL1 TR000445NCATS NIH HHS UL1TR000445NCI NIH HHS P30 CA016520NIAID NIH HHS HHSN272200800063CNIAID NIH HHS P01 AI071739NIAID NIH HHS P01-AI071739NIAID NIH HHS P30 AI027763NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069418NIAID NIH HHS UM1 AI069421NIAID NIH HHS UM1AI069421NIAID NIH HHS UM1 AI069439NIAID NIH HHS UM1 AI069452NIAID NIH HHS UM1 AI069470NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI069511NIAID NIH HHS UM1 AI069534
6 · The paper itself

Abstract

backgroundDNA vaccines have been very poorly immunogenic in humans but have been an effective priming modality in prime-boost regimens. Methods to increase the immunogenicity of DNA vaccines are needed.

methodsHIV Vaccine Trials Network (HVTN) studies 070 and 080 were multicenter, randomized, clinical trials. The human immunodeficiency virus type 1 (HIV-1) PENNVAX®-B DNA vaccine (PV) is a mixture of 3 expression plasmids encoding HIV-1 Clade B Env, Gag, and Pol. The interleukin 12 (IL-12) DNA plasmid expresses human IL-12 proteins p35 and p40. Study subjects were healthy HIV-1-uninfected adults 18-50 years old. Four intramuscular vaccinations were given in HVTN 070, and 3 intramuscular vaccinations were followed by electroporation in HVTN 080. Cellular immune responses were measured by intracellular cytokine staining after stimulation with HIV-1 peptide pools.

resultsVaccination was safe and well tolerated. Administration of PV plus IL-12 with electroporation had a significant dose-sparing effect and provided immunogenicity superior to that observed in the trial without electroporation, despite fewer vaccinations. A total of 71.4% of individuals vaccinated with PV plus IL-12 plasmid with electroporation developed either a CD4(+) or CD8(+) T-cell response after the second vaccination, and 88.9% developed a CD4(+) or CD8(+) T-cell response after the third vaccination.

conclusionsUse of electroporation after PV administration provided superior immunogenicity than delivery without electroporation. This study illustrates the power of combined DNA approaches to generate impressive immune responses in humans.

Indexed as

Adjuvants, ImmunologicAdolescentAdultAIDS VaccinesCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesCytokinesDNADrug Administration RoutesElectroporationFemaleHIV-1HumansInterleukin-12MaleMiddle AgedAdjuvants, ImmunologicAIDS VaccinesCytokinesDNAInterleukin-12electroporationplasmid cytokine adjuvantvaccination

Identifiers

PMID23840043
PMCPMC3733506
OpenAlexW2170704251

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.