Evidence map›Paper›PMID 21282192›Full record

Trial reportThe Journal of infectious diseases2011

Phase 1 safety and immunogenicity testing of DNA and recombinant modified vaccinia Ankara vaccines expressing HIV-1 virus-like particles.

Paul A Goepfert, Marnie L Elizaga, Alicia Sato, Li Qin, Massimo Cardinali, Christine M Hay, John Hural, Stephen C DeRosa, Olivier D DeFawe, Georgia D Tomaras and 11 more

4 registry-linked trialsAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 111 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
111citing papers in PubMed, 1 pooled it
–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.

NCT00301184 phase1completednot on this map

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of pGA2/JS7 DNA Vaccine and Recombinant Modified Vaccinia Ankara/HIV62 Vaccine in Healthy, HIV-1-Uninfected Adult Participants

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2006 to 2008Enrolled120ConditionsHIV InfectionsArmspGA2/JS7 DNA, Modified vaccinia Ankara/HIV62
NCT01571960 phase1completednot on this mapstarted 2012, after this paper: background citation

A Phase 1 Placebo Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of a Prime-Boost Vaccine Regimen of GEO-D03 DNA and MVA/HIV62B Vaccines in Healthy, HIV-1-Uninfected Vaccinia Naive Adult Participants

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2012 to 2016Enrolled48ConditionsHIV InfectionsArmsGEO-D03 DNA vaccine, MVA/HIV62B (MVA62B) vaccine, Placebo for GEO-D03 DNA, Placebo for MVA62B:
NCT01909414 phase1withdrawnnot on this map

A Phase 1 Study of the Safety and Immunogenicity of DNA/MVA Immunizations With Co-Expressed GM-CSF in HIV-1 Infected Young Adults With Suppressed Viremia on HAART

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrolled0ConditionsHIV InfectionsArmsGEO-D03 DNA Vaccine, MVA/HIV62B Vaccine, Placebo for DNA GEO-D03, Placebo for MVA/HIV62B Vaccine
NCT02485912 phase1completednot on this mapstarted 2015, after this paper: background citation

A Phase Ib Safety and Immunogenicity Clinical Trial of Heterologous Prime-boost Immunisation With ChAd3-EBO Z and MVA-EBO Z in Healthy Senegalese Adult Volunteers Aged 18-50 Years.

TypeinterventionalSponsorUniversity of OxfordRan2015 to 2016Enrolled40ConditionsEbola Virus DiseaseArmsChAd3-EBO Z, MVA-EBO Z
3 · Its place in the literature

Who cites it

111 citing papers in PubMed, 1 synthesis or guideline pooled it.

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51 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

21 authors.

Paul A GoepfertDepartment of Medicine, University of Alabama at Birmingham, AL 35294, USA. paulg@uab.edu
Marnie L Elizaga
Alicia Sato
Li Qin
Massimo Cardinali
Christine M Hay
John Hural
Stephen C DeRosa
Olivier D DeFawe
Georgia D Tomaras
David C Montefiori
Yongxian Xu
Lilin Lai
Spyros A Kalams
Lindsey R Baden
Sharon E Frey
William A Blattner
Linda S Wyatt
Bernard Moss
Harriet L Robinson
National Institute of Allergy and Infectious Diseases HIV Vaccine Trials Network

Funding

A-Z Clinical Trials UnitUM1AI069452 · NIAID · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Paul A. Goepfert · 2012 to 2026
$28.8M
University of Rochester HIV/AIDS Clinical Trials Unit Administrative SupplementUM1AI069511 · NIAID · UNIVERSITY OF ROCHESTER · PI Paul R Bohjanen, MICHAEL C KEEFER · 2012 to 2026
$25.7M
Recombinant Virus VaccinesZIAAI000416 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI MOSS, BERNARD · 2009 to 2025
$17.3M
Alabama-Clinical Trials UnitU01AI069452 · NIAID · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI SAAG, MICHAEL S. · 2007 to 2011
$16.6M
Units for HIV/AIDS Clinical Trials NetworksU01AI069511 · NIAID · UNIVERSITY OF ROCHESTER · PI KEEFER, MICHAEL C · 2007 to 2011
$12.0M
HIV VACCINE CLINICAL TRIAL UNIT AT SAINT LOUIS UNIVERU01AI048021 · NIAID · SAINT LOUIS UNIVERSITY · PI FREY, SHARON E. · 2000 to 2008
$11.9M
Vanderbilt HIV Clinical Trials UnitU01AI069439 · NIAID · VANDERBILT UNIVERSITY · PI D'AQUILA, RICHARD · 2007 to 2011
$8.8M
Harvard Medical School Vaccine Clinical Trials UnitU01AI069412 · NIAID · HARVARD MEDICAL SCHOOL · PI DOLIN, RAPHAEL · 2007 to 2011
$5.4M
Institute of Human Virology Clinical Trials UnitU01AI069447 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI DAVIS, CHARLES EDWARD · 2007 to 2011
$4.9M
NIAID NIH HHS U01 AI048021NIAID NIH HHS U01 AI069412NIAID NIH HHS U01 AI069439NIAID NIH HHS U01 AI069447NIAID NIH HHS U01 AI069452NIAID NIH HHS U01 AI069511NIAID NIH HHS UM1 AI069452NIAID NIH HHS UM1 AI069511
6 · The paper itself

Abstract

backgroundRecombinant DNA and modified vaccinia virus Ankara (rMVA) vaccines represent a promising approach to an HIV/AIDS vaccine. This Phase 1 clinical trial compared the safety and immunogenicity of a rMVA vaccine administered with and without DNA vaccine priming

methodsGeoVax pGA2/JS7 DNA (D) and MVA/HIV62 (M) vaccines encode noninfectious virus-like particles. Intramuscular needle injections were used to deliver placebo, 2 doses of DNA followed by 2 doses of rMVA (DDMM), one dose of DNA followed by 2 doses of rMVA (DMM), or 3 doses of rMVA (MMM) to HIV-seronegative participants.

resultsLocal and systemic symptoms were mild or moderate. Immune response rates for CD4 + and CD8 + T cells were highest in the DDMM group and lowest in the MMM group (77% vs 43% CD4 + and 42% vs 17% CD8 +). In contrast, response rates for Env binding and neutralizing Ab were highest in the MMM group. The DMM group had intermediate response rates. A 1/10th-dose DDMM regimen induced similar T cell but reduced Ab response rates compared with the full-dose DDMM.

conclusionsMVA62 was well tolerated and elicited different patterns of T cell and Ab responses when administered alone or in combination with the JS7 DNA vaccine.

Indexed as

AdolescentAdultAIDS VaccinesCD4 Lymphocyte CountCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesDouble-Blind MethodDrug Administration ScheduleEnzyme-Linked Immunosorbent AssayFemaleGenetic VectorsHIV-1HIV AntibodiesHIV InfectionsHumansMaleAIDS VaccinesHIV AntibodiesPlacebosVaccines, DNA

Identifiers

PMID21282192
PMCPMC3072720

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.