Evidence map›Paper›PMID 17109336›Full record

Trial reportThe Journal of infectious diseases2006

Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine.

Barney S Graham, Richard A Koup, Mario Roederer, Robert T Bailer, Mary E Enama, Zoe Moodie, Julie E Martin, Margaret M McCluskey, Bimal K Chakrabarti, Laurie Lamoreaux and 5 more

Open access · hybridAbstract readClinical TrialClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 116 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
116citing papers in PubMed, 1 pooled it
9.3field-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

116 citing papers in PubMed, 1 synthesis or guideline pooled it, 217 citations in OpenAlex.

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  14. Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine.The New England journal of medicine · 2013
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56 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 3 institutions in 1 country.

Barney S GrahamVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892-3017, USA. bgraham@mail.nih.gov
Richard A Koup
Mario Roederer
Robert T Bailer
Mary E Enama
Zoe Moodie
Julie E Martin
Margaret M McCluskey
Bimal K Chakrabarti
Laurie Lamoreaux
Charla A Andrews
Phillip L Gomez
John R Mascola
Gary J Nabel
Vaccine Research Center 004 Study Team
National Institutes of Health · USNational Institute of Allergy and Infectious Diseases · USFred Hutch Cancer Center · US

Funding

Development/Production of Multiclade HIV-1 DNA Plasmid VZ01AI005040 · NIAID · NIAID EXTRAMURAL ACTIVITIES · PI WALLACE, KIMBERLY · 2002 to 2008
$11.8M
Screening Subjects For Preventive HIV Vaccine StudiesZ01AI005035 · NIAID · NIAID EXTRAMURAL ACTIVITIES · PI GRAHAM, BARNEY SCOTT · 2002 to 2008
$3.8M
HIV/AIDS Vaccine DevelopmentZ01AI005002 · NIAID · NIAID EXTRAMURAL ACTIVITIES · PI NABEL, GARY J · 2002 to 2008
$3.5M
Testing of Blood Samples for Immune Response /VaccineZ01AI005073 · NIAID · NIAID EXTRAMURAL ACTIVITIES · PI KOUP, RICHARD A · 2004 to 2008
$2.6M
Intramural NIH HHS Z99 AI999999
6 · The paper itself

Abstract

backgroundGene-based vaccine delivery is an important strategy in the development of a preventive vaccine for acquired immunodeficiency syndrome (AIDS). Vaccine Research Center (VRC) 004 is the first phase 1 dose-escalation study of a multiclade HIV-1 DNA vaccine.

methodsVRC-HIVDNA009-00-VP is a 4-plasmid mixture encoding subtype B Gag-Pol-Nef fusion protein and modified envelope (Env) constructs from subtypes A, B, and C. Fifty healthy, uninfected adults were randomized to receive either placebo (n=10) or study vaccine at 2 mg (n=5), 4 mg (n=20), or 8 mg (n=15) by needle-free intramuscular injection. Humoral responses (measured by enzyme-linked immunosorbant assay, Western blotting, and neutralization assay) and T cell responses (measured by enzyme-linked immunospot assay and intracellular cytokine staining after stimulation with antigen-specific peptide pools) were measured.

resultsThe vaccine was well tolerated and induced cellular and humoral responses. The maximal CD4(+) and CD8(+) T cell responses occurred after 3 injections and were in response to Env peptide pools. The pattern of cytokine expression by vaccine-induced HIV-specific T cells evolved over time, with a diminished frequency of interferon- gamma -producing T cells and an increased frequency of interleukin-2-producing T cells at 1 year.

conclusionsDNA vaccination induced antibody to and T cell responses against 3 major HIV-1 subtypes and will be further evaluated as a potential component of a preventive AIDS vaccine regimen.

Indexed as

Genetic VectorsImmunization ScheduleNeutralization TestsPlasmidsVaccinationAdolescentAdultAIDS VaccinesAntibodies, ViralAntibody SpecificityBlotting, WesternCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesCytokinesDouble-Blind MethodEnzyme-Linked Immunosorbent AssayAIDS VaccinesAntibodies, ViralCytokinesFusion Proteins, gag-polGene Products, nefnef Gene Products, Human Immunodeficiency VirusVaccines, DNAViral Envelope Proteins

Identifiers

PMID17109336
PMCPMC2428069
OpenAlexW2160663355

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.