Evidence map›Paper›PMID 20078213›Full record

Trial reportThe Journal of infectious diseases2010

A phase 1/2 study of a multiclade HIV-1 DNA plasmid prime and recombinant adenovirus serotype 5 boost vaccine in HIV-Uninfected East Africans (RV 172).

Hannah Kibuuka, Robert Kimutai, Leonard Maboko, Fred Sawe, Mirjam S Schunk, Arne Kroidl, Douglas Shaffer, Leigh Anne Eller, Rukia Kibaya, Michael A Eller and 14 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
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 NCT00123968 (A Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Boosted by a Multiclade HIV-1 Recombinant Adenovirus-5 Vector Vaccine, VRC-HIVADV014-00-VP, in HIV Uninfected Adult Volunteers in East Africa), which is not on this map. Cited by 65 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 2 pooled it
5.2field-weighted citation impact, top 3% 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.

NCT00123968 phase1 / phase2completednot on this map

A Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Boosted by a Multiclade HIV-1 Recombinant Adenovirus-5 Vector Vaccine, VRC-HIVADV014-00-VP, in HIV Uninfected Adult Volunteers in East Africa

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2006 to 2012Enrolled326ConditionsHIV InfectionsArmsVRC-HIVDNA016-00-VP, VRC-HIVADV014-00-VP, VRC-DILUENT013-DIL-VP, VRC-HIVADV014-00-VP placebo
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 2 syntheses or guidelines pooled it, 105 citations in OpenAlex.

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  16. Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine.The New England journal of medicine · 2013
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5 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

24 authors at 8 institutions in 5 countries.

Hannah KibuukaMakerere University Walter Reed Project, Kampala, Uganda.
Robert Kimutai
Leonard Maboko
Fred Sawe
Mirjam S Schunk
Arne Kroidl
Douglas Shaffer
Leigh Anne Eller
Rukia Kibaya
Michael A Eller
Karin B Schindler
Alexandra Schuetz
Monica Millard
Jason Kroll
Len Dally
Michael Hoelscher
Robert Bailer
Josephine H Cox
Mary Marovich
Deborah L Birx
Barney S Graham
Nelson L Michael
Mark S de Souza
Merlin L Robb
Ludwig-Maximilians-Universität München · DEMakerere University Walter Reed Project · UGUnited States Army Medical Research Directorate - Africa · KEEmmes (United States) · USNational Institute of Allergy and Infectious Diseases · USArmed Forces Research Institute of Medical Science · THCenters for Disease Control and Prevention · USInternational AIDS Vaccine Initiative · US

Funding

HIV Vaccine StudiesZIAAI005035 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI DROPULIC, LESIA K · 2009 to 2025
$89.4M
FILARIASIS REPOSITORY RESEARCH SERVICEN01AI002642 · NIAID · UNIVERSITY OF GEORGIA (UGA) · PI MC CALL, JOHN W · 1985 to 1987
–
NIAID NIH HHS Y01 AI002642
6 · The paper itself

Abstract

backgroundHuman immunodeficiency virus (HIV) vaccine development remains a global priority. We describe the safety and immunogenicity of a multiclade DNA vaccine prime with a replication-defective recombinant adenovirus serotype 5 (rAd5) boost.

methodsThe vaccine is a 6-plasmid mixture encoding HIV envelope (env) subtypes A, B, and C and subtype B gag, pol, and nef, and an rAd5 expressing identical genes, with the exception of nef. Three hundred and twenty-four participants were randomized to receive placebo (n=138), a single dose of rAd5 at 10(10) (n = 24) or 10(11) particle units (n = 24), or DNA at 0, 1, and 2 months, followed by rAd5 at either 10(10) (n= 114) or 10(11) particle units (n = 24) boosting at 6 months. Participants were followed up for 24 weeks after the final vaccination.

resultsThe vaccine was safe and well tolerated. HIV-specific T cell responses were detected in 63% of vaccinees. Titers of preexisting Ad5 neutralizing antibody did not affect the frequency and magnitude of T cell responses in prime-boost recipients but did affect the response rates in participants that received rAd5 alone (P = .037).

conclusionThe DNA/rAd5 vaccination regimen was safe and induced HIV type 1 multi-clade T cell responses, which were not significantly affected by titers of preexisting rAd5 neutralizing antibody. Trial Registration. ClinicalTrials.gov identifier: NCT00123968 .

Indexed as

AdenoviridaeAdolescentAdultAfrica, EasternAIDS VaccinesAntibodies, NeutralizingAntibodies, ViralAntigens, ViralCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesCells, CulturedDNA, ViralDouble-Blind MethodEnzyme-Linked Immunosorbent AssayFemaleHIV-1AIDS VaccinesAntibodies, NeutralizingAntibodies, ViralAntigens, ViralDNA, ViralHuman Immunodeficiency Virus ProteinsInterferon-gammaVaccines, DNA

Identifiers

PMID20078213
PMCPMC2811694
OpenAlexW2171139716

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.