Evidence map›Paper›PMID 25820067›Full record

ArticleVaccine2015

Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials.

Xia Jin, Cecilia Morgan, Xuesong Yu, Stephen DeRosa, Georgia D Tomaras, David C Montefiori, James Kublin, Larry Corey, Michael C Keefer, NIAID HIV Vaccine Trials Network

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Vaccine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 13% 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

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

  1. Pooled it
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  7. Review
  8. Article
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  11. Article
  12. Article
  13. Article
  14. Causal Isotonic Regression.Journal of the Royal Statistical Society. Series B, Statistical methodology · 2020
    Article
  15. Innovations in HIV-1 Vaccine Design.Clinical therapeutics · 2020
    Review
  16. Article
  17. Article
  18. Review
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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

10 authors at 4 institutions in 1 country.

Xia JinInfectious Diseases Division, University of Rochester School of Medicine and Dentistry, 601 Elmwood Avenue, Box 689, Rochester, NY 14642-0002, United States. Electronic address: xjin@ips.ac.cn.
Cecilia MorganVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, PO Box 19204, Seattle, WA 98109-1024, United States. Electronic address: cmorgan@fredhutch.org.
Xuesong YuVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, PO Box 19204, Seattle, WA 98109-1024, United States. Electronic address: xyu@scharp.org.
Stephen DeRosaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, PO Box 19204, Seattle, WA 98109-1024, United States. Electronic address: sderosa@fredhutch.org.
Georgia D TomarasDuke University Medical Center, 106 Research Drive, Durham, NC 27710, United States. Electronic address: georgia.tomaras@duke.edu.
David C MontefioriDuke University Medical Center, 106 Research Drive, Durham, NC 27710, United States. Electronic address: david.montefiori@duke.edu.
James KublinVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, PO Box 19204, Seattle, WA 98109-1024, United States. Electronic address: jkublin@fredhutch.org.
Larry CoreyVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, PO Box 19204, Seattle, WA 98109-1024, United States. Electronic address: lcorey@fredhutch.org.
Michael C KeeferInfectious Diseases Division, University of Rochester School of Medicine and Dentistry, 601 Elmwood Avenue, Box 689, Rochester, NY 14642-0002, United States. Electronic address: michael_keefer@urmc.rochester.edu.
NIAID HIV Vaccine Trials Network
Fred Hutch Cancer Center · USDuke University · USUniversity of Rochester · USUniversity of Rochester Medical Center · 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 Rochester HIV/AIDS Clinical Trials Unit Administrative SupplementUM1AI069511 · NIAID · UNIVERSITY OF ROCHESTER · PI Paul R Bohjanen, MICHAEL C KEEFER · 2012 to 2026
$25.7M
NIAID NIH HHS 2 UM1 AI068614-08NIAID NIH HHS 2 UM1 AI068618-08NIAID NIH HHS 2 UM1AI068635-08NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1-AI-068618NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI069511NIAID NIH HHS UM1-AI-069511
6 · The paper itself

Abstract

Plasmid DNA vaccines have been licensed for use in domesticated animals because of their excellent immunogenicity, but none have yet been licensed for use in humans. Here we report a retrospective analysis of 1218 healthy human volunteers enrolled in 10 phase I clinical trials in which DNA plasmids encoding HIV antigens were administered. Elicited T-cell immune responses were quantified by validated intracellular cytokine staining (ICS) stimulated with HIV peptide pools. HIV-specific binding and neutralizing antibody activities were also analyzed using validated assays. Results showed that, in the absence of adjuvants and boosting with alternative vaccines, DNA vaccines elicited CD8+ and CD4+ T-cell responses in an average of 13.3% (95% CI: 9.8-17.8%) and 37.7% (95% CI: 31.9-43.8%) of vaccine recipients, respectively. Three vaccinations (vs. 2) improved the proportion of subjects with antigen-specific CD8+ responses (p=0.02), as did increased DNA dosage (p=0.007). Furthermore, female gender and participants having a lower body mass index were independently associated with higher CD4+ T-cell response rate (p=0.001 and p=0.008, respectively). These vaccines elicited minimal neutralizing and binding antibody responses. These findings of the immunogenicity of HIV DNA vaccines in humans can provide guidance for future clinical trials.

Indexed as

Adjuvants, ImmunologicAdolescentAdultAIDS VaccinesBody Mass IndexCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesEnzyme-Linked Immunospot AssayFemaleHealthy VolunteersHIV-1HIV AntibodiesHIV AntigensHumansInjections, IntramuscularInterferon-gammaAdjuvants, ImmunologicAIDS VaccinesHIV AntibodiesHIV AntigensInterferon-gammaVaccines, DNAClinical trialDNA vaccineHIVImmune response

Identifiers

PMID25820067
PMCPMC4433533
OpenAlexW1978550048

What OpenQuestion holds

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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.