Evidence map›Paper›PMID 16988008›Full record

Trial reportClinical and vaccine immunology : CVI2006

A DNA vaccine for Ebola virus is safe and immunogenic in a phase I clinical trial.

Julie E Martin, Nancy J Sullivan, Mary E Enama, Ingelise J Gordon, Mario Roederer, Richard A Koup, Robert T Bailer, Bimal K Chakrabarti, Michael A Bailey, Phillip L Gomez and 6 more

3 registry-linked trialsOpen access · diamondAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical and vaccine immunology : CVI, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 115 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
115citing papers in PubMed, 1 pooled it
6.0field-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.

NCT02231866 phase1completednot on this mapstarted 2014, after this paper: background citation

VRC 207: A Phase I/1b, Open-Label, Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Ebola Chimpanzee Adenovirus Vector Vaccines, VRC-EBOADC069-00-VP (cAd3-EBO) and VRC-EBOADC076-00-VP (cAd3-EBOZ), in Healthy Adults

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2014 to 2017Enrolled143ConditionsHealthy Adult Immune Responses to VaccineArmsVRC-EBOADC069-00-VP, VRC-EBOADC076-00-VP
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
NCT05102643 phase1unknown statusnot on this mapstarted 2021, after this paper: background citation

A Phase 1, Randomized, Double-blinded, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 DNA Vaccine Delivered Intramuscularly Followed by Electroporation for COVID-19 in Healthy Adults

TypeinterventionalSponsorThe University of Hong KongRan2021 to 2022Enrolled30ConditionsCovid19ArmsSARS-CoV-2 DNA Vaccine, Matching placebo
3 · Its place in the literature

Who cites it

115 citing papers in PubMed, 1 synthesis or guideline pooled it, 235 citations in OpenAlex.

  1. Pooled it
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  18. Self-amplifying RNA vaccine protects mice against lethal Ebola virus infection.Molecular therapy : the journal of the American Society of Gene Therapy · 2023
    Article
  19. Review
  20. Review

55 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

16 authors at 3 institutions in 1 country.

Julie E MartinVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes, Bethesda, MD 20892-3017, USA.
Nancy J Sullivan
Mary E Enama
Ingelise J Gordon
Mario Roederer
Richard A Koup
Robert T Bailer
Bimal K Chakrabarti
Michael A Bailey
Phillip L Gomez
Charla A Andrews
Zoe Moodie
Lin Gu
Judith A Stein
Gary J Nabel
Barney S Graham
National Institutes of Health · USFred Hutch Cancer Center · USNational Institute of Allergy and Infectious Diseases · US

Funding

Influenza and Emerging and Re-emerging Infectious Diseases Vaccine StudiesZIAAI005047 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI DROPULIC, LESIA K · 2009 to 2025
$58.4M
Testing of Blood Samples for Immune Response and Vaccine ResearchZIAAI005073 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI KOUP, RICHARD A · 2009 to 2025
$23.4M
Ebola Vaccine DevelopmentZIAAI005079 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI SULLIVAN, NANCY J · 2009 to 2023
$22.7M
Ebola Vaccine Immune Correlates and Mechanism of ProtectionZIAAI005082 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI SULLIVAN, NANCY J · 2009 to 2023
$13.6M
Ebola VirologyZIAAI005081 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI MISASI, JOHN · 2009 to 2023
$12.1M
Marburg Vaccine DevelopmentZIAAI005080 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI SULLIVAN, NANCY J · 2009 to 2023
$8.6M
Testing of Blood Samples for Immune Response /VaccineZ01AI005073 · NIAID · NIAID EXTRAMURAL ACTIVITIES · PI KOUP, RICHARD A · 2004 to 2008
$2.6M
Screening Subjects for Vaccine Research StudiesZ01AI005047 · NIAID · NIAID EXTRAMURAL ACTIVITIES · PI GRAHAM, BARNEY SCOTT · 2003 to 2008
$2.5M
Ebola Vaccine DevelopmentZ01AI005079 · NIAID · NIAID EXTRAMURAL ACTIVITIES · PI SULLIVAN, NANCY J · 2005 to 2008
$1.1M
Marburg Vaccine DevelopmentZ01AI005080 · NIAID · NIAID EXTRAMURAL ACTIVITIES · PI SULLIVAN, NANCY J · 2005 to 2008
$1.1M
Ebola Vaccine Immune Correlates and Mechanism of ProtectionZ01AI005082 · NIAID · NIAID EXTRAMURAL ACTIVITIES · PI SULLIVAN, NANCY J · 2005 to 2008
$1.1M
Ebola VirologyZ01AI005081 · NIAID · NIAID EXTRAMURAL ACTIVITIES · PI SULLIVAN, NANCY J · 2005 to 2008
$1.1M
6 · The paper itself

Abstract

Ebola viruses represent a class of filoviruses that causes severe hemorrhagic fever with high mortality. Recognized first in 1976 in the Democratic Republic of Congo, outbreaks continue to occur in equatorial Africa. A safe and effective Ebola virus vaccine is needed because of its continued emergence and its potential for use for biodefense. We report the safety and immunogenicity of an Ebola virus vaccine in its first phase I human study. A three-plasmid DNA vaccine encoding the envelope glycoproteins (GP) from the Zaire and Sudan/Gulu species as well as the nucleoprotein was evaluated in a randomized, placebo-controlled, double-blinded, dose escalation study. Healthy adults, ages 18 to 44 years, were randomized to receive three injections of vaccine at 2 mg (n = 5), 4 mg (n = 8), or 8 mg (n = 8) or placebo (n = 6). Immunogenicity was assessed by enzyme-linked immunosorbent assay (ELISA), immunoprecipitation-Western blotting, intracellular cytokine staining (ICS), and enzyme-linked immunospot assay. The vaccine was well-tolerated, with no significant adverse events or coagulation abnormalities. Specific antibody responses to at least one of the three antigens encoded by the vaccine as assessed by ELISA and CD4(+) T-cell GP-specific responses as assessed by ICS were detected in 20/20 vaccinees. CD8(+) T-cell GP-specific responses were detected by ICS assay in 6/20 vaccinees. This Ebola virus DNA vaccine was safe and immunogenic in humans. Further assessment of the DNA platform alone and in combination with replication-defective adenoviral vector vaccines, in concert with challenge and immune data from nonhuman primates, will facilitate evaluation and potential licensure of an Ebola virus vaccine under the Animal Rule.

Indexed as

AdolescentAdultAntibodies, ViralDose-Response Relationship, ImmunologicEbola VaccinesEbolavirusFemaleHemorrhagic Fever, EbolaHumansInjections, IntramuscularMaleVaccines, DNAAntibodies, ViralEbola VaccinesVaccines, DNA

Identifiers

PMID16988008
PMCPMC1656552
OpenAlexW2116128249

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.