Evidence map›Paper›PMID 25225676›Full record

ArticleThe Journal of infectious diseases2015

Safety and immunogenicity of DNA vaccines encoding Ebolavirus and Marburgvirus wild-type glycoproteins in a phase I clinical trial.

Uzma N Sarwar, Pamela Costner, Mary E Enama, Nina Berkowitz, Zonghui Hu, Cynthia S Hendel, Sandra Sitar, Sarah Plummer, Sabue Mulangu, Robert T Bailer and 7 more

4 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in The Journal of infectious diseases, 2015. 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 73 papers.

0numbers the graph read from it
0cells of the map it votes in
73citing papers in PubMed
8.8field-weighted citation impact, top 2% 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.

NCT00605514 phase1completednot on this map

VRC 206: A Phase I Study to Evaluate the Safety and Immunogenicity of an Ebola DNA Plasmid Vaccine, VRC-EBODNA023-00-VP, and a Marburg DNA Plasmid Vaccine, VRC-MARDNA025-00-VP, in Healthy Adults

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2008 to 2010Enrolled20ConditionsEbola Vaccines, Marburg Virus Disease, Ebola Virus Disease, MarburgvirusArmsVRC-EBODNA023-00-VP, VRC-MARDNA025-00-VP
NCT02354404 phase1completednot on this map

Phase 1B, Open-Label, Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of the Investigational Ebola Vaccines, VRC-EBOADC069-00-VP, VRC-EBOADC076-00-VP and VRC-EBOMVA079-00-VP in Healthy Adults in Kampala Uganda

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2015 to 2017Enrolled90ConditionsHemorrhagic Fever, EbolaArmscAd3-EBOZ, cAd3-EBO, MVA-EbolaZ
NCT03475056 phase1completednot on this mapstarted 2018, after this paper: background citation

RV 507: A Phase I Open-Label, Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Marburg Chimpanzee Adenovirus Vector Vaccine, VRC-MARADC087-00-VP (cAd3-Marburg), in Healthy Adults

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2018 to 2019Enrolled40ConditionsMarburg Virus DiseaseArmscAd3-Marburg vaccine
NCT04041570 phase1completednot on this mapstarted 2019, after this paper: background citation

A Phase I Open-Label, Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of an Ebola Sudan Chimpanzee Adenovirus Vector Vaccine, VRC-EBOADC086-00-VP (cAd3-EBO S), in Healthy Adults

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2019 to 2020Enrolled40ConditionsEbola VirusArmscAd3-EBO S vaccine
3 · Its place in the literature

Who cites it

73 citing papers in PubMed, 131 citations in OpenAlex.

  1. Trial
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  15. Marburg Virus Medical Countermeasures.Methods in molecular biology (Clifton, N.J.) · 2025
    Review
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  17. Article
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  20. Article

13 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 2 institutions in 2 countries.

Uzma N SarwarVaccine Research Center.
Pamela CostnerVaccine Research Center.
Mary E EnamaVaccine Research Center.
Nina BerkowitzVaccine Research Center.
Zonghui HuBiostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Cynthia S HendelVaccine Research Center.
Sandra SitarVaccine Research Center.
Sarah PlummerVaccine Research Center.
Sabue MulanguVaccine Research Center.
Robert T BailerVaccine Research Center.
Richard A KoupVaccine Research Center.
John R MascolaVaccine Research Center.
Gary J NabelVaccine Research Center.
Nancy J SullivanVaccine Research Center.
Barney S GrahamVaccine Research Center.
Julie E LedgerwoodVaccine Research Center.
VRC 206 Study Team
National Institutes of Health · USInstitut de Recherche Vaccinale · FR

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
NIAID Vaccine Immune T cell and Antibody Laboratory CoreZICAI005123 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI KOUP, RICHARD A · 2013 to 2016
$15.1M
Marburg Vaccine DevelopmentZIAAI005080 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI SULLIVAN, NANCY J · 2009 to 2023
$8.6M
Intramural NIH HHS
6 · The paper itself

Abstract

backgroundEbolavirus and Marburgvirus cause severe hemorrhagic fever with high mortality and are potential bioterrorism agents. There are no available vaccines or therapeutic agents. Previous clinical trials evaluated transmembrane-deleted and point-mutation Ebolavirus glycoproteins (GPs) in candidate vaccines. Constructs evaluated in this trial encode wild-type (WT) GP from Ebolavirus Zaire and Sudan species and the Marburgvirus Angola strain expressed in a DNA vaccine.

methodsThe VRC 206 study evaluated the safety and immunogenicity of these DNA vaccines (4 mg administered intramuscularly by Biojector) at weeks 0, 4, and 8, with a homologous boost at or after week 32. Safety evaluations included solicited reactogenicity and coagulation parameters. Primary immune assessment was done by means of GP-specific enzyme-linked immunosorbent assay.

resultsThe vaccines were well tolerated, with no serious adverse events; 80% of subjects had positive enzyme-linked immunosorbent assay results (≥30) at week 12. The fourth DNA vaccination boosted the immune responses.

conclusionsThe investigational Ebolavirus and Marburgvirus WT GP DNA vaccines were safe, well tolerated, and immunogenic in this phase I study. These results will further inform filovirus vaccine research toward a goal of inducing protective immunity by using WT GP antigens in candidate vaccine regimens. CLINICAL TRIALS REGISTRATION: NCT00605514.

Indexed as

AdultAntibodies, ViralCytokinesEbola VaccinesEbolavirusEnzyme-Linked Immunospot AssayFemaleHumansMaleMarburgvirusMiddle AgedT-LymphocytesVaccines, DNAViral VaccinesYoung AdultAntibodies, ViralCytokinesEbola VaccinesVaccines, DNAViral VaccinesDNAebolaebolavirusfilovirusmarburgmarburgvirusvaccine

Identifiers

PMID25225676
PMCPMC4318920
OpenAlexW2115596188

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.