NCT00997607

Brief Summary

This study will test two new vaccines, one for Ebola and one for Marburg virus, to see if they are safe, if they have side effects, and if they create an immune response in people who receive them.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

January 28, 2013

Status Verified

January 1, 2013

Enrollment Period

2.2 years

First QC Date

October 16, 2009

Last Update Submit

January 25, 2013

Conditions

Ebola Virus DiseaseMarburg Virus Disease

Keywords

Vaccine

Outcome Measures

Primary Outcomes (2)

  • Safety of Ebola vaccine, as seen in local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse experiences

    Measured at 11 or more visits over 2 years

  • Safety of Marburg vaccine, as seen in local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse experiences

    Measured at 11 or more visits over 2 years

Secondary Outcomes (2)

  • Immunogenicity of Ebola vaccine, as seen in ELISA antigen-specific assays for antibodies, intracellular cytokine staining (ICS) assay, and an ELISPOT antigen-specific assay for T cell responses

    Measured at baseline and Week 12

  • Immunogenicity of Marburg vaccine, as seen in ELISA antigen-specific assays for antibodies, intracellular cytokine staining (ICS) assay, and an ELISPOT antigen-specific assay for T cell responses

    Measured at baseline and Week 12

Study Arms (3)

Ebola vaccine only

EXPERIMENTAL

Participants will receive only the Ebola vaccine or a placebo injection.

Biological: Ebola vaccineOther: Placebo injection

Marburg vaccine only

EXPERIMENTAL

Participants will receive only the Marburg vaccine or a placebo injection.

Biological: Marburg vaccineOther: Placebo injection

Ebola and Marburg vaccine

EXPERIMENTAL

Participants will receive both the Ebola and Marburg vaccines, one in each arm or placebo injections.

Biological: Ebola vaccineBiological: Marburg vaccineOther: Placebo injection

Interventions

Ebola vaccineBIOLOGICAL

4 mg of Ebola DNA plasmid vaccine, VRC-EBODNA023-00-VP, delivered via intramuscular injection on Weeks 0, 4, and 8

Ebola and Marburg vaccineEbola vaccine only
Marburg vaccineBIOLOGICAL

4 mg of Marburg DNA plasmid vaccine, VRC-MARDNA025-00-VP, delivered via intramuscular injection on Weeks 0, 4, and 8

Ebola and Marburg vaccineMarburg vaccine only
Placebo injectionOTHER

4 mg of saline injection delivered at Weeks 0, 4, and 8

Ebola and Marburg vaccineEbola vaccine onlyMarburg vaccine only

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Available for clinical follow-up through Week 104
  • Willing to have photo taken for identification purposes
  • Willing to be taken home at enrollment visit and allow home visits if appointments are not kept
  • Completes an Assessment of Understanding (AoU) prior to enrollment by answering 9 out of 10 questions at least once in 3 attempts
  • In good general health without clinically significant medical history
  • Has a physical examination and laboratory results without clinically significant findings within the 28 days prior to enrollment
  • Female participants of reproductive potential must have a negative result on a human choriogonadotropin (β-HCG) pregnancy test
  • Female participants must either be incapable of becoming pregnant or agree to take appropriate precautions that pregnancy will not occur during the first 24 weeks of the study

You may not qualify if:

  • Pregnant, breast-feeding, or planning to become pregnant during the first 24 weeks after enrollment
  • History of Ebola or Marburg virus exposure
  • Occupational health risk of exposure to the Ebola or Marburg virus known to be higher than that of the general population
  • Has received any of the following substances:
  • Investigational Ebola or Marburg vaccine in a prior clinical trial
  • Blood products within 120 days prior to HIV screening
  • Immunoglobulin within 60 days of prior to HIV screening
  • Live attenuated vaccines within 30 days prior to initial study vaccine administration
  • Investigational research agents within 30 days prior to initial study vaccine administration
  • Medically indicated subunit or killed vaccines (such as influenza, pneumococcal, or allergy treatment with antigen injections) within 14 days of study vaccine administration
  • Current anti-tuberculosis prophylaxis or therapy
  • Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within 12 weeks of enrollment, except in the following cases: use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single injection) of corticosteroids for a non-chronic condition (based on investigator clinical judgement) at least 2 weeks prior to enrollment in this study
  • History of serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain
  • Presence of idiopathic urticaria within the past 2 years
  • History of autoimmune disease or immunodeficiency
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makerere University Walter Reed Project (MUWRP) clinic

Kampala, Uganda

Location

Related Publications (1)

  • Kibuuka H, Berkowitz NM, Millard M, Enama ME, Tindikahwa A, Sekiziyivu AB, Costner P, Sitar S, Glover D, Hu Z, Joshi G, Stanley D, Kunchai M, Eller LA, Bailer RT, Koup RA, Nabel GJ, Mascola JR, Sullivan NJ, Graham BS, Roederer M, Michael NL, Robb ML, Ledgerwood JE; RV 247 Study Team. Safety and immunogenicity of Ebola virus and Marburg virus glycoprotein DNA vaccines assessed separately and concomitantly in healthy Ugandan adults: a phase 1b, randomised, double-blind, placebo-controlled clinical trial. Lancet. 2015 Apr 18;385(9977):1545-54. doi: 10.1016/S0140-6736(14)62385-0. Epub 2014 Dec 23.

    PMID: 25540891DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, EbolaMarburg Virus Disease

Interventions

Ebola Vaccines

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, ViralRNA Virus InfectionsVirus DiseasesInfectionsFiloviridae InfectionsMononegavirales InfectionsMonkey DiseasesPrimate DiseasesAnimal Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Hannah Kibuuka, MBChB, MMed, MPH

    Makerere University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2009

First Posted

October 19, 2009

Study Start

February 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

January 28, 2013

Record last verified: 2013-01

Locations

UG(1)