Ebola and Marburg Virus Vaccines

NCT00605514 | Completed Phase 1

• 2 other identifiers: 08006508-I-0065
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine if experimental vaccines to prevent Ebola virus infection and Marburg virus infection are safe and what side effects, if any, they cause. Ebola virus infection may range from mild to severe, and may cause breathing problems, severe bleeding, kidney problems and shock that can lead to death. Marburg virus infection causes an illness similar to that caused by the Ebola virus. The vaccines used in this study contain genetic material produced in the laboratory that causes the body to make a small amount of either Ebola or Marburg virus proteins. No Ebola or Marburg virus is in the vaccines. Normal healthy volunteers between 18 and 60 years of age may be eligible for this study. Participants are assigned to receive injections of either the Marburg or the Ebola vaccine. The first group of participants will receive the Marburg vaccine and the second group will receive the Ebola vaccine. The injections are given at 4-week intervals (study weeks 0, 4 and 8). They are given into a muscle with a needleless system called the Biojector(Registered Trademark) 2000. Participants keep a diary at home (on paper or electronically) for 5 days, in which they record their temperature, symptoms and any reaction at the injection site. They call a study nurse the day after vaccination to report how they feel and return to the clinic for follow-up 2 weeks after each injection (weeks 2, 6 and 10). The visits include a check of vital signs, blood and urine tests, medical history and review of medications taken. Additional visits at weeks 12, 24 and 32 include a check of vital signs, medical history and blood tests.

Conditions

Ebola Vaccines; Marburg Virus Disease; Ebola Virus Disease; Marburgvirus; Ebolavirus

Keywords

Hemorrhagic Fever; Healthy; Immunity; T-Cells; Filovirus; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• Safety (local and systemic reactogenicity, lab tests, AEs)

Secondary Outcomes (1)

• Immunogenicity (cellular and humoral immune function assays)

Interventions

VRC-EBODNA023-00-VP DRUG

VRC-MARDNA025-00-VP DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The following eligibility criteria apply to initial enrollment into the study:
• A participant must meet all of the following criteria:
• to 60 years old
• Available for clinical follow-up through Week 32
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
• Complete an AoU prior to enrollment and verbalize understanding of all questions answered incorrectly
• Able and willing to complete the informed consent process
• Willing to donate blood for sample storage to be used for future research
• In good general health without clinically significant medical history
• Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) less than 40 within the 28 days prior to enrollment
• LABORATORY CRITERIA WITHIN 28 DAYS PRIOR TO ENROLLMENT:
• Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.5 g/dL for men
• White blood cells (WBC) = 3,300-12,000 cells/mm3
• Differential either within institutional normal range or accompanied by site physician approval
• Total lymphocyte count greater than or equal to 800 cells/mm3

You may not qualify if:

• A SUBJECT WILL BE EXCLUDED IF ONE OR MORE OF THE FOLLOWING CONDITIONS APPLY:
• Women:
• Breast-feeding or planning to become pregnant during the first 32 weeks after enrollment
• SUBJECT HAS RECEIVED ANY OF THE FOLLOWING SUBSTANCES:
• Investigational Ebola vaccine in a prior clinical trial
• Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the 12 weeks prior to enrollment. \[With the exceptions that use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis, or short-acting beta-agonists in controlled asthmatics; or a short course (duration of 10 days or less, or a single injection) of corticosteroids for a non-chronic condition at least 2 weeks prior to enrollment in this study will not exclude study participation.\]
• Blood products within 120 days prior to HIV screening
• Immunoglobulin within 60 days 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, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration
• Current anti-tuberculosis prophylaxis or therapy
• SUBJECT HAS A HISTORY OF ANY OF THE FOLLOWING CLINICALLY SIGNIFICANT CONDITIONS:
• Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain
• Idiopathic urticaria within the past 2 years

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Geisbert TW, Jahrling PB. Exotic emerging viral diseases: progress and challenges. Nat Med. 2004 Dec;10(12 Suppl):S110-21. doi: 10.1038/nm1142.

  PMID: 15577929 BACKGROUND

• Meslin FX. Global aspects of emerging and potential zoonoses: a WHO perspective. Emerg Infect Dis. 1997 Apr-Jun;3(2):223-8. doi: 10.3201/eid0302.970220.

  PMID: 9204308 BACKGROUND

• Okware SI, Omaswa FG, Zaramba S, Opio A, Lutwama JJ, Kamugisha J, Rwaguma EB, Kagwa P, Lamunu M. An outbreak of Ebola in Uganda. Trop Med Int Health. 2002 Dec;7(12):1068-75. doi: 10.1046/j.1365-3156.2002.00944.x.

  PMID: 12460399 BACKGROUND

• Sarwar UN, Costner P, Enama ME, Berkowitz N, Hu Z, Hendel CS, Sitar S, Plummer S, Mulangu S, Bailer RT, Koup RA, Mascola JR, Nabel GJ, Sullivan NJ, Graham BS, Ledgerwood JE; VRC 206 Study Team. Safety and immunogenicity of DNA vaccines encoding Ebolavirus and Marburgvirus wild-type glycoproteins in a phase I clinical trial. J Infect Dis. 2015 Feb 15;211(4):549-57. doi: 10.1093/infdis/jiu511. Epub 2014 Sep 14.

  PMID: 25225676 DERIVED

MeSH Terms

Conditions

Marburg Virus Disease; Hemorrhagic Fever, Ebola; Hemorrhagic Fevers, Viral

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections; Monkey Diseases; Primate Diseases; Animal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 29, 2008
• First Posted: January 31, 2008
• Study Start: January 25, 2008
• Primary Completion: June 21, 2010
• Study Completion: June 21, 2010
• Last Updated: July 2, 2017

Record last verified: 2010-06-21

Locations

US (1)