Ebola and Marburg Virus Vaccines (NCT00605514) | Clinical Trial Compass
CompletedPhase 1
Ebola and Marburg Virus Vaccines
United States20 participantsStarted 2008-01-25
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 18 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
Exclusion criteria
✕. Breast-feeding or planning to become pregnant during the first 32 weeks after enrollment
What they're measuring
1
Safety (local and systemic reactogenicity, lab tests, AEs)
Trial details
NCT IDNCT00605514
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. 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