Evaluating an Ebola and a Marburg Vaccine in Uganda (NCT00997607) | Clinical Trial Compass
CompletedPhase 1
Evaluating an Ebola and a Marburg Vaccine in Uganda
Uganda108 participantsStarted 2010-02
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Inve…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of Ebola vaccine, as seen in local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse experiences
Timeframe: Measured at 11 or more visits over 2 years
2
Safety of Marburg vaccine, as seen in local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse experiences
Timeframe: Measured at 11 or more visits over 2 years
Trial details
NCT IDNCT00997607
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)