Ebola Sudan Chimpanzee Adenovirus Vector Vaccine in Healthy Adults
Uganda40 participantsStarted 2019-07-02
Plain-language summary
RV 508 was a Phase I, open-label, dose-escalation study to examine the safety, tolerability and immunogenicity of an investigational Ebola vaccine in healthy adults. VRC-EBOADC086-00-VP, a chimpanzee adenovirus serotype 3 vector-based Ebola vaccine, encodes wild type (WT) glycoprotein (GP) from the Sudan strain of Ebolavirus and is administered intramuscularly (IM).
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
. 18 to 50 years old.
. Available for clinical follow-up through Week 48 after enrollment.
. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
. Able and willing to provide fingerprints and have their photographs taken including injection site photographs.
. Must allow home visits
. Must complete an Assessment of Understanding (AoU) prior to enrollment by answering 9 out of 10 questions at least once in 3 attempts.
. Able to read (English or Luganda) and willing to complete the informed consent process.
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
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-EBO S Vaccine Administration
Timeframe: 7 days after study product administration
2
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-EBO S Vaccine Administration
Timeframe: 7 days after study product administration
3
Total Number of Participants Reporting Any Reactogenicity Signs and Symptoms for 7 Days After the cAd3-EBO S Vaccine Administration
Timeframe: 7 days after study product administration
4
Number of Participants With Abnormal Laboratory Measures of Safety
Timeframe: Through 48 weeks after study product administration
5
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs)
Timeframe: Through 28 days after study product administration
6
Number of Participants With Serious Adverse Events (SAEs)
Timeframe: Through 48 weeks after study product administration
Trial details
NCT IDNCT04041570
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. In good general health without clinically significant medical history.
Exclusion criteria
. Investigational Ebola or Marburg vaccine in a prior clinical trial or prior receipt of a cAd3 adenoviral vectored investigational vaccine.
. Chronic use of immunomodulators and systemic glucocorticoids in daily doses of glucocorticoid equivalence \> 20 mg of prednisolone, for periods exceeding 10 days. Non-steroidal anti-inflammatory drugs \[NSAIDS\] are permitted. Participants that have used less than the stated glucocorticoid dose may still be excluded at the Investigator's discretion.
. Blood products within 112 days (16 weeks) prior to enrollment.
. Investigational research agents within 28 days (4 weeks) prior to enrollment.
. Live attenuated vaccines within 28 days (4 weeks) prior to enrollment.
. Subunit or killed vaccines within 14 days (2 weeks) prior to enrollment.
. Current anti-tuberculosis prophylaxis or therapy.
. Woman who is pregnant, breast-feeding or planning to become pregnant during the first 24 weeks after study vaccine administration.