cAd3-Marburg Vaccine in Healthy Adults (NCT03475056) | Clinical Trial Compass
CompletedPhase 1
cAd3-Marburg Vaccine in Healthy Adults
United States40 participantsStarted 2018-10-09
Plain-language summary
RV 507 was a Phase I, open-label study to examine the safety, tolerability and immunogenicity of an investigational Marburg vaccine given by intramuscular (IM) injection to healthy adults. The study was a dose escalation of VRC-MARADC087-00-VP, a chimpanzee adenovirus serotype 3 (cAd3) vector vaccine, which encodes wild type (WT) glycoprotein (GP) from Marburgvirus.
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. Proof of identity includes a valid U.S. government-issued or state-issued photo identification (ID) such as a driver's license, military ID, or U.S. passport.
. Able and willing to provide a personal mobile phone number or home phone number at which the participant can be reliably contacted. Participants will be contacted primarily for study visit 2A (Appendix 1), as a reminder of an upcoming visit, and after missed visits for rescheduling purposes.
. Able and willing to complete the informed consent process and demonstrate understanding with a passing score (90% or greater) on the Assessment of Understanding (AOU) by the third attempt.
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-Marburg 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-Marburg 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-Marburg 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 IDNCT03475056
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. In good general health without clinically significant medical history.
. Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) ≤ 40 within the 56 days prior to enrollment.
. Laboratory Criteria within 56 days prior to enrollment:
Exclusion criteria
. Investigational Ebola or Marburg vaccine in a prior clinical trial or prior receipt of a cAd3 vectored investigational vaccine.
. Immunosuppressive medications within 2 weeks prior to enrollment.
. 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.