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 range18 Years – 50 Years
SexALL
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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.
✓. 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.
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)