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 range18 Years – 50 Years
SexALL
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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.
✓. 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.
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)