A phase Ib, open-label, clinical trial to evaluate the safety, tolerability and immunogenicity of the Ebola chimpanzee adenovirus vector vaccines, vrc-eboadc069-00-vp (Cad3-Ebo) and vrc-eboadc076-00-vp (Cad3-Eboz), in healthy adults in Kampala, Uganda

Overview

No summary available.

Registry

who.int

Start Date

December 3, 2014

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. 18 to 65 years old.
•2\. Available for clinical follow\-up through Week 48 after enrollment.
•3\. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
•4\. Must be willing to be taken home at enrollment visit and allow home visits if participant does not keep appointments
•5\. Must complete an Assessment of Understanding (AoU) prior to enrollment by answering 9 out of 10 questions at least once in 3 attempts.
•6\. Able to read (English or Luganda) and willing to complete the informed consent process.
•7\. Willing to donate blood for sample storage to be used for future research.
•8\. In good general health without clinically significant medical history.
•9\. 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:

•1\.Investigational Ebola or Marburg vaccine (other than the Ebola DNA vaccine delivered in RV 247\) in a prior clinical trial or prior receipt of a cAd3 adenoviral vectored investigational vaccine.
•2\. 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.
•3\. Blood products within 112 days (16 weeks) prior to enrollment.
•4\. Investigational research agents within 28 days (4 weeks) prior to enrollment.
•5\. Live attenuated vaccines within 28 days (4 weeks) prior to enrollment.
•6\. Subunit or killed vaccines within 14 days (2 weeks) prior to enrollment.
•7\. Current anti\-tuberculosis prophylaxis or therapy.
•Female\-specific criteria:
•8\. Woman who is breast\-feeding or planning to become pregnant during the first 24 weeks after study vaccine administration.
•Volunteer has a history of any of the following clinically significant conditions: