Clinical Trial: Partnership for Research on Ebola VACcinations

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Partnership for Research on Ebola VACcinations (PREVAC)

Brief Summary: The purpose of this study is to evaluate the safety and immunogenicity of three vaccine strategies that may prevent Ebola virus disease (EVD) events in children and adults. Participants will receive either the Ad26.ZEBOV (rHAd26) vaccine with a MVA-BN-Filo (MVA) boost, or the rVSVΔG-ZEBOV-GP (rVSV) vaccine with or without boosting, or placebo.

Detailed Summary:

The purpose of this study is to evaluate the safety and immunogenicity of two Ebola virus disease (EVD) vaccines, Ad26.ZEBOV (rHAd26) and rVSVΔG-ZEBOV-GP (rVSV), in children and adults. These vaccines will be studied using three different strategies: the rHAd26 vaccine plus a MVA-BN-Filo (MVA) boost, and the rVSV vaccine with or without boosting.

During the initial phase of the study, people older than 12 years of age will be enrolled. At Day 0 (study entry), participants will be randomly assigned to receive the Ad26.ZEBOV vaccine or placebo. At Day 56, participants who received the Ad26.ZEBOV vaccine will receive an MVA boost and participants who received placebo will receive placebo again.

When additional safety data for the current lot of the rVSV vaccine becomes available from an ongoing trial in the United States, or when a new lot of the rVSV vaccine becomes available, the trial will be expanded to include the rVSV vaccine strategies and matching placebo.

Once this occurs, people 1 year of age or older will be randomized into five groups: the two groups described above, the rVSV vaccine with or without boosting, or a second placebo group. At Day 56, participants who received the rVSV vaccine will receive either an rVSV boost or placebo and participants who received placebo will receive placebo again.

Additional study visits will occur on Days 7, 14, 28, and 63, and at Months 3, 6, and 12. Study follow-up may continue for up to 5 years. Study visits may include blood collection and other assessments.

Some participants may take part in substudies, which will include blood or saliva collection.


Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome: Number of participants with Ebola virus glycoprotein (GP-EBOV) antibody response [ Time Frame: Measured through Month 12 ]

Antibodies to the Ebola virus glycoprotein will be measured with the Filovirus Animal Nonclinical Group (FANG) ELISA assay if available. Other assays may also be used.


Original Primary Outcome: Number of participants with Ebola virus glycoprotein (GP-EBOV) antibody response [ Time Frame: Measured through Month 12 ]

Current Secondary Outcome: Frequency of serious adverse events (SAEs) [ Time Frame: Measured through Month 12 ]

SAEs as defined in the protocol


Original Secondary Outcome: Frequency of serious adverse events (SAEs) [ Time Frame: Measured through Month 12 ]

Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: August 16, 2016
Date Started: March 31, 2017
Date Completion: March 2019
Last Updated: April 21, 2017
Last Verified: April 2017