ClinicalTrials.gov
ClinicalTrials.gov Menu

Partnership for Research on Ebola VACcinations (PREVAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02876328
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : August 1, 2018
Sponsor:
Collaborators:
The Liberia-US Clinical Trials Partnership Program, Partnership for Research on Ebola Virus in Liberia Project (PREVAIL)
Institut National de la Santé Et de la Recherche Médicale, France
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

August 16, 2016
August 23, 2016
August 1, 2018
March 31, 2017
March 2019   (Final data collection date for primary outcome measure)
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.
Number of participants with Ebola virus glycoprotein (GP-EBOV) antibody response [ Time Frame: Measured through Month 12 ]
Complete list of historical versions of study NCT02876328 on ClinicalTrials.gov Archive Site
Frequency of serious adverse events (SAEs) [ Time Frame: Measured through Month 12 ]
SAEs as defined in the protocol
Frequency of serious adverse events (SAEs) [ Time Frame: Measured through Month 12 ]
Not Provided
Not Provided
 
Partnership for Research on Ebola VACcinations
Partnership for Research on Ebola VACcinations (PREVAC)
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.

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.

Participants will be randomized into five groups: the Ad26.ZEBOV vaccine with an MVA boost, the rVSV vaccine with or without boosting, or one of two placebo groups. At Day 0 (study entry), participants will receive the Ad26.ZEBOV vaccine, the rVSV vaccine, or placebo.

At Day 56, participants assigned to the rVSV vaccine without a boost and the two placebo groups will receive placebo. Those initially given the Ad26.ZEBOV vaccine will receive the MVA boost. Those assigned to the boosted rVSV group will receive the rVSV boost.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Ebola Virus Disease
  • Biological: Ad26.ZEBOV
    0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
    Other Name: rHAd26
  • Biological: MVA-BN-Filo
    0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
    Other Names:
    • MVA
    • MVA-mBN226B
  • Biological: rVSVΔG-ZEBOV-GP
    1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
    Other Names:
    • rVSV
    • V920
  • Biological: Placebo
    0.5 mL or 1 mL (depending upon the arm) sterile normal saline administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
  • Biological: rVSV boost
    1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
    Other Names:
    • rVSVΔG-ZEBOV-GP
    • rVSV
    • V920
  • Experimental: Ad26.ZEBOV (rHAd26) vaccine + MVA-BN-Filo (MVA) boost
    Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
    Interventions:
    • Biological: Ad26.ZEBOV
    • Biological: MVA-BN-Filo
  • Placebo Comparator: Placebo (0.5 mL)
    Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
    Intervention: Biological: Placebo
  • Experimental: rVSVΔG-ZEBOV-GP (rVSV) vaccine + placebo boost
    Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
    Interventions:
    • Biological: rVSVΔG-ZEBOV-GP
    • Biological: Placebo
  • Experimental: rVSVΔG-ZEBOV-GP (rVSV) vaccine + rVSV boost
    Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
    Interventions:
    • Biological: rVSVΔG-ZEBOV-GP
    • Biological: rVSV boost
  • Placebo Comparator: Placebo (1 mL)
    Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4500
4900
March 2019
March 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Informed consent/assent
  • Age greater than or equal to 1 year
  • Planned residency in the area of the study site for the next 12 months
  • Willingness to comply with the protocol requirements

Exclusion Criteria:

  • Fever greater than 38º Celsius
  • History of EVD (self-report)
  • Pregnancy (a negative urine pregnancy test is required for females of child-bearing potential, i.e., females who have experienced menarche or who are aged 14 years and older)
  • Positive HIV test for participants less than 18 years of age
  • Reported current breast-feeding
  • Prior vaccination against Ebola (self-report)
  • Any vaccination in the past 28 days or planned within the 28 days after randomization (initial vaccination)
  • In the judgement of the clinician, any clinically significant acute/chronic condition that would limit the ability of the participant to meet the requirements of the study protocol
Sexes Eligible for Study: All
1 Year and older   (Child, Adult, Older Adult)
Yes
Guinea,   Liberia,   Mali,   Sierra Leone
 
 
NCT02876328
C15-33
PREVACEBL3005 ( Other Identifier: LSHTM )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
  • The Liberia-US Clinical Trials Partnership Program, Partnership for Research on Ebola Virus in Liberia Project (PREVAIL)
  • Institut National de la Santé Et de la Recherche Médicale, France
  • London School of Hygiene and Tropical Medicine
Principal Investigator: Yazdan Yazdanpannah Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Abdoul Habib Beavogui Centre de Formation et de Recherche en Santé Rurale de Mafèrinyah
Principal Investigator: Mark Kieh Redemption Hospital
Principal Investigator: Bailah Leigh University of Sierra Leone
National Institute of Allergy and Infectious Diseases (NIAID)
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP