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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02876328
Recruitment Status : Active, not recruiting
First Posted : August 23, 2016
Last Update Posted : July 29, 2020
Sponsor:
Collaborators:
Partnership for Research on Ebola Virus in Liberia (PREVAIL)
Institut National de la Santé Et de la Recherche Médicale, France
London School of Hygiene and Tropical Medicine
European and Developing Countries Clinical Trials Partnership (EDCTP)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE August 16, 2016
First Posted Date  ICMJE August 23, 2016
Last Update Posted Date July 29, 2020
Actual Study Start Date  ICMJE March 31, 2017
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
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 Measures  ICMJE
 (submitted: August 18, 2016)
Number of participants with Ebola virus glycoprotein (GP-EBOV) antibody response [ Time Frame: Measured through Month 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2019)
Frequency of serious adverse events (SAEs) [ Time Frame: Measured through Month 60 ]
SAEs as defined in the protocol
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
Frequency of serious adverse events (SAEs) [ Time Frame: Measured through Month 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Partnership for Research on Ebola VACcinations
Official Title  ICMJE 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 Description

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, 12, 24, 36, 48, and 60. Study visits may include blood collection and other assessments.

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Ebola Virus Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Badio M, Lhomme E, Kieh M, Beavogui AH, Kennedy SB, Doumbia S, Leigh B, Sow SO, Diallo A, Fusco D, Kirchoff M, Termote M, Vatrinet R, Wentworth D, Esperou H, Lane HC, Pierson J, Watson-Jones D, Roy C, D'Ortenzio E, Greenwood B, Chêne G, Richert L, Neaton JD, Yazdanpanah Y; PREVAC study team. Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries. Trials. 2021 Jan 23;22(1):86. doi: 10.1186/s13063-021-05035-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 21, 2019)
4789
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2016)
4900
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Guinea,   Liberia,   Mali,   Sierra Leone
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02876328
Other Study ID Numbers  ICMJE C15-33
PREVACEBL3005 ( Other Identifier: LSHTM )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE
  • Partnership for Research on Ebola Virus in Liberia (PREVAIL)
  • Institut National de la Santé Et de la Recherche Médicale, France
  • London School of Hygiene and Tropical Medicine
  • European and Developing Countries Clinical Trials Partnership (EDCTP)
Investigators  ICMJE
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
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date July 2020

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