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Partnership for Research on Ebola VACcinations (PREVAC)

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ClinicalTrials.gov Identifier: NCT02876328
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : October 24, 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)

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.

Condition or disease Intervention/treatment Phase
Ebola Virus Disease Biological: Ad26.ZEBOV Biological: MVA-BN-Filo Biological: rVSVΔG-ZEBOV-GP Biological: Placebo Biological: rVSV boost Phase 2

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, 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Partnership for Research on Ebola VACcinations (PREVAC)
Actual Study Start Date : March 31, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
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.
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

Placebo Comparator: Placebo (0.5 mL)
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
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

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.
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

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.
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: 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

Placebo Comparator: Placebo (1 mL)
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Frequency of serious adverse events (SAEs) [ Time Frame: Measured through Month 12 ]
    SAEs as defined in the protocol



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876328


Locations
Guinea
Centre national de formation et de recherche en santé rurale (Maferyniah) Recruiting
Conakry, Guinea
Contact: Dr. Abdoul Habib Beavogui    +224 628045352    beavoguia_h@yahoo.com   
Landreah Recruiting
Conakry, Guinea
Contact: Judith Katoudi    +224625258456    ldh.coordo.prevac@guinee.alima.ngo   
Liberia
The Redemption Hospital Recruiting
Monrovia, Liberia
Contact: Sarah Brown    +231886585479    brownsarah2006@yahoo.com   
Mali
Centre pour le Développement des Vaccins (CVD) Recruiting
Bamako, Mali
Contact: Sambo O. Sow    223 7634 8947    ssow@som.umaryland.edu   
University Clinical Research Center (UCRC) Recruiting
Bamako, Mali
Contact: Seydou Doumbia    223 76 46 13 39    sdoumbi@gmail.com   
Sierra Leone
Mambolo Clinic Recruiting
Kapesseh, Sierra Leone
Contact: Bailah Leigh    23276693102    bailahleigh@yahoo.co.uk   
Sponsors and Collaborators
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
Investigators
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

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02876328     History of Changes
Other Study ID Numbers: C15-33
PREVACEBL3005 ( Other Identifier: LSHTM )
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Ebola Vaccine

Additional relevant MeSH terms:
Hemorrhagic Fever, Ebola
Virus Diseases
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs