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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 December 2023 |
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Main ID: |
NCT02876328 |
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Date of registration:
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16/08/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Partnership for Research on Ebola VACcinations
PREVAC |
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Scientific title:
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Partnership for Research on Ebola VACcinations (PREVAC) |
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Date of first enrolment:
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March 27, 2017 |
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Target sample size:
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4789 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02876328 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Guinea
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Liberia
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Mali
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Sierra Leone
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Contacts
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Name:
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Yazdan Yazdanpannah |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut National de la Santé Et de la Recherche Médicale, France |
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Name:
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Seydou Doumbia |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Sciences, Techniques and Technologies of Bamako |
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Name:
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Mark Kieh |
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Address:
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Telephone:
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Email:
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Affiliation:
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Redemption Hospital |
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Name:
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Abdoul Habib Beavogui |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre de Formation et de Recherche en Santé Rurale de Mafèrinyah |
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Name:
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Samba O. Sow |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre pour le Developpement des Vaccins |
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Name:
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Bailah Leigh |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Sierra Leone |
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Name:
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Stephen B. Kennedy |
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Address:
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Telephone:
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Email:
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Affiliation:
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Redemption Hospital |
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Key inclusion & exclusion criteria
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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
Inclusion Criteria for Revaccination Post 12 Month Visit:
- Participants who received the placebo
- Participants who received an incomplete Ad26.ZEBOV/MVA-BN-Filo vaccine strategy
Temporary Exclusion Criteria for Revaccination Post 12 Month Visit:
- Fever greater than 38º Celsius
- 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)
- Reported current breast-feeding (self-report)
- Any vaccination in the past 28 days or planned within the 28 days after trial
vaccination
Exclusion Criteria for Revaccination Post 12 Month Visit:
- EVD notified in the electronic case report form
- For minor participants: change in HIV status since enrollment (self-report)
- Previous Ebola vaccination outside of the study including incomplete vaccine
strategies
- Known medical history or significant risk factors for a thrombotic and/or
thrombocytopenic event (for participants who will receive the Ad26.ZEBOV or
MVA-BN-Filo vaccine)
Age minimum:
1 Year
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ebola Virus Disease
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Intervention(s)
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Biological: rVSV boost
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Biological: rVSV?G-ZEBOV-GP
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Biological: Ad26.ZEBOV
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Biological: MVA-BN-Filo
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Biological: Placebo
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Primary Outcome(s)
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Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response
[Time Frame: Measured through Month 12]
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Secondary Outcome(s)
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Frequency of Serious Adverse Events (SAEs)
[Time Frame: Measured through Month 60]
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Number of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response
[Time Frame: Measured through Month 60]
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Secondary ID(s)
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C15-33
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PREVACEBL3005
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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