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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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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201503001057193 |
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Date of registration:
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06/03/2015 |
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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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Ebola Vaccine Ring Vaccination Trial in Guinea
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Scientific title:
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A Randomized Trial to Evaluate Ebola Vaccine Efficacy and Safety in Guinea, West Africa-Part A: A Randomized Trial of Ring Vaccination to Evaluate Ebola Vaccine Efficacy and Safety in Guinea, West Africa. Part B- Safety and immunogenicity of VSV¿G/ZEBOV-GP among Frontline Workers |
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Date of first enrolment:
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07/03/2015 |
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Target sample size:
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21500 |
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Recruitment status: |
Complete |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1057 |
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Study type:
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Interventional |
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Study design:
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Single group: all participants receive same intervention throughout study,Randomised,Permuted block randomisation, block sizes vary between 5 and 10,Central randomization by phon/fax
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Phase:
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Not Applicable
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Countries of recruitment
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Guinea
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Contacts
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Name:
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Mandy Kader
Konde |
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Address:
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Quartier Nongo, 030 BP 518 Ratoma
Conakry
Guinea |
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Telephone:
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+224 622 40 86 48 |
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Email:
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kaderkonde@ceforpag.org |
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Affiliation:
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Ministry of Health and Hygiene Guinea |
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Name:
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Moussa
Doumbia |
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Address:
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WHO Representative Office, BP 817
Conakry
Guinea |
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Telephone:
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+224 624 827 340 |
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Email:
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moisedoum@yahoo.fr |
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Affiliation:
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CVD Mali/UMB |
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Key inclusion & exclusion criteria
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Inclusion criteria: Individuals aged 18 years or older who live in the defined vaccination ring
Children 6 to 17 years following results from phase 2 study in Gabon, and following DSMB recommendation (3 July 2015)
Exclusion criteria: History of EVD (self-report or laboratory confirmed).
Pregnancy (verbal report) or breast-feeding. Women will be offered, but not required to take, a pregnancy test.
History of having received other investigational research agents in the previous 28 days.
Self- report of clinically important immunodeficiency condition, e.g. HIV/AIDS.
History of anaphylaxis to a vaccine or vaccine component
Severe illness that makes the person bed-bound or requiring hospitalization at the time of the vaccination.
Age minimum:
6 Year(s)
Age maximum:
90 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ebola Virus Disease
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Ebola Virus Disease
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Intervention(s)
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rVSV-ZEBOV Ebola Vaccine Delayed
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rVSV-ZEBOV Ebola Vaccine Immediate
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Primary Outcome(s)
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Any probable or supsected case from which a blood sample taken is laboratory confirmed as positive for EVD, or any deceased individual with probable EVD, from which a post-mortem sample taken within 48 hours after death is laboratory confirmed as positive for Ebola Virus Disease
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Secondary Outcome(s)
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Incidense of Serious Adverse Events
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Secondary ID(s)
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RPC 721AB
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Source(s) of Monetary Support
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Wellcome Trust
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Medecins Sans Frontieres
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Public Health Agency of Canada
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Research Council of Norway
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World Health Organization
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Ethics review
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Status: Approved
Approval date: 02/03/2015
Contact:
Comité National d'Ethique pour la Recherche en Santé (CNERS)
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Status: Approved
Approval date: 17/03/2015
Contact:
World Health Orgainzation Ethics Review Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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