Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201503001057193 Date of Approval: 06/03/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ebola Vaccine Ring Vaccination Trial in Guinea
Official scientific title 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
Brief summary describing the background and objectives of the trial There is an urgent need for efficacy and safety testing of the unlicensed vaccine candidates. Since there is no established correlate of protection in humans, efficacy trials in settings of on-going EVD transmission are necessary. EVD spreads by direct contact with body fluids of symptomatic patients. Ring vaccination consists of targeted vaccination of all individuals living in the vicinity of a newly diagnosed case and their contacts, and can create a buffer of immune persons to prevent further spread of the infection. Simulation and field studies show that ring vaccination around new cases may be effective and contain outbreaks of infectious diseases with relatively low reproduction numbers. Standard randomized controlled trials in the general population, or trials of geographically defined clusters not linked to an index case would require large sample sizes and long study durations. Inspired by the experience with smallpox, the ring vaccination study proposed here will be done in a population at increased risk of infection and provide answers in a relatively short time. Primary objective To assess vaccine efficacy against laboratory-confirmed Ebola virus disease (EVD) by performing a clinical trial comparing immediate versus delayed ring vaccination. Secondary objectives To assess overall vaccine effectiveness (cumulative incidence) in preventing laboratory-confirmed EVD at the level of the ring after 84 days of follow-up. To assess vaccine efficacy against death from laboratory-confirmed EVD. To assess vaccine efficacy against probable and suspected EVD. To evaluate vaccine safety by assessing SAE over 84 days.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ebola Virus Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 07/03/2015
Actual trial start date 07/03/2015
Anticipated date of last follow up 31/08/2015
Actual Last follow-up date 20/01/2016
Anticipated target sample size (number of participants) 21500
Actual target sample size (number of participants) 8851
Recruitment status Completed
Publication URL http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(15)61117-5.pdf
Secondary Ids Issuing authority/Trial register
RPC 721AB World Health Organization
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Randomised Permuted block randomisation, block sizes vary between 5 and 10 Central randomization by phon/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group rVSV-ZEBOV Ebola Vaccine Immediate single dose not applicable Ebola candidate vaccine 100
Experimental Group rVSV-ZEBOV Ebola Vaccine Delayed single dose not applicable Ebola candidate vaccine 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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) 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. 6 Year(s) 90 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/03/2015 Comité National d'Ethique pour la Recherche en Santé (CNERS)
Ethics Committee Address
Street address City Postal code Country
Conakry Conakry Guinea
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/03/2015 World Health Orgainzation Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
20 Avenue Appiah Geneva 1211 Switzerland
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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 through out the study
Secondary Outcome Incidense of Serious Adverse Events through out the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ferocariah Yaroworiyah Moussaya Guinea
Boke Kamsar Tamarasi Guinea
Kindia Kindia Guinea
Nasser village Coyah Guinea
Matoto Conakry Guinea
University Teaching Hospital Conakry Conakry Guinea
Bonfe Village Coyah Guinea
FUNDING SOURCES
Name of source Street address City Postal code Country
World Health Organization 20 Av Appia Geneva 27 1211 Switzerland
Wellcome Trust 215 Euston Road London NW12BE United Kingdom
Research Council of Norway Drammensveien 288 Oslo 0283 Norway
Medecins Sans Frontieres Rue Dupr; 94 Brussels 1090 Belgium
Public Health Agency of Canada 130 Colonnade Road Ottawa K1A0K9 Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor World Health Organization 20 Av Appia Geneva 27 1211 Switzerland Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Ministry of Health Guinea Conakry Conakry Guinea
Medecins Sans Frontieres Epicentre 55 rue Crozatier Paris 75012 France
Norwegian Institute of Public Health PO Box 4404 Nydalen Oslo N/0403 Norway
Institute of ssocial and preventive medicine and centre for clinical trials University of Bern Finkenhubelweg 11 Bern CH-3012 Switzerland
London School of Hygiene and Tropical Medicine Keppel Street London WC1E 7HT United Kingdom
University of Florida 22 Buckmand Drive, 452 Dauer Hall Gainsville FL 32611 United States of America
Centre for Vaccine Development, Mali/Maryland 655 W Baltimore Street Baltimore MD21201 United States of America
Public Health England 133-155 Waterloo House London SE18UG United Kingdom
Public Health Agency of Canada 130 Colonnade Road Ottawa K1A0K9 Canada
NewLink/Merck 2503 South Loop Drive Ames Iowa 50010 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abubakar Soumah aboubacar.soumah@epicentre.msf.org +224622862549 Lambanyi ¿ Commune de Ratoma (Conakry), Guinéen
City Postal code Country Position/Affiliation
Conakry Guinea MSF Epicentre
Role Name Email Phone Street address
Public Enquiries Mandy Kader Konde kaderkonde@ceforpag.org +224 622 40 86 48 Quartier Nongo, 030 BP 518 Ratoma
City Postal code Country Position/Affiliation
Conakry Guinea Ministry of Health and Hygiene Guinea
Role Name Email Phone Street address
Scientific Enquiries Moussa Doumbia moisedoum@yahoo.fr +224 624 827 340 WHO Representative Office, BP 817
City Postal code Country Position/Affiliation
Conakry Guinea CVD Mali/UMB
REPORTING
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Changes to trial information