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.: PACTR201502001037220 Date of Registration: 16/02/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title STRIVE: Sierra Leone Trial to Introduce a Vaccine against Ebola
Official scientific title [rVSV¿G-ZEBOV] Ebola Prevention Vaccine Evaluation in Sierra Leone
Brief summary describing the background and objectives of the trial The Ebola outbreak was confirmed in March 2014 with widespread and intense transmission in Guinea, Liberia, and Sierra Leone. This study will accelerate introduction and use of monovalent recombinant vesicular stomatitis virus Ebola vaccine (rVSVdeltaG-ZEBOV) among healthcare workers and frontline personnel involved in the Ebola outbreak response in Sierra Leone, while concurrently evaluating the efficacy and safety of the vaccine. This is an unblinded, randomized trial with phased vaccine introduction in the target population. Participation in the study will be voluntary and open to adults 18 years of age and older who are at high risk of exposure to Ebola infection through their daily work and who work in a selected study area. Staff members involved in this study are also eligible to receive the vaccine under this protocol. Eligible participants within a healthcare facility or frontline team will be enrolled and individually randomized to either immediate or deferred vaccination. A single dose of rVSVdeltaG-ZEBOV will be administered intramuscularly. Immediate vaccination is defined as vaccination within 7 days of enrollment and deferred vaccination is defined as vaccination at the end of an 18-24 week follow-up period. Participants will not be blinded to the randomized assignment of immediate or deferred vaccination. All enrolled participants will have the opportunity to receive rVSVdeltaG-ZEBOV by the end of the study. Enrollment and vaccination will be phased over time. Ebola events that occur during the 18-24 week post-enrollment will be included in the VE analysis, with the immediate vaccination arm contributing vaccinated follow-up time and the deferred vaccination arm contributing unvaccinated follow-up time. All participants, regardless of randomized assignment, will be followed for 6 months after vaccination to monitor for safety of rVSVdeltaG-ZEBOV.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ebola,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Ebola
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 07/03/2015
Actual trial start date 09/04/2015
Anticipated date of last follow up 01/09/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 6000
Actual target sample size (number of participants) 8651
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
CDC IRB #6689 Human Research Protection Office, Centers for Disease Control and Prevention
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
Parallel: different groups receive different interventions at same time during study Randomised Sequence of potential assignments to either immediate vaccination or deferred vaccination arm will be generated. Random vaccination assignments will be generated by statistician and concealed from study staff. Assignments will be disclosed to participants following enrollment. Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Sequence of potential assignments to either immediate vaccination or deferred vaccination arm will be generated. Random vaccination assignments will be generated by statistician and concealed from study staff. Assignments will be disclosed to participants following enrollment. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Immediate vaccination with rVSVdeltaG-ZEBOV (BPSC-1001) 2 x 10^7 PFU Single intramuscular injection Monovalent recombinant vesicular stomatitis virus expressing the envelope glycoprotein of Ebola virus Zaire (rVSVdeltaG-ZEBOV); immediate vaccination following enrollment 3000
Experimental Group Deferred vaccination with rVSVdeltaG-ZEBOV (BPSC-1001) 2 x 10^7 PFU Single intramuscular injection Monovalent recombinant vesicular stomatitis virus expressing the envelope glycoprotein of Ebola virus Zaire (rVSVdeltaG-ZEBOV); deferred vaccination 18-24 weeks following enrollment 3000
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Age 18 years or older. 2.Member of target population at time of enrollment: -Active worker in an Ebola care, holding, or treatment center (may include physicians, nurses, nurse aides, lab technicians, pharmacists, pharmacy technicians, cleaners, and security and administrative staff); -Active worker in a facility providing non-Ebola-related healthcare (may include physicians, nurses, nurse aides, lab technicians, pharmacists, pharmacy technicians, cleaners, and security and administrative staff); -Active frontline worker in one of the following job categories: surveillance team, ambulance team, burial worker or worker responsible for swabbing deceased persons) 3.Reasonably anticipates living in Sierra Leone for the 18-24 weeks following enrollment. 4.Reachable by phone throughout the 6 month post-vaccination safety follow-up period. 5.Willing to adhere to personal protective equipment (PPE) and infection control recommendations. 6.Able and willing to complete the informed consent process and study procedures. 7.Willing to receive vaccine in either the immediate or the deferred trial arms, according to random assignment. 1.History of Ebola (self-report). 2.Prior receipt of experimental Ebola or Marburg vaccine. 3.History of human immunodeficiency virus (HIV) or clinically important immunodeficiency (self-report). 4.Any history of allergy or anaphylaxis to prior vaccines. 5.Breast-feeding an infant or child. 6.Any reason the investigator suspects that data collected from this person would be incomplete or of poor quality. 7.Current pregnancy (a negative urine pregnancy test is required for women participants younger than 50 years of age who self report as not pregnant). 8.Currently being followed for known exposure to Ebola. 9.Known experimental research agents or other vaccine within 28 days (4 weeks) before vaccination. 10.Fever greater than or equal to 38.0°C (greater than or equal to 100.4°F) at time of vaccination. 18 Year(s) 100 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 03/02/2015 Sierra Leone Ethics and Scientific Review Committee
Ethics Committee Address
Street address City Postal code Country
Nr. Ward 10, Connaught Hospital Freetown Sierra Leone
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 U.S. Centers for Disease Control and Prevention Human Research Protection Office
Ethics Committee Address
Street address City Postal code Country
1600 Clifton Road, MS D-73 Atlanta United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Occurrence of SAEs during the 6 months following vaccination Through 6 months following vaccination.
Primary Outcome Laboratory-confirmed Ebola (study diagnostics) Greater than 21 days following vaccination
Secondary Outcome Death due to laboratory-confirmed Ebola (study diagnostics) Through 6 months following vaccination
Secondary Outcome Ebola confirmed by non-study or study diagnostics Through 6 months following vaccination
Secondary Outcome Suspected, probable, or laboratory-confirmed Ebola Through 6 months following vaccination
Secondary Outcome Occurrence of solicited injection-site and systemic reactogenicity signs and symptoms, including fever, on vaccination day and during the 7 days following the vaccination Through 7 days following vaccination
Secondary Outcome Occurrence of solicited and unsolicited AEs during the 28 days following the vaccination Through 28 days following vaccination
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Port Loko St John of God Nursing School - Lunsar Port Loko Sierra Leone
Port Loko District Hospital Port Loko Sierra Leone
Tonkolili Magburaka District Hospital Tonkolili Sierra Leone
Port Loko St John of God - Kaffu Bullom Port Loko Sierra Leone
Bombali Holy Spirit Hospital Makeni Sierra Leone
Western Area -Rural COMAHS Library Jui Sierra Leone
Western Area Connaught Hospital Freetown Sierra Leone
FUNDING SOURCES
Name of source Street address City Postal code Country
U.S. Centers for Disease Control and Prevention (CDC) 1600 Clifton RD Atlanta 30333 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor U.S. Centers for Disease Control and Prevention 1600 Clifton RD Atlanta 30333 United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
College of Medicine and Allied Health Sciences, University of Sierra Leone A. J. Momoh Street, Tower Hill Freetown Sierra Leone
Dept. of Health & Human Services/Office of the Assistant Secretary for Preparedness & Response/Biomedical Advanced Research & Development Authority 200 Independence Avenue, S.W. Washington, D.C. 20201 United States of America
eHealth Africa 117 A Wilkinson Road (1st Floor) Freetown Sierra Leone
Sierra Leone Ministry of Health and Sanitation Freetown Sierra Leone
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Samai dhmsamai@yahoo.com +23278841262 College of Medicine and Allied Health Sciences, University of Sierra Leone
City Postal code Country Position/Affiliation
Freetown Sierra Leone Principal Investigator
Role Name Email Phone Street address
Public Enquiries Munda Rogers registrycomahs@gmail.com +23277440038 College of Medicine and Allied Health Sciences, University of Sierra Leone
City Postal code Country Position/Affiliation
Freetown Sierra Leone Public Relations Officer
Role Name Email Phone Street address
Scientific Enquiries Durodamil Radcliffe Lisk durodamil@yahoo.co.uk +23278603289 College of Medicine and Allied Health Sciences, University of Sierra Leone
City Postal code Country Position/Affiliation
Freetown Sierra Leone Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information