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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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12 December 2020 |
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Main ID: |
NCT02378753 |
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Date of registration:
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19/02/2015 |
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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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STRIVE (Sierra Leone Trial to Introduce a Vaccine Against Ebola)
STRIVE |
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Scientific title:
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[rVSV?G-ZEBOV] Ebola Prevention Vaccine Evaluation in Sierra Leone |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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8651 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02378753 |
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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: None (Open Label).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Sierra Leone
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Contacts
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Name:
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Mohamed Samai, MBChB,PhD |
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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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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age 18 years or older.
2. Member of target population at the 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.
Exclusion Criteria:
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
<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 = 38.0°C (100.4°F) at time of vaccination.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hemorrhagic Fever, Ebola
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Intervention(s)
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Biological: rVSV?G-ZEBOV
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Primary Outcome(s)
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Number of Participants With Occurrence of Serious Adverse Events During the 6 Months Following the Vaccination
[Time Frame: 6 months following vaccination]
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Laboratory-confirmed Ebola (Study Diagnostics)
[Time Frame: > 21 days following vaccination]
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Secondary Outcome(s)
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Death Due to Laboratory-confirmed Ebola
[Time Frame: 6 months following vaccination]
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Number of Participants With Occurrence of Solicited and Unsolicited AEs During the 28 Days Following the Vaccination or Enrollment
[Time Frame: During 28 days following vaccination]
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Ebola Confirmed by Non-study or Study Diagnostics
[Time Frame: 6 months following vaccination]
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Number of Participants With Occurrence of Solicited Injection-site and Systemic Reactogenicity Signs and Symptoms, Including Fever, on Vaccination Day and During the 7 Days Following the Vaccination or Enrollment.
[Time Frame: Vaccination day and for 7 days following vaccination]
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Suspected, Probable or Laboratory-confirmed Ebola
[Time Frame: 6 months following vaccination]
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Secondary ID(s)
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CDC-NCIRD-6689
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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