Phase 3
Completed N=8,651
STRIVE (Sierra Leone Trial to Introduce a Vaccine Against Ebola)
Hemorrhagic Fever, Ebola
Source: ClinicalTrials.gov NCT02378753 ↗
Enrolled (actual)
8,651
Serious AEs
1.3%
Results posted
Apr 2018
Primary outcomePrimary: Laboratory-confirmed Ebola (Study Diagnostics) — 0; 0 Participants
◆ Published Evidence
Established
33citations · ~6 / year
Pregnancy Outcomes among Women Receiving rVSVΔ-ZEBOV-GP Ebola Vaccine during the Sierra Leone Trial to Introduce a Vaccine against Ebola.
Summary
The 2014 outbreak of Ebola in West Africa is the largest in recorded history with widespread and intense transmission in Guinea, Liberia, and Sierra Leone. The high infectivity of blood and secretions, lack of appropriate personal protective equipment (PPE) and challenges in following infection control and prevention protocols put healthcare workers at high risk during outbreaks, and direct contact with the bodies of deceased Ebola victims can also sustain community transmission. This study will accelerate introduction and use of monovalent recombinant vesicular stomatitis virus Ebola vaccine (rVSVΔG-ZEBOV) among healthcare workers and frontline personnel involved in the Ebola outbreak response in Sierra Leone, while concurrently evaluating the safety and efficacy 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.
Linked Publications (5)
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Pregnancy Outcomes among Women Receiving rVSVΔ-ZEBOV-GP Ebola Vaccine during the Sierra Leone Trial to Introduce a Vaccine against Ebola.
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Immunogenicity of rVSVΔG-ZEBOV-GP Ebola vaccine (ERVEBO®) in African clinical trial participants by age, sex, and baseline GP-ELISA titer: A post hoc analysis of three Phase 2/3 trials.
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Clinical Surveillance and Evaluation of Suspected Ebola Cases in a Vaccine Trial During an Ebola Epidemic: The Sierra Leone Trial to Introduce a Vaccine Against Ebola.
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Participant Retention in a Randomized Clinical Trial in an Outbreak Setting: Lessons From the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE).
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Operationalizing International Regulatory Standards in a Limited-Resource Setting During an Epidemic: The Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE) Experience.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Laboratory-confirmed Ebola (Study Diagnostics) |
0; 0 | — |
| PRIMARY Number of Participants With Occurrence of Serious Adverse Events During the 6 Months Following the Vaccination |
54; 47 | — |
| SECONDARY Death Due to Laboratory-confirmed Ebola |
0; 0 | — |
| SECONDARY Ebola Confirmed by Non-study or Study Diagnostics |
0; 0 | — |
| SECONDARY Suspected, Probable or Laboratory-confirmed Ebola |
27; 17 | — |
| SECONDARY 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. |
202; 76 | — |
| SECONDARY Number of Participants With Occurrence of Solicited and Unsolicited AEs During the 28 Days Following the Vaccination or Enrollment |
203; 117; 101; 27 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older.
- 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.
- Reasonably anticipates living in Sierra Leone for the 18-24 weeks following enrollment.
- Reachable by phone throughout the 6 month post-vaccination safety follow-up period.
- Willing to adhere to personal protective equipment (PPE) and infection control recommendations.
- Able and willing to complete the informed consent process and study procedures.
- Willing to receive vaccine in either the immediate or the deferred trial arms, according to random assignment.
Exclusion Criteria
- History of Ebola (self-report).
- Prior receipt of experimental Ebola or Marburg vaccine.
- History of human immunodeficiency virus (HIV) or clinically important immunodeficiency (self-report).
- Any history of allergy or anaphylaxis to prior vaccines
- Breast-feeding an infant or child.
- Any reason the investigator suspects that data collected from this person would be incomplete or of poor quality.
- Current pregnancy (a negative urine pregnancy test is required for women participants <50 years of age who self-report as not pregnant).
- Currently being followed for known exposure to Ebola.
- Known experimental research agents or other vaccine within 28 days (4 weeks) before vaccination.
- Fever ≥ 38.0°C (100.4°F) at time of vaccination.
Data sourced from ClinicalTrials.gov (NCT02378753) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.