Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02378753 | STRIVE (Sierra Leone Trial to Introduce a Vaccine Against Ebola) | PHASE2 | COMPLETED | 8,651 | — | — | Apr 1, 2015 | Dec 5, 2016 | Apr 5, 2018 | 5 | Sierra Leone |
Incidence of Ebola confirmed by the STRIVE study laboratory in each treatment group during the Randomized Portion of the trial. For the vaccine efficacy endpoint, all enrolled participants in both arms were followed for 18-24 weeks after enrollment (after which point participants in the deferred cohort received crossover vaccination). Statistical analysis was to proceed as survival analysis (time-to-event/time-to-infection) of cohort follow-up data during this period. There were no laboratory-confirmed cases of Ebola among study participants, so therefore no efficacy analyses were performed.
Number of Participants with Occurrence of SAEs within the 6-month follow-up period following a single dose of rVSVΔG-ZEBOV. Vaccination in the immediate group occurred within 7 days of enrollment if possible, and vaccination in the deferred-vaccination group occurred 18-24 weeks after enrollment.
| Arm | Type | Description |
|---|---|---|
| rVSVΔG-ZEBOV (immediate vaccination) | EXPERIMENTAL | One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10\^7 plaque forming units) |
| rVSVΔG-ZEBOV (deferred vaccination) | EXPERIMENTAL | One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10\^7 plaque forming units) in participants randomized to receive deferred vaccination (18-24 weeks after enrollment). |
| Name | Type | Description |
|---|---|---|
| rVSVΔG-ZEBOV | BIOLOGICAL | The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain). |
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 adm...