Implementing a Multisite Clinical Trial in the Midst of an Ebola Outbreak: Lessons Learned From the Sierra Leone Trial to Introduce a Vaccine Against Ebola
| Autor: | Marc E Fischer, Wendi McDonald, Stephanie J. Schrag, Foday Sahr, Laura Gibson, Concepcion F. Estivariz, Anne Schuchat, Sara Hersey, Roselyn M’baindu Momoh, Joseph S. Bresee, Wendy Carr, Dayo Spencer-Walters, Stacie M. Greby, Jennifer Legardy-Williams, Ahamed Flagbata Kallon, Amanda C. Cohn, Jane F. Seward, Ayesha Idriss, Rosalind J Carter, Winston Webber, Joseph Edem-Hotah, Melvina Thompson, Mohamed Samai, Marc-Alain Widdowson, Julianne Gee, Stephen C. Hadler, Amy Callis |
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| Rok vydání: | 2018 |
| Předmět: |
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Drug-Related Side Effects and Adverse Reactions 030231 tropical medicine Supplement Articles Disease Outbreaks Sierra Leone Sierra leone 03 medical and health sciences Clinical Trials Phase II as Topic 0302 clinical medicine Political science Health care medicine Humans Immunology and Allergy 030212 general & internal medicine Ebola Vaccines Cold chain Randomized Controlled Trials as Topic Vaccines Synthetic Government business.industry Hotline Outbreak Hemorrhagic Fever Ebola medicine.disease Vaccination Clinical trial Infectious Diseases Clinical Trials Phase III as Topic Female Medical emergency business |
| Zdroj: | The Journal of Infectious Diseases. 217:S16-S23 |
| ISSN: | 1537-6613 0022-1899 |
| Popis: | The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE), a phase 2/3 trial of investigational rVSV∆G-ZEBOV-GP vaccine, was conducted during an unprecedented Ebola epidemic. More than 8600 eligible healthcare and frontline response workers were individually randomized to immediate (within 7 days) or deferred (within 18–24 weeks) vaccination and followed for 6 months after vaccination for serious adverse events and Ebola virus infection. Key challenges included limited infrastructure to support trial activities, unreliable electricity, and staff with limited clinical trial experience. Study staff made substantial infrastructure investments, including renovation of enrollment sites, laboratories, and government cold chain facilities, and imported equipment to store and transport vaccine at ≤−60oC. STRIVE built capacity by providing didactic and practical research training to >350 staff, which was reinforced with daily review and feedback meetings. The operational challenges of safety follow-up were addressed by issuing mobile telephones to participants, making home visits, and establishing a nurse triage hotline. Before the Ebola outbreak, Sierra Leone had limited infrastructure and staff to conduct clinical trials. Without interfering with the outbreak response, STRIVE responded to an urgent need and helped build this capacity. Clinical Trials Registration. ClinicalTrials.gov [{"type":"clinical-trial","attrs":{"text":"NCT02378753","term_id":"NCT02378753"}}NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220]. |
| Databáze: | OpenAIRE |
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