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Your search keyword '"Samai, Mohamed"' showing total 7 results
Start Over Author "Samai, Mohamed" Topic ebola virus disease vaccines
7 results on '"Samai, Mohamed"'

1. The Sierra Leone Trial to Introduce a Vaccine Against Ebola: An Evaluation of rVSV∆G-ZEBOV-GP Vaccine Tolerability and Safety During the West Africa Ebola Outbreak.

Author

Samai, Mohamed, Seward, Jane F., Goldstein, Susan T., Mahon, Barbara E., Radcliffe Lisk, Durodami, Widdowson, Marc-Alain, Jalloh, Mohamed I., Schrag, Stephanie J., Idriss, Ayesha, Carter, Rosalind J., Dawson, Peter, Kargbo, S. A. S., Leigh, Bailah, Bawoh, Mohamed, Legardy-Williams, Jennifer, Deen, Gibrilla, Carr, Wendy, Callis, Amy, Lindblad, Robert, and Russell, James B. W.

Subjects
*CLINICAL trials, *EBOLA virus disease, *VACCINE effectiveness, *EBOLA virus disease vaccines, *DISEASE outbreaks, *VESICULAR stomatitis, *PUBLIC health, *THERAPEUTICS
Abstract

Clinical Trials Registration: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220]. [ABSTRACT FROM AUTHOR]

Published
2018
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2. 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.

Author

Carter, Rosalind J., Idriss, Ayesha, Widdowson, Marc-Alain, Samai, Mohamed, Schrag, Stephanie J., Legardy-Williams, Jennifer K., Estivariz, Concepcion F., Callis, Amy, Carr, Wendy, Webber, Winston, Fischer, Marc E., Hadler, Stephen, Sahr, Foday, Thompson, Melvina, Greby, Stacie M., Edem-Hotah, Joseph, Momoh, Roselyn M'baindu, McDonald, Wendi, Gee, Julianne M., and Kallon, Ahamed Flagbata

Subjects
CLINICAL trials, EBOLA virus disease vaccines, VACCINES, DISEASE outbreaks, PUBLIC health
Abstract

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 [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220]. [ABSTRACT FROM AUTHOR]

Published
2018
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3. Lessons Learned in Clinical Trial Communication During an Ebola Outbreak: The Implementation of STRIVE.

Author

Callis, Amy, Carter, Victoria M., Ramakrishnan, Aparna, Albert, Alison P., Conteh, Lansana, Barrie, Alhaji Amadu, Fahnbulleh, Lucian, Koroma, Mark M., Saidu, Samuel, Williams, Otis, and Samai, Mohamed

Subjects
CLINICAL trials, EBOLA virus disease vaccines, MEDICAL communication, TRUST, COMMUNITY involvement, INFORMED consent (Medical law)
Abstract

Clinical Trials Registration: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220]. [ABSTRACT FROM AUTHOR]

Published
2018
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4. Operationalizing International Regulatory Standards in a Limited-Resource Setting During an Epidemic: The Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE) Experience.

Author

Kabineh, Abdul Karim, Carr, Wendy, Motevalli, Mahnaz, Legardy-Williams, Jennifer, Vincent, Willietta, Mahon, Barbara E., and Samai, Mohamed

Subjects
CLINICAL trials, VACCINES, EBOLA virus disease vaccines, MEDICAL research, STANDARD operating procedure, PUBLIC health, SAFETY
Abstract

Clinical Trials Registration: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220]. [ABSTRACT FROM AUTHOR]

Published
2018
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5. Participant Retention in a Randomized Clinical Trial in an Outbreak Setting: Lessons From the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE).

Author

Carter, Rosalind J., Senesi, Reynold G. B., Dawson, Peter, Gassama, Ibrahim, Kargbo, S. A. S., Petrie, Carey R., Rogers, Mohamed Hashim, Samai, Mohamed, and Luman, Elizabeth T.

Subjects
CLINICAL trials, VACCINES, EBOLA virus disease vaccines, VACCINE effectiveness, LOGISTIC regression analysis, PUBLIC health
Abstract

Clinical Trials Registration: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220]. [ABSTRACT FROM AUTHOR]

Published
2018
Full Text
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6. 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.

Author

Conteh, Muhammad-Abbas, Goldstein, Susan T., Wurie, Haja R., Gidudu, Jane, Radcliffe Lisk, Durodami, Carter, Rosalind J., Seward, Jane F., Hampton, Lee M., Wang, David, Andersen, Lauren E., Arvay, Melissa, Schrag, Stephanie J., Dawson, Peter, Fombah, Augustin E., Petrie, Carey R., Feikin, Daniel R., Russell, James B. W., Lindblad, Robert, Kargbo, S. A. S., and Samai, Mohamed

Subjects
CLINICAL trials, VACCINES, EBOLA virus disease vaccines, EPIDEMICS, PUBLIC health
Abstract

Clinical Trials Registration: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220]. [ABSTRACT FROM AUTHOR]

Published
2018
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7. Rapid Establishment of a Cold Chain Capacity of -60°C or Colder for the STRIVE Ebola Vaccine Trial During the Ebola Outbreak in Sierra Leone.

Author

Jusu, Morrison O., Glauser, Geoffrey, Seward, Jane F., Bawoh, Mohamed, Tempel, Judith, Friend, Michael, Littlefield, Daniel, Lahai, Michael, Jalloh, Hassan M., Sesay, Amara Bangali, Caulker, Amanda F., Samai, Mohamed, Thomas, Vasavi, Farrell, Nicholas, and Widdowson, Marc-Alain

Subjects
EBOLA virus disease vaccines, VIRAL vaccines, GLYCOPROTEINS, EBOLA virus disease, CLINICAL trials, PUBLIC health
Abstract

Clinical Trials Registration: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220]. [ABSTRACT FROM AUTHOR]

Published
2018
Full Text
View/download PDF

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