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

Clinical Trials Registration ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

[1]  S. Schrag,et al.  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 , 2018, The Journal of infectious diseases.

[2]  L. Rossen,et al.  Trends in Risk of Pregnancy Loss Among US Women, 1990-2011. , 2018, Paediatric and perinatal epidemiology.

[3]  Pierre-Stéphane Gsell,et al.  Ring vaccination with rVSV-ZEBOV under expanded access in response to an outbreak of Ebola virus disease in Guinea, 2016: an operational and vaccine safety report , 2017, The Lancet. Infectious diseases.

[4]  T. Monath,et al.  Phase 2 Placebo‐Controlled Trial of Two Vaccines to Prevent Ebola in Liberia , 2017, The New England journal of medicine.

[5]  M. Kieny,et al.  Safety and immunogenicity of rVSVΔG-ZEBOV-GP Ebola vaccine in adults and children in Lambaréné, Gabon: A phase I randomised trial , 2017, PLoS medicine.

[6]  R. Das,et al.  Six-Month Safety Data of Recombinant Vesicular Stomatitis Virus–Zaire Ebola Virus Envelope Glycoprotein Vaccine in a Phase 3 Double-Blind, Placebo-Controlled Randomized Study in Healthy Adults , 2017, The Journal of infectious diseases.

[7]  John-Arne Røttingen,et al.  Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola Ça Suffit!) , 2017, The Lancet.

[8]  W. J. Ramsey,et al.  A Recombinant Vesicular Stomatitis Virus Ebola Vaccine , 2017, The New England journal of medicine.

[9]  Robert Pinner,et al.  Implementing an Ebola Vaccine Study - Sierra Leone. , 2016, MMWR supplements.

[10]  M. Altfeld,et al.  Phase 1 Trials of rVSV Ebola Vaccine in Africa and Europe. , 2016, The New England journal of medicine.

[11]  A. Gulland.  Ebola vaccine will be made available for emergency use , 2016, BMJ : British Medical Journal.

[12]  T. Nyenswah,et al.  Implementation of an Ebola virus disease vaccine clinical trial during the Ebola epidemic in Liberia: Design, procedures, and challenges , 2016, Clinical trials.

[13]  A. Fauci,et al.  Conducting clinical trials in outbreak settings: Points to consider , 2016, Clinical trials.

[14]  Anne M Johnson,et al.  Role of healthcare workers in early epidemic spread of Ebola: policy implications of prophylactic compared to reactive vaccination policy in outbreak prevention and control , 2015, BMC Medicine.

[15]  S. Yerly,et al.  The effect of dose on the safety and immunogenicity of the VSV Ebola candidate vaccine: a randomised double-blind, placebo-controlled phase 1/2 trial. , 2015, The Lancet. Infectious diseases.

[16]  R. Price,et al.  Artemether-lumefantrine treatment of uncomplicated Plasmodium falciparum malaria: a systematic review and meta-analysis of day 7 lumefantrine concentrations and therapeutic response using individual patient data , 2015, BMC Medicine.

[17]  John-Arne Røttingen,et al.  Efficacy and effectiveness of an rVSV-vectored vaccine expressing Ebola surface glycoprotein: interim results from the Guinea ring vaccination cluster-randomised trial , 2015, The Lancet.

[18]  John-Arne Røttingen,et al.  The ring vaccination trial: a novel cluster randomised controlled trial design to evaluate vaccine efficacy and effectiveness during outbreaks, with special reference to Ebola , 2015, BMJ : British Medical Journal.

[19]  N. Turner.  Meeting of the Strategic Advisory Group of Experts on immunization, October 2014 – conclusions and recommendations. , 2015, Releve epidemiologique hebdomadaire.

[20]  J. Bresee,et al.  Ebola Virus Disease in Health Care Workers — Sierra Leone, 2014 , 2014, MMWR. Morbidity and mortality weekly report.

[21]  Cdc Covid- Response Team.  Update: Ebola Virus Disease Outbreak — West Africa, October 2014 , 2014, MMWR. Morbidity and mortality weekly report.

[22]  Lawrence O. Gostin,et al.  The Ebola epidemic: a global health emergency. , 2014, JAMA.

[23]  Judith A. Cohen,et al.  Investigator’s brochure , 2014 .

[24]  Wenle Zhao,et al.  Quantitative comparison of randomization designs in sequential clinical trials based on treatment balance and allocation randomness , 2012, Pharmaceutical statistics.

[25]  H. Feldmann,et al.  Recombinant vesicular stomatitis virus-based vaccines against Ebola and Marburg virus infections. , 2011, The Journal of infectious diseases.

[26]  H. Feldmann,et al.  Properties of Replication-Competent Vesicular Stomatitis Virus Vectors Expressing Glycoproteins of Filoviruses and Arenaviruses , 2004, Journal of Virology.

[27]  C. F. Wu,et al.  Some Restricted randomization rules in sequential designs , 1983 .