drugset / Trial / NCT02240875
A Study to Assess New Ebola Vaccines, cAd3-EBO Z and MVA-BN® Filo
Phase 1
Completed
91 enrolled
University of Oxford
National Institute of Allergy and Infectious Diseases (NIAID) · collabWellcome Trust · collab
Non-randomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study is to assess two new Ebola vaccines: cAd3-EBO Z at 3 different doses, and a second vaccine, MVA-BN® Filo, at 3 different doses. The study will enable us to assess the safety of the vaccines and the extent of the immune response in healthy volunteers. The investigators will do this by giving volunteers a either one or two vaccinations, doing blood and saliva tests and collecting information about any symptoms that occur after vaccination. This is the first trial to use either of these vaccines in humans. We plan to recruit a total of 92 volunteers to be vaccinated.
Timeline
- Start
- 2014-09-17
- Primary completion
- 2017-08-22
- Completion
- 2017-08-22
Publications
- Lambe T, Rampling T, Samuel D, Bowyer G, Ewer KJ, Venkatraman N, Edmans M, Dicks S, Hill AV, Tedder RS, Gilbert SC. Detection of Vaccine-Induced Antibodies to Ebola Virus in Oral Fluid. Open Forum Infect Dis. 2016 Feb 22;3(1):ofw031. doi: 10.1093/ofid/ofw031. eCollection 2016 Jan.
- Ewer K, Rampling T, Venkatraman N, Bowyer G, Wright D, Lambe T, Imoukhuede EB, Payne R, Fehling SK, Strecker T, Biedenkopf N, Krahling V, Tully CM, Edwards NJ, Bentley EM, Samuel D, Labbe G, Jin J, Gibani M, Minhinnick A, Wilkie M, Poulton I, Lella N, Roberts R, Hartnell F, Bliss C, Sierra-Davidson K, Powlson J, Berrie E, Tedder R, Roman F, De Ryck I, Nicosia A, Sullivan NJ, Stanley DA, Mbaya OT, Ledgerwood JE, Schwartz RM, Siani L, Colloca S, Folgori A, Di Marco S, Cortese R, Wright E, Becker S, Graham BS, Koup RA, Levine MM, Volkmann A, Chaplin P, Pollard AJ, Draper SJ, Ballou WR, Lawrie A, Gilbert SC, Hill AV. A Monovalent Chimpanzee Adenovirus Ebola Vaccine Boosted with MVA. N Engl J Med. 2016 Apr 28;374(17):1635-46. doi: 10.1056/NEJMoa1411627. Epub 2015 Jan 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MVA-BN-Filo | Vaccine | 4.4e+07 unknown | — |
| Subject | MVA-BN-Filo | Vaccine | 2.2e+08 unknown | — |
| Subject | MVA-BN-Filo | Vaccine | 4.4e+08 unknown | — |
| Subject | cAd3-EBOZ | Vaccine | 1e+10 unknown | Intramuscular |
| Subject | cAd3-EBOZ | Vaccine | 2.5e+10 unknown | Intramuscular |
| Subject | cAd3-EBOZ | Vaccine | 5e+10 unknown | Intramuscular |