A Safety and Efficacy Study of R21 +/- ChAd63/MVA ME-TRAP
NCT02905019 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 63
Last updated 2018-06-13
Summary
The purpose of this study is to assess the safety and efficacy of adjuvanted R21 alone and in combination with a viral-vectored vaccine regimen (constituting adjuvanted R21 + ChAd63 and MVA encoding ME-TRAP) against malaria sporozoite challenge in healthy malaria-naive volunteers.
Healthy adult volunteers will be recruited in London, Oxford and Southampton.
All vaccinations will be administered intramuscularly. The study involves having either two, three or five vaccinations and then undergoing challenge infection with malaria, or receiving no vaccinations then undergoing challenge infection with malaria.
Conditions
Interventions
- BIOLOGICAL
-
R21 with Matrix-M1
Vaccine
- BIOLOGICAL
-
ChAd63 ME-TRAP
Vaccine
- BIOLOGICAL
-
MVA ME-TRAP
Vaccine
Sponsors & Collaborators
-
University of Oxford
lead OTHER
Principal Investigators
-
Adrian V Hill, DPhil FRCP · Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hosptal, Oxford, United Kingdom
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-08-31
- Primary Completion
- 2017-12-21
- Completion
- 2017-12-21
Countries
- United Kingdom
Study Locations
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