A Clinical Trial to Assess the Safety and Immunogenicity of New Malaria Vaccine Candidates ChAd63 Pfs25-IMX313 and MVA Pfs25-IMX313
NCT02532049 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2017-07-17
Summary
This is a clinical trial in which healthy volunteers will be administered one or two experimental malaria vaccines. ChAd Pfs-IMX313 will either be administered alone or with MVA Pfs25-IMX313 in a prime-boost regime.
All vaccines will be administered intramuscularly.
Group 1 will receive one dose of ChAd63 Pfs25-IMX313 at 5x10\^9 vp.
Group 2A will receive one dose of ChAd63 Pfs-IMX313 at 5x10\^10 vp.
Group 2B will receive one dose of ChAd63 Pfs-IMX313 at 5x10\^10 vp and one dose of MVA Pfs25-IMX313 at 1x10\^8 pfu eight weeks later.
Group 2C will receive one dose of ChAd63 Pfs25-IMX313 at 5x10\^10 vp and one dose of MVA Pfs25-IMX313 at 2x10\^8 pfu eight weeks later.
The study will assess the safety of the vaccinations, and the immune responses to the vaccination. Immune responses are measured by tests on blood samples.
Healthy volunteers will be recruited in Oxford and Southampton, England.
Conditions
Interventions
- BIOLOGICAL
-
ChAd63 Pfs25-IMX313
- BIOLOGICAL
-
MVA Pfs25-IMX313
Sponsors & Collaborators
-
University of Oxford
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-10-12
- Primary Completion
- 2017-05-25
- Completion
- 2017-05-25
Countries
- United Kingdom
Study Locations
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