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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
26
CCVTM, University of Oxford, Churchill Hospital
Oxford, United Kingdom
NIHR Wellcome Trust Clinical Research Facility
Southampton, United Kingdom
Number of Adverse Events
The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.
Time frame: 8 months
Immunogenicity of ChAd63 Pfs25-IMX313 when administered to healthy volunteers alone, and with MVA Pfs25-IMX313 in a prime-boost regime.
Time frame: 8 months
Ex-vivo efficacy of ChAd63 Pfs25-IMX313 when administered to healthy volunteers alone, and with MVA Pfs25-IMX313 in a prime-boost regime. The functional activity of the vaccine induced antibodies will be tested using membrane-feeding assays.
Time frame: 8 months
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