This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63 CS, simian adenovirus encoding Plasmodium falciparum liver stage antigen, Circumsporozoite protein. All volunteers recruited will be healthy adults. They will be primed with various doses of AdCh63 CS administered intramuscularly. Some of the volunteers will receive a booster vaccination with MVA CS administered via intramuscular route. Safety data will be collected for each vaccination regimen. Secondary aim of this study will be to assess the immune responses generated by vaccination.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
24
ChAd63 CS 5x10\^9 vp intra-muscularly Day 0
ChAd63 CS 5x10\^9 vp intra-muscularly Day 0; MVA CS 2x10\^8 pfu intra-muscularly Day 56
ChAd63 CS 5x10\^10 vp intra-muscularly Day 0
ChAd63 CS 5x10\^10 vp intra-muscularly Day 0; MVA CS 2x10\^8 pfu intra-muscularly Day 56
Clinical Research Centre Royal College of Surgeons in Ireland (RCSI), Beaumont Hospital
Dublin, Ireland
Safety assessment of new candidate malaria vaccines ChAd63 CS
To assess the safety of new candidate malaria vaccines ChAd63 CS administered alone and with MVA CS in a prime-boost regime to healthy volunteers by recording local and systemic solicited and unsolicited adverse events.
Time frame: Participants will be followed for the duration of the study, an expected average of 12 months
Assessment of immune response induced by vaccination
To assess the humoral and cellular immune responses generated by ChAd63 CS when administered to healthy volunteers alone and with MVA CS by assessing induced antibody and T cell response to the vaccine insert.
Time frame: Participants will be followed for the duration of the study, an expected average of 12 months
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