Phase I/IIa double-blind randomized (adjuvant)-controlled trial. 16 volunteers are randomized to receive two doses of either 30 µg of PfCS102 formulated in Montanide ISA 720 (verum) or ISA 720 alone (control), 60 days apart. Two weeks after the 2nd immunization, 14 volunteers are challenged with bites of 5 infected mosquitoes using the NF54 strain of P. falciparum. The main outcome will be the length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy performed twice a day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
16
Antigen of the sporozoite protein
adjuvant alone
Department of Ambulatory Care and Community Medicine; University Hospital
Lausanne, Switzerland
Length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy
Time frame: 1month
Incidence of adverse events
Time frame: 15 days
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