This study will assess the superior protective immunity of the combination of chloroquine and azithromycin prophylaxis under Chemoprophylaxis Sporozoites (CPS) immunization versus a standard chloroquine prophylactic regimen.
This study assesses the superiority of protective immunity of the combination of chloroquine and azithromycin prophylaxis under Chemoprophylaxis Sporozoites (CPS) immunization versus a standard chloroquine prophylactic regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Azithromycin capsules will be administered at each immunization
Placebo capsules will be administered at each immunization
three inoculations with 5 infected mosquito bites
Leiden University Medical Centre
Leiden, Leiden, Netherlands
Volunteers falciparum positive by thick smear
Percentage of P. falciparum thick smear negative volunteers on day 21 (protection against challenge infection)
Time frame: One year
Duration of pre-patent period by thick smear
Duration of pre-patent period after challenge infection as measured by microscopy (thick smear)
Time frame: One year
Kinetics of parasitemia by PCR
Development of parasitemia as measured by PCR
Time frame: One year
Adverse events
Frequency of adverse events in study groups
Time frame: One year
Immune responses
Immune responses between study groups
Time frame: One year
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