Falciparum Malaria Clinical Trial
Official title:
Exposure of Human Volunteers to Live Malaria Sporozoites Under Chloroquine Prophylaxis
The objective of the study is to induce a protective immune response against malaria in healthy human volunteers. The different parts of the immune response will then be studied.
Efforts to develop vaccines against malaria still represent a substantial focus of current
research activities. Factors that have hampered the development of a subunit vaccine include
the complexity of the malaria life cycle, the wide variety of immune response induced by the
malaria parasite, and an incomplete knowledge of protective immunity. This study is
therefore aimed at inducing protective immunity against malaria in 15 healthy volunteers.
Volunteers will be exposed to the bites of infectious mosquitoes 3 times with live P.
falciparum sporozoites under chloroquine prophylaxis. Challenge with infected mosquitoes
will be given after stopping chloroquine prophylaxis.
Five volunteers will form a control group; they will be exposed to non-infectious mosquitoes
under chloroquine prophylaxis.
Endpoints include the time and height of parasitemia after challenge, the development of
fever and immunological parameters.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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