Malaria Clinical Trial
Official title:
Phase 1 and Phase 2a Clinical Trial:Immunization of Human Volunteers With P. Vivax Irradiated Sporozoites
It is possible to safely protect human volunteers immunized with P. vivax irradiated sporozoites from P. vivax challenge with live sporozoites.
Title: Phase 1 and Phase 2a Clinical Trial: Immunization of human volunteers with P. vivax
irr-spz. (Short name: Irrad-SPZ) Population 27 healthy adult volunteers, males and
non-pregnant females, between 18-45 years of age, who fulfill inclusion/exclusion criteria
(described below) as determined by clinical history and serological tests. Approximately 20
parasitized blood-donor volunteers will be required to infected Anopheles mosquitoes which
will be used to immunize volunteers with a total of 1000-1500 infected mosquitoes, during
8-10 months. Afterwards challenge to prove protection.
Number of Sites: 2 Study Duration: 2 years. Subject Duration : Step1: 1-2 hours to blood
donors; Step 2 and 3: 2 years to immunized volunteers Objectives Primary
• To assess the safety and protective efficacy of P. vivax irradiated sporozoite vaccination.
Secondary
- To determine the immune responses and duration elicited by the P. vivax challenge in
human Fy(+) volunteers previously immunized with irr-spz, as compared with non-immunized
human volunteers.
- To determine the immune responses and duration elicited by irr-spz immunization scheme
in human Fy(+) volunteers; comparing it with the same immunization scheme with non
irr-spz in Fy(-) participants, and also with controls exposed to the same mosquito bite
scheme as that of immunization but using mosquitoes without parasite infection.
- To study new antigens potentially useful to induce pre-erythrocytic protection against
P. vivax malaria infection
;
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