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About
It is possible to safely protect human volunteers immunized with P. vivax irradiated sporozoites from P. vivax challenge with live sporozoites.
Full description
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
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Inclusion criteria
• Healthy 18 to 45 years old man or non-pregnant women.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
27 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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