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Re-exposure of EHMI-8 Human Volunteers to Live Malaria Sporozoites

Not Applicable
Completed
Conditions
P. Falciparum Malaria
Interventions
Biological: Exposure to 5 P. falciparum infected mosquitoes
Registration Number
NCT00757887
Lead Sponsor
Radboud University Medical Center
Brief Summary

In the EHMI-8 study (CMO 2006/207) the investigators induced sterile protection against P. falciparum challenge in healthy Dutch volunteers by repeated exposure to infected mosquitoes whilst under chloroquine prophylaxis. The surprisingly efficient induction of protection in this study strongly supports the development of whole parasite vaccines and is therefore an important finding to malaria vaccine development. In this study (EHMI8B) the investigators would like to explore the longevity of the protective immune response and simultaneously further characterise immune mechanisms responsible for protection by re-exposing EHMI-8 volunteers to infected mosquito bites.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
15
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
EHMI8Exposure to 5 P. falciparum infected mosquitoesPreviously protected volunteers, N=10
controlExposure to 5 P. falciparum infected mosquitoes5 malaria-naive volunteers
Primary Outcome Measures
NameTimeMethod
A difference in occurrence of signs or symptoms between EHMI-8 and control volunteers21 days
A significant difference in time of thick smear positivity between EHMI-8 and control volunteers21 days
A significant difference in kinetics of parasitemia between EHMI-8 and control volunteers as measured by PCR.21 days
A significant quantitative difference in parasitemia as measured by PCR between EHMI-8 and control volunteers21 days
Secondary Outcome Measures
NameTimeMethod
Difference in immunological parameters between EHMI-8 and control volunteers.140 days

Trial Locations

Locations (1)

UMC St. Radboud

🇳🇱

Nijmegen, Netherlands

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