An interventional study of Exposure to 5 P. falciparum infected mosquitoes in P. Falciparum Malaria, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-11-09.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Basic science
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.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's planned enrollment of 15 is below the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion criteria
Previously protected volunteers, N=10
Biological: Exposure to 5 P. falciparum infected mosquitoes
5 malaria-naive volunteers
Biological: Exposure to 5 P. falciparum infected mosquitoes
Five Anopheles Stephensi mosquitoes are infected with NF54 P.falciparum. volunteers are exposed to bites for 10 minutes.
A significant difference in time of thick smear positivity between EHMI-8 and control volunteers
Time frame: 21 days
A significant quantitative difference in parasitemia as measured by PCR between EHMI-8 and control volunteers
Time frame: 21 days
A significant difference in kinetics of parasitemia between EHMI-8 and control volunteers as measured by PCR.
Time frame: 21 days
A difference in occurrence of signs or symptoms between EHMI-8 and control volunteers
Time frame: 21 days
Difference in immunological parameters between EHMI-8 and control volunteers.
Time frame: 140 days
This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center