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Sponsored by: |
Radboud University |
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Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00757887 |
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.
Condition | Intervention |
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P. Falciparum Malaria |
Biological: Exposure to 5 P. falciparum infected mosquitoes |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Re-Exposure of EHMI-8 Human Volunteers to Live Malaria Sporozoites |
Estimated Enrollment: | 15 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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EHMI8: Experimental
Previously protected volunteers, N=10
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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.
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control: Active Comparator
5 malaria-naive volunteers
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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.
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Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Only for newly recruited control volunteers: previous participation in any malaria vaccine study and/or positive serology for P.
falciparum
Contact: Meta Roestenberg, MD | +31 24 3610577 | M.Roestenberg@aig.umcn.nl |
Netherlands | |
UMC St. Radboud | |
Nijmegen, Netherlands, 6500 HB |
Principal Investigator: | Robert Sauerwein, Prof. Dr. | Radboud University |
Responsible Party: | Radboud University ( Prof. Dr. R.W. Sauerwein ) |
Study ID Numbers: | EHMI-8B |
Study First Received: | September 22, 2008 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00757887 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
malaria plasmodium falciparum human experimental infection |
Protozoan Infections Parasitic Diseases Malaria Malaria, Falciparum |
Protozoan Infections Coccidiosis Parasitic Diseases Malaria Malaria, Falciparum |