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| Name | Class |
|---|---|
| Centre Hospitalier Universitaire Vaudois | OTHER |
| Radboud University Medical Center | OTHER |
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Phase I/IIa double-blind randomized (adjuvant)-controlled trial. 16 volunteers are randomized to receive two doses of either 30 µg of PfCS102 formulated in Montanide ISA 720 (verum) or ISA 720 alone (control), 60 days apart. Two weeks after the 2nd immunization, 14 volunteers are challenged with bites of 5 infected mosquitoes using the NF54 strain of P. falciparum. The main outcome will be the length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy performed twice a day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vaccine | Experimental | 30 µg of PfCS102 formulated in Montanide ISA 720 |
|
| adjuvant | Placebo Comparator | Montanide ISA 720 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PfCS102 | Biological | Antigen of the sporozoite protein |
| |
| Montanide ISA 720 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy | 1month |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Blaise Genton, MD PhD | University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ambulatory Care and Community Medicine; University Hospital | Lausanne | 1011 | Switzerland |
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| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C432063 | circumsporozoite protein (282-383), Plasmodium falciparum |
| C001681 | mannide monooleate |
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| Biological |
adjuvant alone |
|
| D000096724 |
| Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |