Exposure of human volunteers to live malaria sporozoites under chloroquine prophylaxis
- Conditions
- malaria10019815
- Registration Number
- NL-OMON30242
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
Healthy 18-45 y/o
Exclusion Criteria
Systemic disorders
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints (parasitological):<br /><br>1. A significant difference in time of thick smear positivity between exposed<br /><br>and control groups<br /><br>2. A significant difference in parasitemia as measured by 18S Pf NASBA between<br /><br>exposed and control group<br /><br>3. A significant difference in kinetics of parasitemia between exposed and<br /><br>control groups as measured by 18S Pf NASBA.<br /><br>4. A difference in occurrence or height of fever between exposed and control<br /><br>groups.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints (immunological):<br /><br>1. Significant differences in immune response between exposed and control<br /><br>volunteers<br /><br>2. Significant differences in the outcome of in vitro functional malaria assays<br /><br>between exposed and control volunteers<br /><br>3. Significant differences in cellular reactivity against Pf antigens<br /><br>4. Significant differences in parasite VAR gene expression during infection<br /><br>5. The identification of immune mechanisms that correlate with protection<br /><br>6. The identification of potential vaccine candidates that correlate with<br /><br>protection<br /><br>Exploratory endpoints (pathophysiological):<br /><br>1. To identify early changes in iron metabolism<br /><br>2. To identify early plasma changes in endothelial activation markers<br /><br>3. To identify early changes in flow-mediated vasodilatation (FMD)</p><br>