EUCTR2006-001743-66-NL
Active, not recruiting
Not Applicable
Phase I and IIa trial to assess the safety, immunogenicity and protective efficacy against sporozoite challenge of the candidate malaria vaccine pfLSA-3 vaccine. - LSA3-trial
INSTITUT PASTEUR, Biomedical Parasitology Unit0 sitesOctober 20, 2006
ConditionsP. falciparum infection (malaria)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- P. falciparum infection (malaria)
- Sponsor
- INSTITUT PASTEUR, Biomedical Parasitology Unit
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Healthy male adults, aged 18 to 45 years
- •\- Available for a sporozoite challenge following the immunization course
- •\- Resident near the Radboud University Medical Center Nijmegen
- •\- Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •\- Any history of malaria
- •\-Planned to travel to endemic malaria areas during the study period
- •\-Prior administration of an investigational malaria vaccine
- •\-Participation in any other clinical trial within 90 days prior to the onset of the trial
- •\-Body Mass Index \<20kg/m2 or \> 32 kg/m2
- •\-Blood pressure \> 150/90 in two measurements
- •\-Symptoms, physical signs and laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the study results or compromise the health of the volunteers
- •\-Seropositive for HIV, HBV or HCV
- •\- An estimated, ten year risk of fatal cardiovascular disease of \=5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system.
- •\-Any clinically significant deviation from the normal range in biochemistry or haematology blood tests or in urine analysis
Outcomes
Primary Outcomes
Not specified
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