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
- Conditions
- P. falciparum infection (malaria)
- Registration Number
- EUCTR2006-001743-66-NL
- Lead Sponsor
- INSTITUT PASTEUR, Biomedical Parasitology Unit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
-The use of chronic medication, especially immunosuppressive agents or antibiotics
-Known hypersensitivity to any of the vaccine components
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Main objective : To assess the safety and immunogenicity (phase I) of two formulations of the candidate vaccine LSA-3 in humans and to assess its protective efficacy in a sporozoite challenge (phase IIa).<br>;Secondary Objective: ;Primary end point(s): Safety and immunogenicity data<br>Evaluation of protective efficacy<br>
- Secondary Outcome Measures
Name Time Method