P. falciparum infection (malaria)
Conditions
Interventions
Product Name: LSA3-rec
Product Code: LSA3-rec
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: not available
Current Sponsor code: LSA3-rec
Other descriptive name: LSA3-re
Sponsors
INSTITUT PASTEUR, Biomedical Parasitology Unit
Eligibility
Sex/Gender
All
Inclusion 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). ;Secondary Objective: ;Primary end point(s): Safety and immunogenicity data Evaluation of protective efficacy | — |
Countries
Netherlands
Outcome results
None listed