Malaria Plasmodium falciparum
Conditions
Interventions
All volunteers will be exposed to five P. falciparum NF135.C10 infected
mosquito-bites.
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 and
Exclusion criteria
Exclusion criteria: 1. History of malaria (other than participation in ZonMw1 study) or residence in malaria endemic areas within the past six months 2. Plans to travel to malaria endemic areas during the study period 3. Plans to travel outside of the Netherlands during the challenge period 4. Previous participation in any malaria vaccine study and/or positive serology for Pf (except ZonMw1 volunteers) 5. 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 6. History of diabetes mellitus or cancer (except basal cell carcinoma of the skin) 7. History of arrhythmias or prolonged QT-interval 8. Positive family history in 1st and 2nd degree relatives for cardiac events =5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system 10. Clinically significant abnormalities in electrocardiogram (ECG) at screening 11. Body Mass Index (BMI) below 18 or above 30 kg/m2 12. Any clinically significant deviation from the normal range in biochemistry or hematology blood tests or in urine analysis 13. Positive HIV, HBV or HCV tests 14. Participation in any other clinical study within 30 days prior to the onset of the study 15. Enrollment in any other clinical study during the study period 16. For women: being pregnant or lactating 17. Volunteers unable to give written informed consent 18. Volunteers unable to be closely followed for social, geographic or psychological reasons 19. History of drug or alcohol abuse interfering with normal social function 20. A history of treatment for psychiatric disease 21. A history of convulsions 22. Contra-indications to Malarone®, including hypersensitivity or treatment taken by the volunteer that interferes with Malarone® 23. The use of chronic immunosuppressive drugs, antibiotics, or other immune modifying drugs within three months of study onset (inhaled and topical corticosteroids and oral anti-histaminic are allowed) and during the study period 24. Any confirmed or suspected immunosuppressive or immunodeficient condition, including (functional) asplenia 25. Co-workers or trainees of the departments Infectious Diseases, Medical Microbiology or Parasitology of the Leiden University Medical Centre (LUMC) or Medical Microbiology, Parasitology, Radboud University Nijmegen (RUNMC) 26. A history of sickle cell anaemia, sickle cell trait, thalassaemia (or trait), G6PD deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: To determine protective immunity against a heterologous P. falciparum sporozoites re-challenge after previous CPS immunization and challenge. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: • Parasitemia and kinetics of parasitemia as measured by PCR • Frequency of signs or symptoms in study groups • Immune responses between study groups | — |
Countries
Netherlands
Outcome results
None listed