malaria Plasmodium falciparum
Conditions
Interventions
Twenty four healthy volunteers will be randomised double-blindly to six groups
each consisting of 4 volunteers. Group 1 will be exposed to the bites of five
mosquitoes infected with the NF135.C10 st
Group 2
will be exposed to two NF135.C10-infected mosquitoes and 3 uninfected
mosquitoes
Group 3 will be exposed to one NF135.C10-infected mosquito and four
uninfected mosquitoes
Group 4 will be exposed to five NF166.C8-infected
mosquitoes
Group 5 will be exposed to two NF166.C8-infected mosquitoes and 3
uninfected mosquitoes
Group 6 will be exposed to one NF166.C8-infected
mosquito and four uninfected mosquitoes. Following exposure, all volunteers who
live >10km from the Havenziekenhuis will be required to stay in a stu
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is aged >= 18 and 10km) is willing to stay in a hotel close to the trial centre during part of the study (day 5 post-infection until three days post-treatment). Furthermore the subject will remain within the Netherlands during the study period and is reachable (24/7) by mobile telephone throughout the entire study period. 4. Subject agrees to inform his/her general practitioner about participation in the study and to sign a request to release by the GP any relevant medical information concerning possible contra-indications for participation in the study. 5. Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period and for a defined period thereafter according to current Sanquin guidelines. 6. For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study. 7. Subject has signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, infectious, immunodeficient, psychiatric and other disorders, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results. These include, but are not limited to, any of the following: 1.1 Body weight 30.0 kg/m2 at screening 1.2 A heightened risk of cardiovascular disease, defined as: an estimated ten year risk of fatal cardiovascular disease of >=5% at screening, as determined by the Systematic Coronary Risk Evaluation (SCORE); history, or evidence at screening, of clinically significant arrhythmia*s, prolonged QT-interval or other clinically relevant ECG abnormalities; or a positive family history of cardiac events in 1st or 2nd degree relatives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects developing patent parasitaemia after CHMI | — |
Secondary
| Measure | Time frame |
|---|---|
| Kinetics of parasitaemia in subjects after CHMI, e.g. pre-patent period and height of first peak, as assessed by qPCR Frequency and severity of adverse events | — |
Countries
Netherlands
Outcome results
None listed