NL-OMON40942
Completed
Not Applicable
Controlled Human Malaria Infection after bites from mosquitoes infected with NF135.C10 or NF166.C8 Plasmodium falciparum parasites - BMGF2a
niversitair Medisch Centrum Sint Radboud0 sites24 target enrollmentStarted: TBDLast updated:
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- niversitair Medisch Centrum Sint Radboud
- Enrollment
- 24
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1\. Subject is aged \>\= 18 and \<\= 35 years and in good health.
- •2\. Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby.
- •3\. Subject is able to communicate well with the investigator, is available to attend all study visits and lives in proximity to the trial centre (\<10 km) or (if \>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
- •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 \<50 kg or Body Mass Index (BMI) \<18\.0 or \>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 \<50 years old.
- •1\.3 Functional asplenia, sickle cell trait/disease, thalassaemia trait/disease or G6PD deficiency.
- •1\.4 History of epilepsy in the period of five years prior to study onset, even if no longer on medication.
- •1\.5 Positive HIV, HBV or HCV screening tests.
- •1\.6 Chronic use of i) immunosuppressive drugs, ii) antibiotics, iii) or other immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti\-histamines exempted) or expected use of such during the study period.
- •1\.7 History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years
- •1\.8 Any history of treatment for severe psychiatric disease by a psychiatrist in the past year.
- •1\.9 History of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset, or positive urine toxicology test for cocaine or amphetamines at screening or prior to infection.
Investigators
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