Repeated Controlled Human Schistosoma Mansoni Infection

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, immune-deficient, (severe) 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:
• •* body weight \<50 kg or Body Mass Index (BMI) \<18.0 or \>35.0 kg/m2 at screening;
• •* positive HIV, hepatitis B virus or hepatitis C virus screening tests;
• •* the use of 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;
• •* history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years;
• •* any history of treatment for severe psychiatric disease by a psychiatrist in the past year;
• •* history of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset.
• •2. The chronic use of any drug known to interact with praziquantel, artesunate or lumefantrine metabolism (e.g. phenytoin, carbamazepine, phenobarbital, primidone, dexamethasone, rifampicin, cimetidine, flecainide, metoprolol, imipramine, amitriptyline, clomipramine, class IA and III anti-arrythmics, antipsychotics, antidepressants, macrolides, fluoroquinolones, imidazole- and triazole antimycotics, antihistamines). Because lumefantrine may cause extension of QT-time, chronic use of drugs with effect on QT interval will result in exclusion from study participation.
• •3. For female subjects: positive urine pregnancy test at screening.
• •4. Any history of schistosomiasis or treatment for schistosomiasis.
• •5. Positive serology for schistosomiasis or elevated serum CAA at screening.
• •6. Known hypersensitivity to or contra-indications (including co-medication) for use of praziquantel, artesunate or lumefantrine.
• •7. Being an employee or student of the department of Parasitology or Infectious diseases of the LUMC.