Single-sex Female Controlled Human Schistosomiasis Mansoni Infection
Netherlands13 participantsStarted 2020-08-12
Plain-language summary
Groups of 3 or 7 volunteers will be exposed to a predetermined number of female Schistosoma mansoni cercariae until 10 volunteers are found infected.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria:
* Subject is aged ≥ 18 and ≤ 45 years and in good health.
* Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby.
* Subject is able to communicate well with the investigator, is available to attend all study visits.
* Subject will remain within Europe (excluding Corsica) during the study period and is reachable by mobile telephone from week 3 to week 8 of the study period.
* Subject agrees to refrain from blood donation to "Sanquin" (blood bank) or for other purposes throughout the study period.
* For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study.
* Subject has signed informed consent.
Exclusion Criteria:
* 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, 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 \>30.0 kg/m2 at screening;
* positive human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) screening tests;
* the use of immu…
What they're measuring
1
Number and severity of adverse events, possibly, probably or definitely related to controlled human Schistosoma mansoni infection with female cercariae.
Timeframe: 20 weeks
2
Number of female cercariae at which 100% volunteers show detectable Schistosoma mansoni circulating anodic antigen.