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Groups of 3 or 7 volunteers will be exposed to a predetermined number of male Schistosoma mansoni cercariae until 10 volunteers are found infected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Volunteers will be exposed to escalating doses of male Schistosoma mansoni cercariae |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| male Schistosoma mansoni cercariae | Biological | Viable male Schistosoma mansoni cercariae of the Puerto Rican strain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of grade 3 and 4 adverse events, possibly, probably or definitely related to controlled human Schistosoma mansoni infection with male cercariae. | 20 weeks | |
| The number of male cercariae at which 100% volunteers show detectable Schistosoma mansoni circulating anodic antigen (CAA). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Average number of weeks until positive serum circulating anodic antigen test | 12 weeks | |
| Comparison of the height of the peak serum circulating anodic antigen concentration in low dose compared with high dose group | 12 weeks |
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Inclusion Criteria:
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:
The chronic use of any drug known to interact with praziquantel, or artesunate or lumefantrine metabolism (e.g. phenytoin, carbamazepine, phenobarbital, primidon, dexamethasone, rifampicin, cimetidine, flecainide, metoprolol, imipramine, amitriptyline, clomipramine, class I 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 are excluded from the study.
For female subjects: positive urine pregnancy test at screening.
Any history of schistosomiasis or treatment for schistosomiasis.
Positive serology for schistosomiasis or elevated serum or urine circulating anodic antigen or positive Schistosoma serology at baseline.
Known hypersensitivity to or contra-indications (including co-medication) for use of praziquantel or, artesunate or lumefantrine.
Being an employee or student of the department of parasitology or infectious diseases of the Leiden University Medical Center.
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| Name | Affiliation | Role |
|---|---|---|
| Meta Roestenberg | LUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Leiden | 2333 ZA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30615787 | Result | Langenberg MCC, Hoogerwerf MA, Janse JJ, van Lieshout L, Corstjens PLAM, Roestenberg M; CoHSI clinical trial team. Katayama Syndrome Without Schistosoma mansoni Eggs. Ann Intern Med. 2019 May 21;170(10):732-733. doi: 10.7326/L18-0438. Epub 2019 Jan 8. No abstract available. | |
| 32066978 | Result | Langenberg MCC, Hoogerwerf MA, Koopman JPR, Janse JJ, Kos-van Oosterhoud J, Feijt C, Jochems SP, de Dood CJ, van Schuijlenburg R, Ozir-Fazalalikhan A, Manurung MD, Sartono E, van der Beek MT, Winkel BMF, Verbeek-Menken PH, Stam KA, van Leeuwen FWB, Meij P, van Diepen A, van Lieshout L, van Dam GJ, Corstjens PLAM, Hokke CH, Yazdanbakhsh M, Visser LG, Roestenberg M. A controlled human Schistosoma mansoni infection model to advance novel drugs, vaccines and diagnostics. Nat Med. 2020 Mar;26(3):326-332. doi: 10.1038/s41591-020-0759-x. Epub 2020 Feb 17. |
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| ID | Term |
|---|---|
| D012552 | Schistosomiasis |
| ID | Term |
|---|---|
| D014201 | Trematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| Comparison of the humoral (antibody) response profile by protein and glycan array between infected and uninfected individuals | 1 year |
| Differences in in ex vivo lymphocyte profiles between infected and uninfected individuals | 1 year |
| D000079426 |
| Vector Borne Diseases |