Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Groups of 3 or 7 volunteers will be exposed to a predetermined number of female Schistosoma mansoni cercariae until 10 volunteers are found infected.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Volunteers will be exposed to escalating doses of female Schistosoma mansoni cercariae |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| female Schistosoma mansoni cercariae | Biological | Viable female Schistosoma mansoni cercariae of the Puerto Rican strain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of adverse events, possibly, probably or definitely related to controlled human Schistosoma mansoni infection with female cercariae. | 20 weeks | |
| Number of female cercariae at which 100% volunteers show detectable Schistosoma mansoni circulating anodic antigen. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Average number of weeks until positive serum circulating anodic antigen (CAA) test | 8 weeks | |
| Comparison of peak serum circulating anodic antigen (CAA) concentration in different dose groups | 8 weeks |
Not provided
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:
For female subjects: positive urine pregnancy test at screening.
Any history of schistosomiasis or treatment for schistosomiasis.
Positive serology for schistosomiasis or elevated serum CAA at screening.
Known hypersensitivity to or contra-indications (including co-medication) for use of praziquantel, artesunate or lumefantrine.
Being an employee or student of the department of parasitology or infectious diseases of the Leiden University Medical Center.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Leiden | 2333 ZA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37837930 | Background | Koopman JPR, Houlder EL, Janse JJ, Casacuberta-Partal M, Lamers OAC, Sijtsma JC, de Dood C, Hilt ST, Ozir-Fazalalikhan A, Kuiper VP, Roozen GVT, de Bes-Roeleveld LM, Kruize YCM, Wammes LJ, Smits HH, van Lieshout L, van Dam GJ, van Amerongen-Westra IM, Meij P, Corstjens PLAM, Jochems SP, van Diepen A, Yazdanbakhsh M, Hokke CH, Roestenberg M. Safety and infectivity of female cercariae in Schistosoma-naive, healthy participants: a controlled human Schistosoma mansoni infection study. EBioMedicine. 2023 Nov;97:104832. doi: 10.1016/j.ebiom.2023.104832. Epub 2023 Oct 12. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012552 | Schistosomiasis |
| D012555 | Schistosomiasis mansoni |
| ID | Term |
|---|---|
| D014201 | Trematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Humoral (antibody) response profile by protein and glycan array between infected and uninfected individuals | 1 year |
| Ex vivo lymphocyte profiles using flow cytometry between infected and uninfected individuals | 1 year |
| Changes over time in commensal gut bacteria by looking at the relative abundance of microbiota using 16S rRNA gene amplicon sequencing after controlled human Schistosoma mansoni infection with female cercariae | 1 year |
| D000079426 |
| Vector Borne Diseases |