CompletedNot Applicable

Repeated Controlled Human Schistosoma Mansoni Infection

Netherlands24 participantsStarted 2021-10-29

Plain-language summary

A group of 24 healthy volunteers are challenged one or three times with 20 male Schistosoma mansoni cercariae to investigate whether this leads to protection and to identify potential correlates of protection

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.
✓. Subject agrees to refrain from blood and plasma donation to Sanquin 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, (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:
✕. 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.
✕. 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 LUMC.

What they're measuring

Protective efficacy

Timeframe: From week 18 until week 30

Safety of (repeated) exposure to male Sm cercariae based on self-reported adverse events

Timeframe: 38 weeks

Trial details

NCT IDNCT05085470

SponsorLeiden University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-11

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