Safety and protective efficacy of repeated controlled human Schistosoma mansoni Infectio

Completed

• Conditions: bilharzia; Schistosomiasis; 10019381

• Registration Number: NL-OMON50894
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2024-01-02
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1. Subject is aged >= 18 and <= 45 years and in good health.
2. Subject has adequate understanding of the procedures of the study and agrees
to abide strictly thereby.
3. Subject is able to communicate well with the investigator, is available to
attend all study visits.
4. Subject will remain within Europe (excluding Corsica) during the study
period.
5. Subject agrees to refrain from blood and plasma donation to Sanquin or for
other purposes throughout the study period.
6. For female subjects: subject agrees to use adequate contraception and not to
breastfeed for the duration of study.
7. Subject has signed informed consent.

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, HBV or HCV 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. phenytoïn, carbamazepine, phenobarbital,
primidon, dexamethason, rifampicine, cimetidine, flecaïnide, metoprolol,
imipramine, amitriptyline, clomipramine, class IA and III anti-arrythmics,
antipsychotics, antidepressants, macrolides, fluorchinolones, 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- The protective efficacy of repeated exposure to male Sm cercariae measured by<br /><br>the difference in frequency of serum CAA positivity (>=1.0 pg/mL) between the<br /><br>reinfection group and the infection control group at any timepoint after the<br /><br>final infection at week 18;<br /><br>- Frequency and severity of adverse events after (repeated) human Sm infection<br /><br>with male cercariae</p><br>