NCT04269915CompletedNot Applicable
Establishing a Female-only Controlled Human Schistosoma Mansoni Infection Model: a Safety and Dose Finding Study (CoHSI2)
Leiden University Medical Center2 sites in 1 country13 target enrollmentStarted: August 12, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- Number and severity of adverse events, possibly, probably or definitely related to controlled human Schistosoma mansoni infection with female cercariae.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 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.
- •The chronic use of any drug known to interact with praziquantel, artesunate or lumefantrine metabolism (e.g. phenytoin, carbamazepine, phenobarbital, primidon, dexamethasone, rifampicin, cimetidine, flecainide, metoprolol, imipramine, amitriptyline, clomipramine, class I-A 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 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.
Outcomes
Primary Outcomes
Number and severity of adverse events, possibly, probably or definitely related to controlled human Schistosoma mansoni infection with female cercariae.
Time Frame: 20 weeks
Number of female cercariae at which 100% volunteers show detectable Schistosoma mansoni circulating anodic antigen.
Time Frame: 8 weeks
Secondary Outcomes
- Ex vivo lymphocyte profiles using flow cytometry between infected and uninfected individuals(1 year)
- Comparison of peak serum circulating anodic antigen (CAA) concentration in different dose groups(8 weeks)
- Humoral (antibody) response profile by protein and glycan array between infected and uninfected individuals(1 year)
- Average number of weeks until positive serum circulating anodic antigen (CAA) test(8 weeks)
- 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)
Investigators
Meta Roestenberg
Principal Investigator
Leiden University Medical Center
Study Sites (2)
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