Brief Title
Single-sex Female Controlled Human Schistosomiasis Mansoni Infection
Official Title
Establishing a Female-only Controlled Human Schistosoma Mansoni Infection Model: a Safety and Dose Finding Study (CoHSI2)
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 Type
Interventional
Primary Outcome
Number and severity of adverse events, possibly, probably or definitely related to controlled human Schistosoma mansoni infection with female cercariae.
Secondary Outcome
Average number of weeks until positive serum circulating anodic antigen (CAA) test
Condition
Schistosomiasis
Intervention
female Schistosoma mansoni cercariae
Study Arms / Comparison Groups
Intervention
Description: Volunteers will be exposed to escalating doses of female Schistosoma mansoni cercariae
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
22
Start Date
August 12, 2020
Completion Date
June 2022
Primary Completion Date
June 2022
Eligibility Criteria
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.
Gender
All
Ages
18 Years - 45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
, +31715269111, [email protected]
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT04269915
Organization ID
CoHSI2
Responsible Party
Principal Investigator
Study Sponsor
Leiden University Medical Center
Study Sponsor
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Verification Date
September 2020