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History of Changes for Study: NCT02755324
Single-sex Controlled Human Schistosomiasis Infection: Safety and Dose Finding
Latest version (submitted November 16, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 27, 2016 None (earliest Version on record)
2 November 24, 2016 Recruitment Status, Study Status and Contacts/Locations
3 January 30, 2017 Recruitment Status, Study Status and Study Design
4 June 29, 2017 Recruitment Status, Study Status, Oversight, Contacts/Locations and Sponsor/Collaborators
5 July 23, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
6 January 31, 2019 Recruitment Status and Study Status
7 November 16, 2020 References, Sponsor/Collaborators and Study Status
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Study NCT02755324
Submitted Date:  April 27, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: CoHSI1
Brief Title: Single-sex Controlled Human Schistosomiasis Infection: Safety and Dose Finding
Official Title: Establishing a Single-sex Controlled Human Schistosomiasis Infection Model: Safety and Dose Finding
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2016
Overall Status: Not yet recruiting
Study Start: July 2016
Primary Completion: March 2018 [Anticipated]
Study Completion: December 2018 [Anticipated]
First Submitted: April 25, 2016
First Submitted that
Met QC Criteria:
April 27, 2016
First Posted: April 28, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 27, 2016
Last Update Posted: April 28, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Leiden University Medical Center
Responsible Party: Principal Investigator
Investigator: MetaRoestenberg
Official Title: MD, PhD
Affiliation: Leiden University Medical Center
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: Groups of 3 or 7 volunteers will be exposed to a predetermined number of male Schistosoma mansoni cercariae until 10 volunteers are found infected.
Detailed Description:
Open or close this module Conditions
Conditions: Schistosomiasis
Schistosoma Mansoni
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Intervention
Volunteers will be exposed to escalating doses of male Schistosoma mansoni cercariae
Biological: male Schistosoma mansoni cercariae
Viable male Schistosoma mansoni cercariae of the Puerto Rican strain
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of grade 3 and 4 adverse events, possibly, probably or definitely related to controlled human Schistosoma mansoni infection with male cercariae.
[ Time Frame: 20 weeks ]

2. The number of male cercariae at which 100% volunteers show detectable Schistosoma mansoni circulating anodic antigen (CAA).
[ Time Frame: 12 weeks ]

Secondary Outcome Measures:
1. Average number of weeks until positive serum circulating anodic antigen test
[ Time Frame: 12 weeks ]

2. Comparison of the height of the peak serum circulating anodic antigen concentration in low dose compared with high dose group
[ Time Frame: 12 weeks ]

3. Comparison of the humoral (antibody) response profile by protein and glycan array between infected and uninfected individuals
[ Time Frame: 1 year ]

4. Differences in in ex vivo lymphocyte profiles between infected and uninfected individuals
[ Time Frame: 1 year ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 45 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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 and is reachable by mobile telephone from week 3 to week 12 of the study period.
  5. Subject agrees to refrain from blood donation 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, 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 HIV, hepatitis B or hepatitis C 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.
    • Any clinically significant abnormalities (including extended QT interval) on electrocardiogram
  2. The chronic use of any drug known to interact with praziquantel, or artesunate or lumefantrine metabolism (e.g. phenytoin, carbamazepine, phenobarbital, primidon, dexamethasone, rifampicin, cimetidine, flecainide, metoprolol, imipramine, amitriptyline, clomipramine, class I 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.
  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 or urine circulating anodic antigen or positive Schistosoma serology at baseline.
  6. Known hypersensitivity to or contra-indications (including co-medication) for use of praziquantel or, artesunate or lumefantrine.
  7. Being an employee or student of the department of parasitology or infectious diseases of the Leiden University Medical Center.
Open or close this module Contacts/Locations
Central Contact Person: Meta Roestenberg, MD.
Email: m.roestenberg@lumc.nl
Study Officials: Meta Roestenberg
Principal Investigator
LUMC
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Links:
Available IPD/Information:

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