Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Single-sex Controlled Human Schistosomiasis Infection: Safety and Dose Finding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02755324
Recruitment Status : Completed
First Posted : April 28, 2016
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Meta Roestenberg, Leiden University Medical Center

Tracking Information
First Submitted Date  ICMJE April 25, 2016
First Posted Date  ICMJE April 28, 2016
Last Update Posted Date February 1, 2019
Actual Study Start Date  ICMJE October 27, 2016
Actual Primary Completion Date July 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2016)
  • 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 ]
  • The number of male cercariae at which 100% volunteers show detectable Schistosoma mansoni circulating anodic antigen (CAA). [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02755324 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2016)
  • Average number of weeks until positive serum circulating anodic antigen test [ Time Frame: 12 weeks ]
  • Comparison of the height of the peak serum circulating anodic antigen concentration in low dose compared with high dose group [ Time Frame: 12 weeks ]
  • Comparison of the humoral (antibody) response profile by protein and glycan array between infected and uninfected individuals [ Time Frame: 1 year ]
  • Differences in in ex vivo lymphocyte profiles between infected and uninfected individuals [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single-sex Controlled Human Schistosomiasis Infection: Safety and Dose Finding
Official Title  ICMJE Establishing a Single-sex Controlled Human Schistosomiasis Infection Model: Safety and Dose Finding
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Schistosomiasis
  • Schistosoma Mansoni
Intervention  ICMJE Biological: male Schistosoma mansoni cercariae
Viable male Schistosoma mansoni cercariae of the Puerto Rican strain
Study Arms  ICMJE Experimental: Intervention
Volunteers will be exposed to escalating doses of male Schistosoma mansoni cercariae
Intervention: Biological: male Schistosoma mansoni cercariae
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2018)
17
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2016)
40
Actual Study Completion Date  ICMJE January 21, 2019
Actual Primary Completion Date July 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02755324
Other Study ID Numbers  ICMJE CoHSI1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Meta Roestenberg, Leiden University Medical Center
Study Sponsor  ICMJE Leiden University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Meta Roestenberg LUMC
PRS Account Leiden University Medical Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP