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

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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

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.
    



Study Type

Interventional


Primary Outcome

Number of grade 3 and 4 adverse events, possibly, probably or definitely related to controlled human Schistosoma mansoni infection with male cercariae.

Secondary Outcome

 Average number of weeks until positive serum circulating anodic antigen test

Condition

Schistosomiasis

Intervention

male Schistosoma mansoni cercariae

Study Arms / Comparison Groups

 Intervention
Description:  Volunteers will be exposed to escalating doses of male 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

17

Start Date

October 27, 2016

Completion Date

January 21, 2019

Primary Completion Date

July 19, 2018

Eligibility 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.
      

Gender

All

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Meta Roestenberg, , 

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT02755324

Organization ID

CoHSI1


Responsible Party

Principal Investigator

Study Sponsor

Leiden University Medical Center


Study Sponsor

Meta Roestenberg, Principal Investigator, LUMC


Verification Date

January 2019