Single-sex Female Controlled Human Schistosomiasis Mansoni Infection

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 Status

Biological

Estimated Enrollment

22

Start Date

May 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

NCT ID

NCT04269915

Organization ID

CoHSI2

Responsible Party

Principal Investigator

Study Sponsor

Leiden University Medical Center

Study Sponsor

, , 

Verification Date

February 2020