Immunisation, Treatment and Controlled Human Hookworm Infection - ITCHHI

eids Universitair Medisch Centrum0 sites23 target enrollmentTBD

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: eids Universitair Medisch Centrum
Enrollment: 23
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

September 2, 2019

Last Updated

2 years ago

Study Type

Interventional

Investigators

Sponsor

eids Universitair Medisch Centrum

Eligibility Criteria

Inclusion Criteria

•In order to be eligible to participate in this study, a subject must meet all of the following 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 and is available to attend all study visits.
•4\. Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period.
•5\. For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study.
•6\. Subject agrees to refrain from travel to a hookworm endemic area during the course of the trial.
•7\. Subject has signed informed consent.

Exclusion Criteria

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•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:
•\* positive HIV, HBV or 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;
•\* having one of the following laboratory abnormalities: ferritine \<10ug/L, transferrine \<2\.04g/L or Hb \<6\.5 mmol/L for females or \<7\.5 mmol/L for males.
•\* 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;
•\* inflammmatory bowel syndrome;
•\* regular constipation, resulting in bowel movements less than three times per week.