Maintaining Controlled Human Hookworm Infection Model studies at Leiden University Medical Centre
- Conditions
- hookworm
- Registration Number
- NL-OMON24634
- Lead Sponsor
- MC (Prof. M. Yazdanbakhsh)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 4
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 is male.
3. Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby.
4. Subject is able to communicate well with the investigator and is available to attend all study visits.
5. Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period.
6. Subject agrees to refrain from travel to a hookworm endemic area during the course of the trial.
7. Subject has signed informed consent.
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: ferritin <10ug/L, transferrin <2.04g/L or Hb <7.5 mmol/L.
- 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;
- inflammatory bowel syndrome;
- regular constipation, resulting in bowel movements less than three times per week.
2. Known hypersensitivity to or contra-indications for use of albendazole, including co-medication known to interact with albendazole metabolism (e.g. carbamazepine, phenobarbital, phenytoin, cimetidine, theophylline, dexamethasone).
3. Known allergy to amphotericin B or gentamicin.
4. Positive faecal qPCR for hookworm at screening, any known history of hookworm infection or treatment for hookworm infection.
5. Being an employee or student of the department of Parasitology of the LUMC.
6. Current or past scars, tattoos, or other disruptions of skin integrity at the intended site of larval application.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary objectives: <br>- To establish two hookworm-infected donors to set up the controlled human hookworm infection model in Gabon <br>- To study early-phase immune responses to hookworm exposure during the first four weeks after challenge
- Secondary Outcome Measures
Name Time Method Exploratory objectives: <br>- To describe the number of adverse events following single exposure to hookworm larvae<br>