Immune Responses in the Skin After Hookworm Infection (NCT06478498) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Immune Responses in the Skin After Hookworm Infection
Netherlands5 participantsStarted 2024-10-01
Plain-language summary
Five healthy volunteers will be repeatedly exposed to L3 Necator americanus larvae after which two skin biopsies will be taken. Three of the volunteers will be treated two weeks after each infection after which the study will end after 13 weeks. Two of the volunteers will retain the infection for up to two years and will be asked to donate stool samples.
Who can participate
Age range18 Years – 45 Years
SexALL
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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 agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period.
✓. Subject agrees to refrain from travel to a hookworm endemic area during the course of the trial.
✓. Subject has signed informed consent (note: there are different informed consent forms for group A- and B participants).
✓. Agrees to remain infected and to commit to study procedures and rules
✓. Agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period.
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:
✕. Known hypersensitivity to or contra-indications for use of albendazole, including comedication known to interact with albendazole metabolism (e.g. carbamazepine, phenobarbital, phenytoin, cimetidine, theophylline, dexamethasone).
What they're measuring
1
Identity of skin effector cells
Timeframe: 3 weeks + 1 day after initial infection (timepoint of taking the biopsies)
2
Correlation between macroscopic skin response and effector cells
Timeframe: 3 weeks + 1 day after initial infection (timepoint of taking the biopsies)
✕. Known allergy to amphotericin B or gentamicin.
✕. For female subjects: positive urine pregnancy test at screening
✕. Positive faecal qPCR for hookworm at screening, any known history of hookworm infection or treatment for hookworm infection.
✕. Being an employee or student of the study team.
✕. Current or past scars, tattoos, or other disruptions of skin integrity at the intended site of larval application.
✕. increased risk of complications after skin biopsy (e.g. use of anticoagulants, immunosuppressive medication or having tattoo's in the biopsy region).