CompletedNot Applicable

Immunisation, Treatment and Controlled Human Hookworm Infection

Netherlands23 participantsStarted 2018-12-17

Plain-language summary

24 healthy volunteers will be immunized with three times 50 L3 larvae or placebo followed by treatment with albendazol and subsequently challenged with twice 50 L3 larvae.

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 and is available to attend all study visits.
✓. Subject agrees to refrain from blood donation to Sanquin 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 agrees to refrain from travel to a hookworm endemic area during the course of the trial.
✓. 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:
✕. 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).
✕. 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 department of Parasitology of the LUMC.
✕. Current or past scars, tattoos, or other disruptions of skin integrity at the intended site of larval application.

What they're measuring

Difference between egg counts between intervention and placebo group

Timeframe: week 25-29

Trial details

NCT IDNCT03702530

SponsorLeiden University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09-02

View on ClinicalTrials.gov More Necator Americanus Infection trials