CompletedNot Applicable

Repeated Controlled Human Hookworm Infection

Netherlands24 participantsStarted 2018-01-10

Plain-language summary

Twenty-four healthy hookworm-naive volunteers will be exposed to 50 L3 Necator americanus larvae for a maximum of three times.

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.

✓. 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.
✓. For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study.
✓. Subject has signed informed consent.

✕. 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 or Kato-Katz for hookworm at screening, any known history of hookworm infection or treatment for hookworm infection or possible exposure to hookworm in the past
✕. 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
✕. Subjects with planned travel to hookworm endemic areas during this trial

Frequency of adverse events

Timeframe: 28 weeks

Magnitude of adverse events

Timeframe: 28 weeks

NCT IDNCT03257072

SponsorMeta Roestenberg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-08-30

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.

✓. 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.
✓. For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study.
✓. Subject has signed informed consent.

✕. 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 or Kato-Katz for hookworm at screening, any known history of hookworm infection or treatment for hookworm infection or possible exposure to hookworm in the past
✕. 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
✕. Subjects with planned travel to hookworm endemic areas during this trial