CompletedNot Applicable

Establishing a Controlled Human Hookworm Infection Model at Leiden University Medical Center

Netherlands4 participantsStarted 2017-04-01

Plain-language summary

Four healthy hookworm-naive volunteers will be exposed to 50 L3 Necator americanus larvae once and will retain infection for up to 2 years.

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.
✓. 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.
✓. Subjects are able to respond to phone or email within 24 hours during the first 12 weeks of the study.
✓. 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:

Detection of hookworm eggs by faeces microscopy (Kato-Katz) at any week between week 9 to 12 post-infection.

Timeframe: 12 weeks

NCT IDNCT03126552

SponsorLeiden University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-08-15

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.
✓. 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.
✓. Subjects are able to respond to phone or email within 24 hours during the first 12 weeks of the study.
✓. 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: