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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42940
Enrollment
4
Registered
2017-03-14
Start date
2017-05-04
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hookworm Necator americanus

Interventions

Four volunteers will be exposed to 50 Necator americanus L3 larvae. Volunteers will be followed on a weekly basis until week 12 after infection. If volunteers develop a patent infection, defined by

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. 1. Subject is aged * 18 and * 45 years. 2. Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby. 3. Subject is able to communicate well with the investigator, is available to attend all study visits. 4. Subjects are able to respond to phone or email within 24 hours during the first 12 weeks of the study. 5. Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period. 6. For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study. 7. Subject has signed informed consent.

Exclusion criteria

Exclusion criteria: 1. 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: * History of severe asthma or other health conditions that may require future steroid use; * body weight 30.0 kg/m2 at screening; * 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: ferritine

Design outcomes

Primary

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

Secondary

MeasureTime frame
None

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)