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Maintaining Controlled Human Hookworm Infection Model studies at Leiden University Medical Center

Maintaining Controlled Human Hookworm Infection Model studies at Leiden University Medical Center - CHHIL2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55129
Enrollment
4
Registered
2021-03-12
Start date
2021-08-30
Completion date
Unknown
Last updated
2025-12-08

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 participants will be exposed to 50 Necator americanus (Na) larvae at week 0. Weekly follow up site visits will take place until week 4 after infection. Afterwards weekly follow up phone calls,

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Subject is aged >= 18 and

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 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: • 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 week 12 and 13 post-infection. • Humoral and cellular immunological changes in the first month after exposure to hookworm

Secondary

MeasureTime frame
• Number of adverse events following exposure to hookworm larvae

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)