Hookworm infection parasitic infection
Conditions
Interventions
Twenty-four volunteers will be allocated equally into three groups (i.e. group
A, B, C). Group A, B, and C will have one, two, and three infections
respectively. Every infection will be performed wi
Hookworm
Infectious disease
Tropical disease
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Subject is aged * 18 and * 45 years and in good health. 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. Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period. 5. For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study. 6. Subject has signed informed consent.
Exclusion criteria
Exclusion criteria: 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: * Body Mass Index (BMI) 35.0 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
| Measure | Time frame |
|---|---|
| Frequency and magnitude of adverse events as compared between study groups A, B and C. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints * Variability in egg secretion by Kato-Katz from week 16 to 20 * The lowest dose at which there is 100% patent hookworm infection, as defined by a positive Kato-Katz at any time between week 16 to 20 * Comparison of the average number of eggs secreted by Kato-Katz and qPCR between different groups in weeks 16-20 after the infection * Humoral (antibody) and cellular immunological changes after controlled human hookworm infection. Exploratory endpoints * Changes in metabolomic profile in urine, serum, and faeces after CHHI * Changes in gut microbiome after CHHI * Time to positive faeces test for hookworm as defined by Kato-Katz and qPCR * Changes in lactose/mannitol ratio and related biomarkers of intestinal permeability (i.e. serum zonulin, serum LPS) and intestinal inflammation (i.e. fecal calprotectin, serum diamine oxidase) after CHHI | — |
Countries
The Netherlands
Outcome results
None listed