Hookworm infection parasitic infection
Conditions
Interventions
Twenty-four volunteers are randomized in a 2:1 ration to the intervention group
or placebo-group.
Immunization phase: In the intervention group, volunteers will receive three
infections with 50 L3
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 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 * 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 and 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 agrees to refrain from travel to a hookworm endemic area during the course of the trial. 7. Subject has signed informed consent.
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
| Measure | Time frame |
|---|---|
| Primary endpoints * Comparison of average egg counts of week 12 to 16 in the challenge phase by Kato Katz between intervention group and placebo group | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints * Adverse events collected during immunization phase and after controlled human hookworm infection. * Humoral (antibody) and cellular immunological changes after immunization and after controlled human hookworm infection. | — |
Countries
Netherlands
Outcome results
None listed