24 healthy volunteers will be immunized with three times 50 L3 larvae or placebo followed by treatment with albendazol and subsequently challenged with twice 50 L3 larvae.
24 healthy hookworm-naive volunteers will be randomized in a 2:1 allocation to either the intervention group or placebo. Volunteers in the intervention group will be immunized three times with 50 L3 larvae of Necator americanus with three-week intervals. Two weeks after each immunization, volunteers will be treated with albendazole. Four weeks after the last treatment all volunteers are challenged with controlled human hookworm infection consisting of two doses of 50 L3 larvae with a two week interval. 16 weeks after the first challenge all volunteers will be treated with albendazole, except up to four volunteers who will be asked to remain as chronic donors for future hookworm studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
23
Immunisation with 50 Necator americanus L3 larvae at week 0, 3 and 6 with albendazole treatment at week 2, 5 and 8
Mock immunisation with water at week 0, 3 and 6 with albendazole treatment at week 2, 5 and 8
After (mock) immunisation, infection with 50 Necator americanus larvae at week 13 and 15
Leiden University Medical Center
Leiden, Netherlands
Difference between egg counts between intervention and placebo group
Comparison of average egg counts from week 25-29 of the trial (which is week 12 to 16 after controlled human hookworm infection) by Kato-Katz between intervention group and placebo group
Time frame: week 25-29
Frequency of adverse events
Comparison of frequency of adverse events collected during immunisation phase and after controlled human hookworm infection between intervention and placebo group
Time frame: week 0-29
Severity of adverse events
Comparison of severity of adverse events collected during immunisation phase and after controlled human hookworm infection between intervention and placebo group
Time frame: week 0-29
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