NCT03702530

Immunisation, Treatment and Controlled Human Hookworm Infection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Necator Americanus Infection

Interventions

Type	Name	Description
BIOLOGICAL	3x 50 L3 larvae immunisation with albendazole treatment	Immunisation with 50 Necator americanus L3 larvae at week 0, 3 and 6 with albendazole treatment at week 2, 5 and 8
OTHER	3x placebo immunisation with albendazole treatment	Mock immunisation with water at week 0, 3 and 6 with albendazole treatment at week 2, 5 and 8
BIOLOGICAL	2x 50 L3 larvae infection	After (mock) immunisation, infection with 50 Necator americanus larvae at week 13 and 15

Timeline

• Start date: 2018-12-17
• Primary completion: 2019-09-02
• Completion: 2019-09-02
• First posted: 2018-10-11
• Last updated: 2019-09-04

Locations

1 site across 1 country: Netherlands