NCT06478498

Immune Responses in the Skin After Hookworm Infection

Investigating the Local Immune Responses in the Skin After Repeated Hookworm Infection

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Five healthy volunteers will be repeatedly exposed to L3 Necator americanus larvae after which two skin biopsies will be taken. Three of the volunteers will be treated two weeks after each infection after which the study will end after 13 weeks. Two of the volunteers will retain the infection for up to two years and will be asked to donate stool samples.

Detailed description

Five volunteers will be exposed to 50 Necator americanus L3 larvae, after which they will be treated with a curative regimen of albendazole after two weeks. Then, they will be inoculated with a lower dose of 10 L3 larvae concentrated on one spot, followed by two skin biopsies (one at the inoculation site, the other one serving as a negative control). Subsequently, participants will be treated with albendazole at week 5, except for the participants who have volunteered to become chronic donors. For chronic donors, patency of infection will be assessed and infections repeated (max dose 50 L3 larvae at one time) until egg outputs are \>1500 eggs per gram (epg) at the start of the donor phase. If necessary, top-up inoculations can be performed in the donor phase as well when the egg-output is too low for the requested experiments.

Conditions

• Necator Americanus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Necator americanus L3 larvae	Necator americanus L3 larvae

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-01-01
• Completion: 2026-10-01
• First posted: 2024-06-27
• Last updated: 2024-07-12

Locations

1 site across 1 country: Netherlands