NCT03257072

Repeated Controlled Human Hookworm Infection

Repeated Controlled Human Hookworm Infection in Healthy Dutch Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Meta Roestenberg · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Twenty-four healthy hookworm-naive volunteers will be exposed to 50 L3 Necator americanus larvae for a maximum of three times.

Detailed description

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 with 50 L3 Necator americanus larvae. Group A will receive infection at week 4 only. Group B will be infected at week 2 and week 4. Group C will be infected at week 0, 2 and 4. To maintain blinding, group A and B will receive mock infections with water at week 0 and week 0 and 2 respectively. The interval between each CHHI is 2 weeks. Before every infection, the safety will be assessed by a review of adverse events data with a local safety monitor. Sixteen weeks after the last infection (week 20), all volunteers will be offered treatment with a 3-day regimen of albendazole to abrogate infection. Volunteers with average egg counts \>250 eggs per gram will be asked if they would be willing to keep their infection for a maximum of two years (chronic donors). No more than four volunteers will be selected to be chronic donors. Six months after the last infection (or after the last donation for the chronic donors) volunteers will undergo their last visit.

Conditions

• Necator Americanus Infection

Interventions

Type	Name	Description
BIOLOGICAL	50 Necator americanus L3 larvae	1x50 Necator americanus L3 larvae
BIOLOGICAL	100 Necator americanus L3 larvae	2x50 Necator americanus L3 larvae
BIOLOGICAL	150 Necator americanus L3 larvae	3x50 Necator americanus L3 larvae

Timeline

• Start date: 2018-01-10
• Primary completion: 2018-08-30
• Completion: 2018-08-30
• First posted: 2017-08-22
• Last updated: 2020-11-18

Locations

1 site across 1 country: Netherlands