Repeated Controlled Human Hookworm Infection — ReCHHI1  

Necator Americanus Infection Clinical Trial

Official title: Repeated Controlled Human Hookworm Infection in Healthy Dutch Volunteers

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Communicable Diseases
• Hookworm Infections
• Infection
• Necator Americanus Infection

• NCT number: NCT03257072
• Study type: Interventional
• Source: Leiden University Medical Center
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Completion date: August 30, 2018