Ignite Creation Date:
2024-07-17 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478498
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-24
Brief Title:
Immune Responses in the Skin After Hookworm Infection
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Investigating the Local Immune Responses in the Skin After Repeated Hookworm Infection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HiBiSki
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None