Clinical Trial: Establishing a Controlled Human Hookworm Infection Model at Leiden University Medical Center

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Establishing a Controlled Human Hookworm Infection Model at Leiden University Medical Center

Brief Summary: Four healthy hookworm-naive volunteers will be exposed to 50 L3 Necator americanus larvae once and will retain infection for up to 2 years.

Detailed Summary:

Four volunteers will be exposed to 50 Necator americanus L3 larvae. Volunteers will be followed on a weekly basis until week 12 after infection. If volunteers develop a patent infection, defined by detectable egg production in stool by microscopy at any timepoint within week 9 to 12, they will be scheduled to donate faeces on request.

Two years after infection or if volunteers do not excrete eggs detectable by microscopy on week 9 to 12, volunteers will be treated with a 3-day regimen of albendazole to abrogate the infection. Retreatment with albendazole will be given to volunteers who remain positive for hookworm after treatment.

Six months after the treatment, volunteers will undergo their last visit.


Sponsor: Leiden University Medical Center

Current Primary Outcome: Detection of hookworm eggs by faeces microscopy (Kato-Katz) at any week between week 9 to 12 post-infection. [ Time Frame: 12 weeks ]

Detection of hookworm eggs by faeces microscopy (Kato-Katz) at any week between week 9 to 12 post-infection.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of adverse events following single exposure to hookworm larvae [ Time Frame: 2 years ]
    Number of adverse events following single exposure to hookworm larvae
  • Humoral (antibody) and cellular immunological changes after controlled human hookworm infection [ Time Frame: 2 years ]
    Humoral (antibody) and cellular immunological changes after controlled human hookworm infection
  • Time to positive faeces test for hookworm as defined by Kato-Katz and qPCR [ Time Frame: 12 weeks ]
    Time to positive faeces test for hookworm as defined by Kato-Katz and qPCR


Original Secondary Outcome: Same as current

Information By: Leiden University Medical Center

Dates:
Date Received: March 29, 2017
Date Started: April 1, 2017
Date Completion: April 2019
Last Updated: April 19, 2017
Last Verified: April 2017