An Experimental Infection Study of Dermally-applied Infectious Necator Americanus Hookworm Larvae in Hookworm-naïve Adults

Who is this study for? Hookworm-naïve adults
What treatments are being studied? Necator americanus Hookworm Larvae
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

An experimental hookworm infection model is being developed to provide early proof-of-concept that a hookworm vaccine targeting the blood-feeding pathway of adult hookworms is feasible and efficacious. The proposed model consists of vaccinating healthy, hookworm-naïve adults with a candidate hookworm vaccine, followed by challenging them with the investigational product, Necator americanus Larval Inoculum to assess the effect of vaccination on infection. The first proposed study will be a feasibility study that will consist of administering different doses of the Necator americanus Larval Inoculum to healthy adult volunteers to determine the optimal dose (i.e., number of infectious larvae) that is safe, well-tolerated and results in consistent infection.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• Males or females between 18 and 45 years, inclusive.

• Good general health as determined by means of the screening procedure.

• Available for the duration of the trial (6 months).

• Willingness to participate in the study as evidenced by signing the informed consent document.

Locations
United States
Washington, D.c.
George Washington University Medical Faculty Associates
RECRUITING
Washington D.c.
Contact Information
Primary
Study Coordinator
gwvru@gwu.edu
(202) 994-1599
Time Frame
Start Date: 2015-01
Estimated Completion Date: 2026-02
Participants
Target number of participants: 35
Treatments
Experimental: Cohort 1 (25 Necator americanus Hookworm Larvae)
A dose of 25 Necator americanus Hookworm Larvae, administered via a sterile absorbent pad fixed with a transparent adhesive dressing for at least 1 hour.
Experimental: Cohort 2 (50 Necator americanus Hookworm Larvae)
A dose of 50 Necator americanus Hookworm Larvae, administered via a sterile absorbent pad fixed with a transparent adhesive dressing for at least 1 hour.
Experimental: Cohort 3 (75 Necator americanus Hookworm Larvae)
A dose of 75 Necator americanus Hookworm Larvae, administered via a sterile absorbent pad fixed with a transparent adhesive dressing for at least 1 hour.
Sponsors
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov