Experimental Infection of Hookworm-naïve Adults With Dermally-applied Infectious Necator Americanus Hookworm Larvae
Part of paid clinical trials in Washington D.C., District of Columbia.
- Sponsor
- Baylor College of Medicine
- Study ID
- NCT01940757
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Hookworm Infection
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 45 Years
- Healthy Volunteers
- Accepted
Interventions
- Necator americanus Hookworm Larvae — BIOLOGICALInfectious larvae of the human hookworm Necator americanus
Study Details
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.
Key Dates
- Start date
- Jan 31, 2015
- Status verified
- May 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 35 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- 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.
Primary Outcome Measure
Study product-related adverse events [ Time Frame: Up to 6 months after dosing ]
Central Contacts
- Study Coordinator(202) 994-1599
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| George Washington University Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | Aimee Desrosiers, PA (SUB_INVESTIGATOR) Elissa Malkin, DO, MPH (SUB_INVESTIGATOR) Caroline Thoreson, PA (SUB_INVESTIGATOR) |