NCT00473967

Phase 1 Trial of Na-ASP-2 Hookworm Vaccine in Previously Infected Brazilian Adults

Double-blind, Randomized, Controlled Phase 1 Study of the Safety and Immunogenicity of Na-ASP-2 Hookworm Vaccine in Previously-Infected Brazilian Adults

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Albert B. Sabin Vaccine Institute · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Na-ASP-2 is a protein expressed during the larval stage of the N. americanus hookworm life cycle. Vaccination with recombinant ASP-2 has protected dogs and hamsters from infection in challenge studies. In a clinical study in hookworm-uninfected adults in the USA, Na-ASP-2 Hookworm Vaccine was safe and immunogenic. This study will evaluate its safety and immunogenicity in individuals living in an area of endemic hookworm infection.

Detailed description

* Double-blind, randomized, controlled Phase 1 clinical trial. * Study site: Americaninhas, Minas Gerais, Brazil. * Number of participants: 48 in three groups of 16, randomized to receive either Na-ASP-2 Hookworm Vaccine (n=36) or Butang® hepatitis B vaccine (n=12). * Study duration: 48 weeks; each participant will be followed for a total of 42 weeks. * Immunization schedule: Study days 0, 56 and 112. * Route: IM in the deltoid muscle. * Dose of Na-ASP-2: 10, 50 and 100 µg for the first, second and third dose cohort, respectively. * Dose of Alhydrogel®: 800 µg for each dose of Na-ASP-2.

Conditions

• Hookworm Infection

Interventions

Type	Name	Description
BIOLOGICAL	Na-ASP-2 Hookworm Vaccine	Injections of one of three different dose concentrations of the Na-ASP-2 vaccine (10, 50, or 100 mcg) vs. the hepatitis B vaccine, delivered at 0, 2, and 4 months by intramuscular injection.

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-03-01
• Completion: 2009-03-01
• First posted: 2007-05-16
• Last updated: 2012-07-09

Locations

1 site across 1 country: Brazil