Clinical Trial: Phase 1 Trial of Na-ASP-2 Hookworm Vaccine in Previously Infected Brazilian Adults
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Double-blind, Randomized, Controlled Phase 1 Study of the Safety and Immunogenicity of Na-ASP-2 Hookworm Vaccine in Previously-Infected Brazilian Adults
Brief 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 Summary:
- 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.
Sponsor: Albert B. Sabin Vaccine Institute
Current Primary Outcome: To determine the frequency of vaccine-related adverse events, graded by severity, for each dose of the Na-ASP-2 Hookworm Vaccine [ Time Frame: For the duration of the study ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To determine the dose of Na-ASP-2 that generates the highest antibody response as determined by an indirect enzyme-linked immunosorbent assay (ELISA) [ Time Frame: 2 weeks after the third injection ]
- To assess and compare the duration of antibody response to Na-ASP-2 [ Time Frame: For the duration of the study ]
- To perform exploratory studies of the cellular immune responses to the Na-ASP-2 antigen both before and after immunization [ Time Frame: For the duration of the study ]
Original Secondary Outcome: Same as current
Information By: Albert B. Sabin Vaccine Institute
Dates:
Date Received: May 14, 2007
Date Started: May 2007
Date Completion:
Last Updated: July 6, 2012
Last Verified: July 2012