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

Hookworm Infection Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hookworm Infection
• Hookworm Infections

• NCT number: NCT00473967
• Study type: Interventional
• Source: Albert B. Sabin Vaccine Institute
• Status: Terminated
• Phase: Phase 1
• Start date: May 2007
• Completion date: March 2009