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.
* 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
9
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.
Centro de Pesquisas Rene Rachou
Belo Horizonte, Brazil
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
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
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