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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.
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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.
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9 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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