Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT00473967
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 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:
NCT00473967
Study Brief:
Protocol Section:
NCT00473967