Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT00473967
Status:
TERMINATED
Last Update Posted:
2012-07-09
First Post:
2007-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 1 Trial of Na-ASP-2 Hookworm Vaccine in Previously Infected Brazilian Adults
Sponsor:
Albert B. Sabin Vaccine Institute
Organization:
Study Overview
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
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Occurrence of unacceptable adverse events.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: