Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473967
Status:
TERMINATED
Last Update Posted:
2012-07-09
First Post:
2007-05-14
Brief Title:
Phase 1 Trial of Na-ASP-2 Hookworm Vaccine in Previously Infected Brazilian Adults
Sponsor:
Albert B Sabin Vaccine Institute
Organization:
Albert B Sabin Vaccine Institute
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 n36 or Butang hepatitis B vaccine n12
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 n36 or Butang hepatitis B vaccine n12
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:
None
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?:
None