Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146744
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2005-09-06
Brief Title:
Safety and Immunogenicity of GSK Biologicals Candidate Tuberculosis Vaccine Mtb72FAS02A in Healthy PPD-positive Adults
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Double-blind Observer-blind Randomised Controlled Phase III Study to Evaluate the Safety Reactogenicity and Immunogenicity of GSK Biologicals Candidate Tuberculosis Vaccine Mtb72FAS02A Administered Intramuscularly at 0 1 2 Months to Healthy PPD-positive Volunteers Aged 18 to 50 Years
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the safety reactogenicity and immunogenicity of Mtb72FAS02A in healthy European volunteers who are PPD-positive either via previous vaccination with BCG andor conversion to PPD positivity through exposure to Mycobacterium tuberculosis
Detailed Description:
The BCG vaccine has been widely available for several decades It is easy and cheap to produce and when given to neonates or young children it is effective in preventing severe manifestations of disease such as meningeal tuberculosis and miliary tuberculosis However in terms of the capacity of the vaccine to protect adult humans it shows a wide range of efficacy including zero levels of protection Due to the general realization that BCG is losing its protective effect particularly in terms of preventing adult-onset tuberculosis a major effort has been made to try to develop new alternative vaccines One such candidate Mtb72FAS02A is a polyprotein derived from two known M tuberculosis antigens adjuvanted with AS02A Mtb72FAS02A is a candidate TB vaccine under development for two indications prevention of primary TB infection in young children in highly endemic areas and as an adjunct to treatment for TB in adolescents and adults
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