Safety and Immunogenicity of GSK Biological’s Candidate Tuberculosis Vaccine Mtb72F/AS02 in Healthy PPD-Negative Adults. - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 14, 2006

Last Updated Date

February 6, 2007

Start Date ^†

July 2004

Current Primary Outcome Measures ^†

Occurrence of solicited symptoms during the 7-day follow-up period, unsolicited symptoms during the 30-day follow-up period, grade 3 vaccine related local and general symptoms during the 30-day follow-up and serious adverse events during the entire study

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00291889 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Immunogenicity as assessed by humoral and CMI response.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Safety and Immunogenicity of GSK Biological’s Candidate Tuberculosis Vaccine Mtb72F/AS02 in Healthy PPD-Negative Adults.

Official Title ^†

Evaluate the Safety, Reactogenicity & Immunogenicity of 2 Antigen Dose Levels of GSK Biologicals’ Candidate Tuberculosis Vaccine, Mtb72F/AS02 to Healthy PPD-Negative Volunteers Aged 18 to 45 Yrs

Brief Summary

Vaccination against tuberculosis (TB) /healthy PPD-negative adults aged 18 to 45 years.Three doses of primary vaccination followed by a booster dose after completion of primary vaccination course. Booster vaccination will be given only to subjects receiving the candidate tuberculosis vaccines and not to the subjects receiving active comparators or control.

Detailed Description

The safety and immunogenicity of 2 antigen doses in PPD-negative adults will be evaluated. In addition, 2 active comparator groups of volunteers will receive the vaccine alone without an immunostimulant and 1 control group will receive the adjuvant (AS02) alone to assess the true effect of the candidate tuberculosis vaccine (Mtb72F/AS02).

Study Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Condition ^†

Tuberculosis

Intervention ^†

Biological: Mtb72F/AS02.

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

INCLUSION CRITERIA:

Written informed consent
Healthy PPD-negative volunteers aged 18 to 45 years
No evidence of pulmonary pathology (i.e. acute or chronic pulmonary disease; past TB infection/disease) as confirmed by chest X-ray.
Seronegative for HIV 1 and 2, HBsAg, and HCV
Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, complete blood count (CBC) and differential, haemoglobin, platelet count and urinalysis.
Females : Non pregnant, must use adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

EXCLUSION CRITERIA:

Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
History of prior Bacillus Calmette-Guérin (BCG) vaccination.
History of documented exposure to Mycobacterium tuberculosis
History of prior vaccination with experimental Mycobacterium Tuberculosis vaccines or experimental products containing MPL or QS21.
Any confirmed or suspected immunosuppressive or immunodeficient condition; or family history of congenital or hereditary immunodeficiency.
History of hypersensitivity to vaccines or vaccine components
History of any acute or chronic illness or medication that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine"

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Belgium

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00291889

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

February 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.