Safety and Immunogenicity of GSK Biological's Candidate T... | NCT00291889

Studies
Safety and Immunogenicity of GSK Biological's Candidate Tuberculosis Vaccine Mtb72F/AS02 in Healthy PPD-negative Adults.

NCT00291889

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

May 30, 2017Actual

Enrollment

50Actual

Phase

Phase 1

Conditions

Tuberculosis (TB)

Interventions

Mtb72F/AS02.

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2004

Primary Completion Date

May 2005Actual

Completion Date

May 2005Actual

First Submitted Date

Feb 14, 2006

First Submission Date that Met QC Criteria

Feb 14, 2006

First Posted Date

Feb 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2017

Last Update Posted Date

May 30, 2017Actual

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Name	Type	Description	Arm Group Labels	Other Names
Mtb72F/AS02.	Biological

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Immunogenicity as assessed by humoral and CMI response.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections