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Safety and Immunogenicity of GSK Biological's Candidate Tuberculosis Vaccine Mtb72F/AS02A in Healthy PPD-positive Adults

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00146744
First received: September 6, 2005
Last updated: February 10, 2011
Last verified: February 2011
History of Changes
  Purpose

This study will evaluate the safety, reactogenicity and immunogenicity of Mtb72F/AS02A in healthy European volunteers who are PPD-positive either via previous vaccination with BCG and/or conversion to PPD positivity through exposure to Mycobacterium tuberculosis.


Condition Intervention Phase
Tuberculosis
 Biological: Mtb72F/AS02A
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Double-blind (Observer-blind), Randomised, Controlled, Phase I/II Study, to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Candidate Tuberculosis Vaccine, Mtb72F/AS02A Administered Intramuscularly at 0, 1, 2 Months to Healthy PPD-positive Volunteers Aged 18 to 50 Years

Resource links provided by NLM:

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity as assessed by humoral and CMI response. [ Designated as safety issue: No ]

Estimated Enrollment: 38
Study Start Date: July 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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, Mtb72F/AS02A, is a polyprotein derived from two known M. tuberculosis antigens adjuvanted with AS02A. Mtb72F/AS02A 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA

  • Written informed consent
  • Healthy PPD-positive volunteers aged 18 to 50 years
  • No active pulmonary disease as confirmed by chest X-ray
  • No history of extrapulmonary TB
  • 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00146744

Locations
Switzerland
GSK Investigational Site
Lausanne, Switzerland, 1011
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00146744     History of Changes
Other Study ID Numbers: 102374
Study First Received: September 6, 2005
Last Updated: February 10, 2011
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 21, 2013