Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine Given to PPD-Negative Adults

This study has been completed.
Sponsor:
Collaborator:
Corixa Corporation
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00730795
First received: August 7, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

This Phase I study will evaluate the safety and immunogenicity of two doses GSK Biologicals' candidate TB vaccine (692342) according to a 0, 1, 2 months schedule in PPD-negative adults.


Condition Intervention Phase
Tuberculosis (TB)
Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase I Open Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the Recombinant Mycobacterium Tuberculosis Vaccine, Mtb72F With AS02A Adjuvant, When Administered Intramuscularly to Healthy PPD-Negative Adults

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of dose limiting toxicity [ Time Frame: From study start up to Day 56. ]
  • Occurrence of serious adverse events [ Time Frame: During the entire study period. ]
  • Occurrence of adverse events [ Time Frame: At each visit ]
  • Laboratory measurements of serum chemistry and hematology [ Time Frame: At study start, prior to each vaccination and 1 and 6 months after dose 3 ]
  • Resting vital signs (blood pressure, pulse, temperature) [ Time Frame: At study start, prior to each vaccination and 1 and 6 months after dose 3 ]
  • Chest X-ray findings [ Time Frame: At study start and study end ]

Secondary Outcome Measures:
  • Evaluation of T cell and antibody responses to the fusion protein and to each of the three Mycobacterium tuberculosis antigen domains. [ Time Frame: Prior to each vaccination and 1 and 6 months after dose 3 ]
  • Evaluation of PPD skin reactivity [ Time Frame: At study start and study end ]

Enrollment: 12
Study Start Date: January 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects receiving the low-dose antigen candidate TB vaccine
Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342
Intramuscular injection, 3 doses at 0, 1, 2 months Different antigen doses (low and high)
Experimental: Group B
Subjects receiving the high-dose antigen candidate TB vaccine
Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342
Intramuscular injection, 3 doses at 0, 1, 2 months Different antigen doses (low and high)

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female between 18 and 40 years of age at the time of screening
  • Negative PPD skin test at screening.
  • Subjects must have chest X-ray showing no evidence of pulmonary pathology.
  • Female subjects of childbearing potential must have a negative serum pregnancy test at screening, must not be breast-feeding and are required to use adequate contraception from enrolment till 1 month after dose 3.
  • Screening laboratory values must be within the laboratory normal ranges.
  • Negative for human immunodeficiency virus-1 and 2 (HIV 1/2) antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.
  • Subjects must give written informed consent.
  • Subjects must be willing to make all evaluation visits, be readily reachable by telephone or personal contact by the study site personnel and have a permanent address.
  • Subjects' resting seated vital signs must be within the protocol-defined ranges.

Exclusion Criteria:

  • History of prior Bacillus Calmette-Guérin (BCG) vaccinations.
  • History of documented exposure to Mycobacterium tuberculosis.
  • History of previous administration of experimental Mycobacterium tuberculosis vaccines or previous exposure to experimental products containing components of the experimental vaccine.
  • History of employment in a healthcare facility in a capacity that had direct or indirect contact with TB patients.
  • Administration of any immunoglobulins or any immunotherapy within the 3 months preceding the first dose of study vaccination, and/or any blood products within the 4 months preceding HIV screening, or planned administrations during the study period.
  • Use of St. John's Wort within six months of the Day 0 visit or planned administrations during the study period.
  • Participation in another experimental protocol and/or receipt of any investigational products within 30 days prior to Day 0.
  • History of autoimmune disease or causes of immunosuppressive states.
  • 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.
  • History of significant psychiatric illness.
  • Current drug or alcohol abuse
  • History of previous anaphylaxis or severe allergic reaction to vaccines or any other allergen.
  • Subjects who are, in the opinion of the investigator, at significantly increased risk of non-cooperation with requirements of the study protocol.
  • Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements (including mineral preparations such as calcium carbonate), herbal medications except St. John's Wort, birth control pills, anti-histamines for seasonal allergies, SSRIs (e.g. Prozac, Zoloft, Paxil), NSAIDs (e.g. aspirin, ibuprofen), and acetominophen.
  • Chronic administration (defined as more than 14 days total) of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose.
  • History of chronic or intermittently recurring illnesses such as migraine headaches, diabetes, heart disease, and asthma.
  • Current administration of anti-TB prophylaxis or therapy.
  • History of administration of a live attenuated virus vaccine within 30 days of enrollment.
  • History of administration of a subunit or killed vaccine within 14 days of enrollment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730795

Locations
United States, Washington
GSK Clinical Trials Call Center
Tacoma, Washington, United States, 9843
Sponsors and Collaborators
GlaxoSmithKline
Corixa Corporation
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Isabelle Harpigny, GSK Biologicals
ClinicalTrials.gov Identifier: NCT00730795     History of Changes
Other Study ID Numbers: 692342/001, CCTB001-01
Study First Received: August 7, 2008
Last Updated: August 7, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Tuberculosis vaccine

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

ClinicalTrials.gov processed this record on April 17, 2014