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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections

ClinicalTrials.gov processed this record on November 23, 2014