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

Tuberculosis (TB) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730795
• Other study ID #: 692342/001
• Secondary ID: CCTB001-01
• Status: Completed
• Phase: Phase 1
• First received: August 7, 2008
• Last updated: August 7, 2008
• Start date: January 2004

Study information

• Verified date: August 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. primary completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis (TB)

Intervention

Biological:
• GSK's candidate Mycobacterium tuberculosis vaccine 692342
Intramuscular injection, 3 doses at 0, 1, 2 months Different antigen doses (low and high)

Locations

Country	Name	City	State
United States	GSK Clinical Trials Call Center	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Corixa Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of dose limiting toxicity		From study start up to Day 56.
Primary	Occurrence of serious adverse events		During the entire study period.
Primary	Occurrence of adverse events		At each visit
Primary	Laboratory measurements of serum chemistry and hematology		At study start, prior to each vaccination and 1 and 6 months after dose 3
Primary	Resting vital signs (blood pressure, pulse, temperature)		At study start, prior to each vaccination and 1 and 6 months after dose 3
Primary	Chest X-ray findings		At study start and study end
Secondary	Evaluation of T cell and antibody responses to the fusion protein and to each of the three Mycobacterium tuberculosis antigen domains.		Prior to each vaccination and 1 and 6 months after dose 3
Secondary	Evaluation of PPD skin reactivity		At study start and study end