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

NCT00730795 | Completed Phase 1

• 2 other identifiers: 692342/001CCTB001-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tuberculosis (TB)

Keywords

Tuberculosis vaccine

Outcome Measures

Primary Outcomes (6)

• Occurrence of dose limiting toxicity

  From study start up to Day 56.

• Occurrence of serious adverse events

  During the entire study period.

• Occurrence of adverse events

  At each visit

• Laboratory measurements of serum chemistry and hematology

  At study start, prior to each vaccination and 1 and 6 months after dose 3

• Resting vital signs (blood pressure, pulse, temperature)

  At study start, prior to each vaccination and 1 and 6 months after dose 3

• Chest X-ray findings

  At study start and study end

Secondary Outcomes (2)

• 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

• Evaluation of PPD skin reactivity

  At study start and study end

Study Arms (2)

Group A

EXPERIMENTAL

Subjects receiving the low-dose antigen candidate TB vaccine

Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342

Group B

EXPERIMENTAL

Subjects receiving the high-dose antigen candidate TB vaccine

Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342

Interventions

GSK's candidate Mycobacterium tuberculosis vaccine 692342 BIOLOGICAL

Intramuscular injection, 3 doses at 0, 1, 2 months Different antigen doses (low and high)

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Corixa Corporation: collaborator

Study Sites (1)

GSK Clinical Trials Call Center

Tacoma, Washington, 9843, United States

Location

Related Publications (1)

• Von Eschen K, Morrison R, Braun M, Ofori-Anyinam O, De Kock E, Pavithran P, Koutsoukos M, Moris P, Cain D, Dubois MC, Cohen J, Ballou WR. The candidate tuberculosis vaccine Mtb72F/AS02A: Tolerability and immunogenicity in humans. Hum Vaccin. 2009 Jul;5(7):475-82. doi: 10.4161/hv.8570. Epub 2009 Jul 27.

  PMID: 19587528 DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 8, 2008
• Study Start: January 1, 2004
• Primary Completion: December 1, 2004
• Last Updated: August 8, 2008

Record last verified: 2008-08

Locations

US (1)