Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Healthy HIV Negative Adolescents

This study has been completed.
Sponsor:
Collaborator:
Aeras
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00950612
First received: July 23, 2009
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

This observer blind study will assess the safety and immunogenicity of GSK Biologicals' investigational 692342 vaccine administered at 0, 1 month to healthy adolescents living in a TB-endemic region.


Condition Intervention Phase
Tuberculosis (TB)
Biological: GSK's investigational vaccine 692342
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccine (692342) When Administered to Healthy HIV-negative Adolescents Living in a TB Endemic Region

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of solicited local and general adverse events after each vaccination [ Time Frame: During the 7-day follow-up period ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events after each vaccination [ Time Frame: During the 30-day follow-up period ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: From screening up to study end (Day 210) ] [ Designated as safety issue: No ]
  • Haematological and biochemical levels [ Time Frame: Prior to vaccination (Day 0), post dose 1 (Day 7 and 30) and post dose 2 (Day 37 and 60) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cell-mediated immunogenicity with respect to components of the investigational vaccine [ Time Frame: Prior to vaccination (Day 0), post dose 1 (Day 7 and 30) and post dose 2 (Day 37, 60 and 210) ] [ Designated as safety issue: No ]
  • Humoral immunogenicity with respect to components of the investigational vaccine [ Time Frame: Prior to vaccination (Day 0), post dose 1 (Day 7 and 30) and post dose 2 (Day 37, 60 and 210) ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: December 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: GSK's investigational vaccine 692342
Intramuscular injection, 2 doses
Placebo Comparator: Group B Biological: Placebo
Intramuscular injection, 2 doses

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they and their parent(s)/ legal guardian(s) can and will comply with the requirements of the protocol.
  • A male or female between, and including, 13 and 17 years of age at the time of the first vaccination.
  • Written informed consent obtained from the subject's parent(s) or legal guardian(s).
  • Written informed assent obtained from the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Seronegative for HIV-1.
  • No history of TB disease.
  • No active pulmonary disease on chest X-ray.
  • Availability for the duration of the immunisation and follow-up period, with the family not planning to move away from the study area within the next year.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject is abstinent, has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire vaccination period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Administration of a registered live vaccine not foreseen by the study within 30 days preceding the first dose of study vaccine and administration of a registered inactivated vaccine within 14 days preceding the first dose of study vaccine.
  • History of previous administration of investigational Mycobacterium tuberculosis vaccines.
  • History of previous exposure to components of the investigational vaccine.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Any condition or illness (acute, chronic or history) or medication, which in the opinion of the investigator might interfere with the evaluation of the safety or immunogenicity of the study vaccine.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of vaccine, or planned administration during the study.
  • Planned participation or participation in another experimental clinical study during the study period.
  • A family history of congenital or hereditary immunodeficiency.
  • Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements, birth control pills, anti-histamines for seasonal allergies and Specific Serotonin Reuptake Inhibitors (SSRIs).
  • History of allergic reactions (significant IgE-mediated events) or anaphylaxis to any vaccine.
  • History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
  • Pregnant female, lactating female or female planning to become pregnant or discontinue contraceptive precautions.
  • Drug and/or alcohol abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00950612

Locations
South Africa
GSK Investigational Site
Worcester, Western Province, South Africa, 6850
Sponsors and Collaborators
GlaxoSmithKline
Aeras
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: NCT00950612     History of Changes
Other Study ID Numbers: 112898
Study First Received: July 23, 2009
Last Updated: June 23, 2011
Health Authority: South Africa: Medicines Control Council

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 23, 2014