Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-positive Adults.
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00707967
First received: June 27, 2008
Last updated: April 14, 2011
Last verified: April 2011
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This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine (692342) administered at 0, 1 month to HIV-positive adults living in Switzerland.
Condition | Intervention | Phase |
---|---|---|
Tuberculosis (TB) |
Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342 Biological: Control vaccine with the adjuvant system. Biological: Control vaccine with physiological saline |
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 of a Candidate Tuberculosis (TB) Vaccine (692342) in HIV-positive Adults. |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Occurrence, intensity and relationship to vaccination of solicited local and general adverse events [ Time Frame: During the 7-day follow-up period following vaccination after each vaccine dose. ] [ Designated as safety issue: No ]
- Occurrence, intensity and relationship to vaccination of unsolicited adverse events. [ Time Frame: During the 30-day follow-up period following vaccination after each vaccine dose. ] [ Designated as safety issue: No ]
- Occurrence and relationship to vaccination of serious adverse events [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]
- Haematological and biochemical levels [ Time Frame: Prior to, one week and one month after each vaccination ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Analysis of cytokine/activation marker expression by antigen-specific CD4+/CD8+ T cells by means of in vitro flow cytometry. [ Time Frame: Prior to each vaccination and one month and 6 months after the last dose ] [ Designated as safety issue: No ]
- Antigen-specific antibody titres as measured by ELISA. [ Time Frame: Prior to each vaccination and one month and 6 months after the last dose ] [ Designated as safety issue: No ]
Enrollment: | 37 |
Study Start Date: | June 2008 |
Study Completion Date: | May 2009 |
Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Group A
Subjects receiving the candidate vaccine
|
Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342
Intramuscular injection, 2 doses at 0, 1 month
|
Placebo Comparator: Group B
Subjects receiving the adjuvant
|
Biological: Control vaccine with the adjuvant system.
Intramuscular injection, 2 doses at 0, 1 month
|
Placebo Comparator: Group C
Subjects receiving physiological saline
|
Biological: Control vaccine with physiological saline
Intramuscular injection, 2 doses at 0, 1 month
|
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects who the Investigator believes that they can and will comply with the requirements of the protocol.
- A male or female between, and including, 18 and 50 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject prior to any study procedure.
Subjects must be HIV-positive and must have:
- received Highly Active Antiretroviral therapy for a minimum of 12 consecutive months prior to screening
- documented suppressed HIV-1 RNA levels following HAART-treatment.
- a protocol defined CD4+ T cell count at screening
- If the subject is female, she must be of non-childbearing potential, or she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of vaccination.
- Clinically acceptable laboratory values prior to randomisation as determined by the Investigator.
- No evidence of TB disease with no pulmonary pathology as confirmed by chest X-ray.
- No history of extrapulmonary TB.
- No history of chemotherapy for TB.
Exclusion Criteria:
- Any change in antiretroviral drug regimen within 12 weeks prior to screening.
- 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 experimental Mycobacterium tuberculosis vaccines.
- History of previous exposure to experimental products containing components of the experimental vaccine.
- Chronic administration of immunosuppressive or other immune-modifying drugs within six months prior to the first vaccine dose.
- Administration of any immunoglobulins, any immunotherapy and/or any blood products within the three months preceding the first dose of study vaccination, or planned administrations during the study period.
- 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 vaccine.
- Planned participation or participation in another experimental protocol during the study period.
- A family history of congenital or hereditary immunodeficiency. •Any chronic drug therapy, other than HAART or prophylaxis for opportunistic HIV-related infections to be continued during the study period. Vitamins and/or dietary supplements, birth control pills, anti-histamines for seasonal allergies and SSRIs are allowed.
- Subjects taking any of the following medication: systemic steroids, interleukins, systemic interferons or systemic chemotherapy.
- History of allergic reactions or anaphylaxis to any vaccine.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- History of chronic alcohol consumption and/or drug abuse which in the Investigator's opinion would put the subject at risk.
- Pregnant female, lactating female or female planning to become pregnant or stop contraception.
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No publications provided
Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
ClinicalTrials.gov Identifier: | NCT00707967 History of Changes |
Other Study ID Numbers: | 111517 |
Study First Received: | June 27, 2008 |
Last Updated: | April 14, 2011 |
Health Authority: | Switzerland: Swissmedic |
Keywords provided by GlaxoSmithKline:
Tuberculosis vaccine |
Additional relevant MeSH terms:
HIV Seropositivity Tuberculosis HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 03, 2013