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Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults

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ClinicalTrials.gov Identifier: NCT01755598
Recruitment Status : Active, not recruiting
First Posted : December 24, 2012
Last Update Posted : October 15, 2018
Sponsor:
Collaborator:
Aeras
Information provided by (Responsible Party):
GlaxoSmithKline

December 19, 2012
December 24, 2012
October 15, 2018
August 19, 2014
November 25, 2018   (Final data collection date for primary outcome measure)
Incident cases of definite pulmonary TB disease not associated with HIV-infection meeting the first case definition. [ Time Frame: Over a period starting 1 month post dose 2 (Month 2) and lasting up to 35 months post last vaccination (Month 36). ]
Same as current
Complete list of historical versions of study NCT01755598 on ClinicalTrials.gov Archive Site
  • Incident cases of definite Xpert MTB/RIF pulmonary TB disease not associated with HIV-infection, meeting the second case definition. [ Time Frame: Over a period starting 1 month post dose 2 (Month 2) and lasting up to 35 months post last vaccination (Month 36). ]
  • Incident cases of definite pulmonary TB disease meeting the third case definition. [ Time Frame: Over a period starting 1 month post dose 2 (Month 2) and lasting up to 35 months post last vaccination (Month 36). ]
  • Incident cases of Microbiological Pulmonary TB disease meeting the fourth case definition. [ Time Frame: Over a period starting 1 month post dose 2 (Month 2) and lasting up to 35 months post last vaccination (Month 36). ]
  • Incident cases of clinical TB disease meeting the fifth case definition. [ Time Frame: Over a period starting 1 month post dose 2 (Month 2) and lasting up to 35 months post last vaccination (Month 36). ]
  • Occurrence of serious adverse events. [ Time Frame: During the entire study period (Day 0 to Month 36). ]
  • Occurrence of unsolicited adverse events. [ Time Frame: During the 30 day follow-up period following vaccination (day of vaccination and 29 subsequent days after each vaccine dose). ]
  • Occurrence of solicited local and general adverse events in the safety and immune sub-cohort. [ Time Frame: During the 7 day follow-up period following vaccination (day of vaccination and 6 subsequent days after each vaccine dose). ]
  • Occurrence of all potential immune-mediated diseases (pIMDs). [ Time Frame: Over a period starting at Day 0 until 6 months post dose 2 (Month 7). ]
  • Evaluation of Cell-mediated Immune (CMI) responses in the safety and immune sub-cohort in terms of frequency of M72-specific CD4+/CD8+ T cells expressing TNF-α and/or IFN-γ and/or IL-2 and/or CD40L per million cells identified after in vitro stimulation. [ Time Frame: Prior to dose 1 (Day 0), 1 month post dose 2 (Day 60) and Years 1, 2 and 3. ]
  • Evaluation of humoral responses with respect to components of the study vaccine, in the safety and immune sub-cohort in terms of M72-specific antibody titres and seropositivity rates as measured by ELISA. [ Time Frame: Prior to dose 1 (Day 0), 1 month post dose 2 (Day 60) and Years 1, 2 and 3. ]
  • Occurrence of grade ≥ 2 haematological and biochemical levels in the safety and immune sub-cohort. [ Time Frame: Days 0, 7, 30 and 37. ]
  • Incident cases of definite Xpert MTB/RIF pulmonary TB disease not associated with HIV-infection, meeting the second case definition. [ Time Frame: Over a period starting 1 month post dose 2 (Month 2) and lasting up to 35 months post last vaccination (Month 36). ]
  • Incident cases of definite pulmonary TB disease meeting the third case definition. [ Time Frame: Over a period starting 1 month post dose 2 (Month 2) and lasting up to 35 months post last vaccination (Month 36). ]
  • Incident cases of definite pulmonary TB disease meeting the fourth case definition. [ Time Frame: Over a period starting 1 month post dose 2 (Month 2) and lasting up to 35 months post last vaccination (Month 36). ]
  • Incident cases of clinical TB disease meeting the fifth case definition. [ Time Frame: Over a period starting 1 month post dose 2 (Month 2) and lasting up to 35 months post last vaccination (Month 36). ]
  • Occurrence of serious adverse events. [ Time Frame: During the entire study period (Day 0 to Month 36). ]
  • Occurrence of unsolicited adverse events. [ Time Frame: During the 30 day follow-up period following vaccination (day of vaccination and 29 subsequent days after each vaccine dose). ]
  • Occurrence of solicited local and general adverse events in the safety and immune sub-cohort. [ Time Frame: During the 7 day follow-up period following vaccination (day of vaccination and 6 subsequent days after each vaccine dose). ]
  • Occurrence of all potential immune-mediated diseases (pIMDs). [ Time Frame: Over a period starting at Day 0 until 6 months post dose 2 (Month 7). ]
  • Evaluation of Cell-mediated Immune (CMI) responses in the safety and immune sub-cohort in terms of frequency of M72-specific CD4+/CD8+ T cells expressing TNF-α and/or IFN-γ and/or IL-2 and/or CD40L per million cells identified after in vitro stimulation. [ Time Frame: Prior to dose 1 (Day 0), 1 month post dose 2 (Day 60) and Years 1, 2 and 3. ]
  • Evaluation of humoral responses with respect to components of the study vaccine, in the safety and immune sub-cohort in terms of M72-specific antibody titres and seropositivity rates as measured by ELISA. [ Time Frame: Prior to dose 1 (Day 0), 1 month post dose 2 (Day 60) and Years 1, 2 and 3. ]
Not Provided
Not Provided
 
Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults
Efficacy of GSK Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342 Against TB Disease, in Adults Living in a TB Endemic Region
The purpose of this study is to evaluate the protective efficacy of two doses of GSK Biologicals' candidate TB vaccine against pulmonary TB, as compared to placebo. The efficacy will be evaluated in adults living in TB endemic countries and aged 18 - 50 years because pulmonary TB occurs frequently in these countries and age range. In addition, the safety and immunogenicity of the candidate tuberculosis vaccine will be evaluated in a subset of volunteers.

Case Definitions:

• First case definition: A subject with clinical suspicion of pulmonary TB disease, with MTB complex identified from a sputum specimen, taken before initiation of TB treatment, by Xpert MTB/RIF and/or microbiological culture and confirmed HIV-negative at the time of TB diagnosis.

• Second case definition: A subject with clinical suspicion of pulmonary TB disease, with MTB complex identified from a sputum specimen, taken before initiation of TB treatment, by Xpert MTB/RIF and confirmed HIV-negative at the time of TB diagnosis.

• Third case definition: A subject with clinical suspicion of pulmonary TB disease, with MTB complex identified from a sputum specimen, taken up to four weeks after initiation of TB treatment, by Xpert MTB/RIF and/or microbiological culture and confirmed HIV-negative at the time of TB diagnosis.

• Fourth case definition: A subject with clinical suspicion of pulmonary TB disease, with MTB complex identified from a sputum specimen, taken up to four weeks after initiation of TB treatment, by Xpert MTB/RIF and/or microbiological culture.

• Fifth case definition: A subject for whom a clinician has diagnosed TB disease and has decided to treat the patient with TB treatment.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Tuberculosis
  • Biological: GSK Biologicals' investigational TB vaccine (GSK692342)
    2 doses administered intramuscularly in the deltoid region of the arm.
  • Biological: Placebo
    2 doses administered intramuscularly in the deltoid region of the arm.
  • Experimental: Vaccine group
    Subjects will receive 2 doses of the candidate tuberculosis vaccine (Day 0 and Day 30).
    Intervention: Biological: GSK Biologicals' investigational TB vaccine (GSK692342)
  • Placebo Comparator: Control group
    Subjects will receive 2 doses of placebo (Day 0 and Day 30).
    Intervention: Biological: Placebo
Van Der Meeren O, Hatherill M, Nduba V, Wilkinson RJ, Muyoyeta M, Van Brakel E, Ayles HM, Henostroza G, Thienemann F, Scriba TJ, Diacon A, Blatner GL, Demoitié MA, Tameris M, Malahleha M, Innes JC, Hellström E, Martinson N, Singh T, Akite EJ, Khatoon Azam A, Bollaerts A, Ginsberg AM, Evans TG, Gillard P, Tait DR. Phase 2b Controlled Trial of M72/AS01(E) Vaccine to Prevent Tuberculosis. N Engl J Med. 2018 Oct 25;379(17):1621-1634. doi: 10.1056/NEJMoa1803484. Epub 2018 Sep 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3506
7000
November 25, 2018
November 25, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who, in the opinion of the investigator, 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 obtaining informed consent.
  • Written (or thumb printed and witnessed) informed consent obtained from the subject.
  • Baseline positive IGRA test result.
  • Baseline negative HIV screen.
  • Baseline negative clinical screening questionnaire and negative sputum sample for Pulmonary TB disease.
  • Healthy subjects or those with chronic well-controlled disease as established by medical history and clinical examination.
  • Female subjects of non-childbearing potential may be enrolled in the study.

    • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 25 days prior to vaccination, and
    • has a negative pregnancy test on the day of screening and the day of first 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:

  • Current TB disease or history of TB disease and/or treatment for TB.
  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after each dose of vaccine.
  • History of previous administration of experimental Mtb vaccines.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
  • Any condition or illness or medication, which in the opinion of the Investigator might interfere with the evaluation of the safety or immunogenicity of the vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Planned participation or participation in another experimental protocol during the study.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • History of medically confirmed autoimmune disease.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions during the vaccination period and/or before 2 months after completion of the vaccination series.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya,   South Africa,   Zambia
 
 
NCT01755598
115616
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Aeras
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP