Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Adults With TB Disease

NCT ID: NCT01424501

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-14
• Study Completion Date: 2014-04-10

Brief Summary

This study will assess the safety and immunogenicity of GSK Biologicals' investigational tuberculosis (TB) vaccine (GSK 692342) compared to placebo when administered at 0, 1 months to human immunodeficiency virus (HIV) negative adults who have received treatment for TB disease (denoted TB-treated cohort) or are currently receiving treatment for TB disease (denoted TB-treatment cohort). For comparative purposes, subjects who have never had TB disease (denoted TB-naïve cohort) will also be enrolled.

Detailed Description

A Protocol Amendment 1, May 2012, was made following the decision to add a second country in the study (i.e. Estonia).

Conditions

Tuberculosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group A

Subjects from TB-treated cohort will receive 2 doses of GSK's investigational vaccine GSK 692342.

Group Type: EXPERIMENTAL

GSK Biologicals' investigational TB vaccine GSK 692342

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses

Group B

Subjects from TB-treated cohort will receive 2 doses of physiological Saline.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses

Group C

Subjects from TB-treatment cohort will receive 2 doses of GSK's investigational vaccine GSK 692342.

Group Type: EXPERIMENTAL

GSK Biologicals' investigational TB vaccine GSK 692342

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses

Group D

Subjects from TB-treatment cohort will receive 2 doses of physiological Saline.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses

Group E

Subjects from TB-naive cohort will receive 2 doses of GSK's investigational vaccine GSK 692342.

Group Type: EXPERIMENTAL

GSK Biologicals' investigational TB vaccine GSK 692342

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses

Group F

Subjects from TB-naive cohort will receive 2 doses of physiological Saline.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses

Interventions

GSK Biologicals' investigational TB vaccine GSK 692342

Intramuscular injection, 2 doses

Intervention Type: BIOLOGICAL

Placebo

Intramuscular injection, 2 doses

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes can and will comply with the requirements of the protocol.
• A male or female between, and including, 18 and 59 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject.
• 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:

• 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 treatment period and for 2 months after completion of the vaccination series.
• Seronegative for HIV- 1 and -2 antibodies.
• No history of or current extrapulmonary tuberculosis TB. Additionally, based on medical history,
• Subjects in the TB-naive cohort must

• have no active pulmonary disease as indicated by chest X-ray.
• have no signs and symptoms of TB.
• have no history of chemoprophylaxis or treatment for TB.
• Subjects in the TB-treated cohort must

• have a history of successful treatment for pulmonary TB (completed at least 1 year prior to vaccination).
• have no active pulmonary disease on chest X-ray.
• Subjects in the TB-treatment cohort must - have documented treatment for pulmonary TB (smear- or culture confirmed) ongoing for 2-4 months prior to vaccination.

Exclusion Criteria

• Use of any investigational or non-registered product 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.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Any chronic drug therapy to be continued during the study period, which in the opinion of the investigator could adversely interfere with the vaccine.
• History of previous administration of experimental TB vaccines.
• History of previous exposure to components of the investigational vaccine within 30 days preceding the first dose of study vaccine.
• Administration of any immunoglobulins, any immunotherapy and/or any blood products within the 3 months preceding the first dose of study vaccination, or planned administrations during the study period.
• Planned participation or participation in another experimental protocol during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• History of chronic alcohol and/or drug abuse.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Major congenital defects.
• Pregnant female, lactating female or female planning to become pregnant or discontinue contraceptive precautions during the active phase of the study (from study start till 2 months after dose 2).
• Additionally, for the TB naïve and TB treated cohorts:

• Acute or chronic clinically relevant pulmonary, cardiovascular, hepatic or renal function abnormality as determined by physical examination or laboratory screening tests
• Additionally, for the TB treatment cohort:

• Acute or chronic clinically relevant pulmonary, cardiovascular, hepatic or renal function abnormality as determined by physical examination or laboratory screening tests. Individuals with grade 3 levels will be excluded.
• Failure to convert while on anti-TB treatment at the end of the second month of anti-TB therapy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tartu, , Estonia

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taoyuan Hsien, , Taiwan

Countries

Estonia; Taiwan

References

Coccia M, Burny W, Demoitie MA, Gillard P, van den Berg RA, van der Most R. Subsequent AS01-adjuvanted vaccinations induce similar transcriptional responses in populations with different disease statuses. PLoS One. 2022 Nov 10;17(11):e0276505. doi: 10.1371/journal.pone.0276505. eCollection 2022.

Reference Type: DERIVED

PMID: 36355775 (View on PubMed)

Gillard P, Yang PC, Danilovits M, Su WJ, Cheng SL, Pehme L, Bollaerts A, Jongert E, Moris P, Ofori-Anyinam O, Demoitie MA, Castro M. Safety and immunogenicity of the M72/AS01E candidate tuberculosis vaccine in adults with tuberculosis: A phase II randomised study. Tuberculosis (Edinb). 2016 Sep;100:118-127. doi: 10.1016/j.tube.2016.07.005. Epub 2016 Jul 21.

Reference Type: DERIVED

PMID: 27553419 (View on PubMed)

Related Links

https://clinicalstudydatarequest.com

IPD for this study will be made available via the Clinical Study Data Request site.

Other Identifiers

114886

Identifier Type: -

Identifier Source: org_study_id