TuberculosisPhase 2NCT01424501

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

A Phase 2 study testing GSK Biologicals' investigational TB vaccine GSK 692342 in people with Tuberculosis, run by GlaxoSmithKline at 6 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for: Tuberculosis
What is being tested?: GSK Biologicals' investigational TB vaccine GSK 692342
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 142 participants
Where: 6 sitesin 2 countries
Study dates: 14 Nov 2011to 10 Apr 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 59 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Show all 18Show fewer

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.

Who cannot join

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.

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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.

Trial locations and contacts

6 sites in 2 countries.

Country

City, postcode or hospital

6 sites in 2 countries

Taiwan4 sites

GSK Investigational Site
Taipei, 100
GSK Investigational Site
Taipei, 220
GSK Investigational Site
Taipei
GSK Investigational Site
Taoyuan Hsien, 333

Other trials in Taiwan

Estonia2 sites

GSK Investigational Site
Tallinn, 10117
GSK Investigational Site
Tartu, 51014

Other trials in Estonia

About this study

Official title: Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342 When Administered to Adults With TB Disease

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.

Read the 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
Being tested: GSK Biologicals' investigational TB vaccine GSK 692342, Placebo
Keywords: Tuberculosis vaccine, HIV-negative, tuberculosis treatment
Medical subject headings: Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK Biologicals' investigational TB vaccine GSK 692342Biological
Intramuscular injection, 2 doses
PlaceboBiological
Intramuscular injection, 2 doses

Study groups in NCT01424501
Study group	Role	What they receive
Group A	Experimental	Subjects from TB-treated cohort will receive 2 doses of GSK's investigational vaccine GSK 692342. Receives: Biological: GSK Biologicals' investigational TB vaccine GSK 692342
Group B	Placebo comparator	Subjects from TB-treated cohort will receive 2 doses of physiological Saline. Receives: Biological: Placebo
Group C	Experimental	Subjects from TB-treatment cohort will receive 2 doses of GSK's investigational vaccine GSK 692342. Receives: Biological: GSK Biologicals' investigational TB vaccine GSK 692342
Group D	Placebo comparator	Subjects from TB-treatment cohort will receive 2 doses of physiological Saline. Receives: Biological: Placebo
Group E	Experimental	Subjects from TB-naive cohort will receive 2 doses of GSK's investigational vaccine GSK 692342. Receives: Biological: GSK Biologicals' investigational TB vaccine GSK 692342
Group F	Placebo comparator	Subjects from TB-naive cohort will receive 2 doses of physiological Saline. Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = redness/swelling spreading beyond (>) 100 millimeters (mm) of injection site.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, malaise, myalgia and temperature [body temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any solicited general symptom regardless of their intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = body temperature above (>) 39.5°C. Related = event assessed by the investigator as causally related to the study vaccination.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: During the 30 day (Days 0-29), after vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: Up to day 210

Secondary outcomes (22)

Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies
Cut-off values assessed were greater than or equal to (≥) 2.8, as measured by Enzyme-Linked Immunosorbent Assay (ELISA) in the sera of subjects seronegative before vaccination.
Measured: Prior to dose 1 (Day 0), post-dose 1 (Day 30), post-dose 2 (Days 60 and 210)
Concentrations of Anti-M72 Antibodies
Concentrations are presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EU/mL).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Day 30), post-dose 2 (Days 60 and 210)
Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a), CD40-ligand (CD40-L), Interleukin-17 (IL-17) and/or Interleukin-13 (IL-13).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines
Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines
Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination
Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination
Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a), CD40-ligand (CD40-L), Interleukin-17 (IL-17) and/or Interleukin-13 (IL-13).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines
Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Immune Markers
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines
Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination
Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD8+ T-cells Expressing Immune Markers in Any Combination
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination
Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination
Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).
Measured: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Nov 201110 Apr 2014

First posted29 Aug 2011 (estimated)
Study start14 Nov 2011
Primary completion1 Apr 2014
Study completion10 Apr 2014

Why it stopped: Due to a safety signal found at a planned interim safety review, further conduct of this safety study is not recommended hence the study was terminated.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for TuberculosisStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01424501
Sponsor's protocol ID: 114886
Status last verified: Jul 2018
First submitted: 25 Aug 2011
Last updated: 20 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

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.
PubMed 36355775
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.
PubMed 27553419

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Tuberculosis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342 When Administered to Adults With TB Disease
ClinicalTrials.gov ID: NCT01424501
Acronym / sponsor ID: 114886
Conditions: Tuberculosis
Keywords: Tuberculosis vaccine, HIV-negative, tuberculosis treatment
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to a safety signal found at a planned interim safety review, further conduct of this safety study is not recommended hence the study was terminated.
Enrolment: 142 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 14 Nov 2011 (actual)
Primary completion: 1 Apr 2014 (actual)
Study completion: 10 Apr 2014 (actual)
First posted: 29 Aug 2011 (estimated)
Results: Posted 24 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Group A	Experimental	Biological: GSK Biologicals' investigational TB vaccine GSK 692342Subjects from TB-treated cohort will receive 2 doses of GSK's investigational vaccine GSK 692342.
Group B	Placebo comparator	Biological: PlaceboSubjects from TB-treated cohort will receive 2 doses of physiological Saline.
Group C	Experimental	Biological: GSK Biologicals' investigational TB vaccine GSK 692342Subjects from TB-treatment cohort will receive 2 doses of GSK's investigational vaccine GSK 692342.
Group D	Placebo comparator	Biological: PlaceboSubjects from TB-treatment cohort will receive 2 doses of physiological Saline.
Group E	Experimental	Biological: GSK Biologicals' investigational TB vaccine GSK 692342Subjects from TB-naive cohort will receive 2 doses of GSK's investigational vaccine GSK 692342.
Group F	Placebo comparator	Biological: PlaceboSubjects from TB-naive cohort will receive 2 doses of physiological Saline.

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (18 listed)

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:

Key exclusion criteria (18 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK Biologicals' investigational TB vaccine GSK 692342Intramuscular injection, 2 doses	Biological	Group A, Group C, Group E
PlaceboIntramuscular injection, 2 doses	Biological	Group B, Group D, Group F

Primary outcome

Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = redness/swelling spreading beyond (>) 100 millimeters (mm) of injection site.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, malaise, myalgia and temperature [body temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any solicited general symptom regardless of their intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = body temperature above (>) 39.5°C. Related = event assessed by the investigator as causally related to the study vaccination.
Number of Subjects With Adverse Events (AEs)
Time frame: During the 30 day (Days 0-29), after vaccination
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: Up to day 210
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

22 secondary outcomes

Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Day 30), post-dose 2 (Days 60 and 210)
Concentrations of Anti-M72 Antibodies
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Day 30), post-dose 2 (Days 60 and 210)
Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Immune Markers
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of M72-specific CD8+ T-cells Expressing Immune Markers in Any Combination
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)
Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination
Time frame: Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)

Results and safety

Results posted to the registry on 24 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TB Treatment GSK 692342 Group	7	6
TB Treatment Saline Group	6	5
TB Treated GSK 692342 Group	24	22
TB Treated Saline Group	25	25
TB Naive GSK 692342 Group	40	40
TB Naive Saline Group	40	40

Primary outcome: Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses. Count of participants. Unit: Participants

Measure	TB Treatment GSK 692342 Group n = 7	TB Treatment Saline Group n = 6	TB Treated GSK 692342 Group n = 24	TB Treated Saline Group n = 25	TB Naive GSK 692342 Group n = 40	TB Naive Saline Group n = 40
Any Pain, Dose 1	6	1	21	2	38	5
Grade 3 Pain, Dose 1	0	0	3	0	0	0
Any Redness, Dose 1	2	0	4	0	7	0
Grade 3 Redness, Dose 1	0	0	2	0	0	0
Any Swelling, Dose 1	2	0	5	1	4	0
Grade 3 Swelling, Dose 1	0	0	1	0	0	0
Any Pain, Dose 2	5	1	19	1	36	6
Grade 3 Pain, Dose 2	0	0	5	0	5	0

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administered, for whom data were available and who had their symptom sheets filled in.

Primary outcome: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses. Count of participants. Unit: Participants

Measure	TB Treatment GSK 692342 Group n = 7	TB Treatment Saline Group n = 6	TB Treated GSK 692342 Group n = 24	TB Treated Saline Group n = 25	TB Naive GSK 692342 Group n = 40	TB Naive Saline Group n = 40
Any Fatigue, Dose 1	1	2	14	6	19	8
Grade 3 Fatigue, Dose 1	1	0	9	3	16	7
Related Fatigue, Dose 1	0	1	2	0	2	1
Any Gastrointestinal symptoms, Dose 1	0	0	4	2	5	5
Grade 3 Gastrointestinal symptoms, Dose 1	0	0	1	0	3	3
Related Gastrointestinal symptoms, Dose 1	0	0	2	0	0	0
Any Headache, Dose 1	1	0	11	4	8	5
Grade 3 Headache, Dose 1	1	0	4	1	7	5

Primary outcome: Number of Subjects With Adverse Events (AEs)

Time frame: During the 30 day (Days 0-29), after vaccination. Number. Unit: Subjects

Measure	TB Treatment GSK 692342 Group n = 7	TB Treatment Saline Group n = 6	TB Treated GSK 692342 Group n = 24	TB Treated Saline Group n = 25	TB Naive GSK 692342 Group n = 40	TB Naive Saline Group n = 40
Value	1	2	14	7	19	8

Population analysed: The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered and for whom data were available.

Primary outcome: Number of Subjects With Serious Adverse Events (SAEs)

Time frame: Up to day 210. Number. Unit: Subjects

Measure	TB Treatment GSK 692342 Group n = 7	TB Treatment Saline Group n = 6	TB Treated GSK 692342 Group n = 24	TB Treated Saline Group n = 25	TB Naive GSK 692342 Group n = 40	TB Naive Saline Group n = 40
Value	0	0	2	2	1	0

Population analysed: The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered and for whom data were available.

22 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 210.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TB Treatment GSK 692342 Group	0 of 7 (0%)	6 of 7 (85.7%)	0 of 7
TB Treatment Saline Group	0 of 6 (0%)	3 of 6 (50%)	0 of 6
TB Treated GSK 692342 Group	2 of 24 (8.3%)	24 of 24 (100%)	0 of 24
TB Treated Saline Group	2 of 25 (8%)	14 of 25 (56%)	0 of 25
TB Naive GSK 692342 Group	1 of 40 (2.5%)	40 of 40 (100%)	0 of 40
TB Naive Saline Group	0 of 40 (0%)	26 of 40 (65%)	0 of 40

Limitations and caveats (from the sponsor): Due to a safety signal found at a planned interim safety review, further conduct of this safety study is not recommended hence the study was terminated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36355775Coccia 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.
Derived from this study: PubMed 27553419Gillard 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.
IPD for this study will be made available via the Clinical Study Data Request site.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

6 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK Biologicals' investigational TB vaccine GSK 692342 in people with Tuberculosis, run by GlaxoSmithKline at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Taiwan, Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Any and Grade 3 Solicited Local Symptoms (time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01424501, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.