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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.
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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.
A Protocol Amendment 1, May 2012, was made following the decision to add a second country in the study (i.e. Estonia).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects from TB-treated cohort will receive 2 doses of GSK's investigational vaccine GSK 692342. |
|
| Group B | Placebo Comparator | Subjects from TB-treated cohort will receive 2 doses of physiological Saline. |
|
| Group C | Experimental | Subjects from TB-treatment cohort will receive 2 doses of GSK's investigational vaccine GSK 692342. |
|
| Group D | Placebo Comparator | Subjects from TB-treatment cohort will receive 2 doses of physiological Saline. |
|
| Group E | Experimental | Subjects from TB-naive cohort will receive 2 doses of GSK's investigational vaccine GSK 692342. |
|
| Group F |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biologicals' investigational TB vaccine GSK 692342 | Biological | Intramuscular injection, 2 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Up to day 210 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Prior to dose 1 (Day 0), post-dose 1 (Day 30), post-dose 2 (Days 60 and 210) |
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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:
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
Subjects in the TB-treated cohort must
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:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Tallinn | 10117 | Estonia | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36355775 | Derived | 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. | |
| 27553419 | Derived |
| Label | URL |
|---|---|
| IPD for this study will be made available via the Clinical Study Data Request site. | View source |
Not provided
IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
During the screening the following was performed: informed consent was obtained and signed from parents or guardians of subjects, check for inclusion/exclusion criteria and contraindications/precautions, and medical history of subjects was collected. Prior to vaccination, subjects' pre-vaccination body temperature was evaluated.
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| ID | Title | Description |
|---|---|---|
| FG000 | TB Treatment GSK 692342 Group | Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1. |
| FG001 | TB Treatment Saline Group | Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1. |
| FG002 | TB Treated GSK 692342 Group | Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1. |
| FG003 | TB Treated Saline Group | Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1. |
| FG004 | TB Naive GSK 692342 Group | Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1. |
| FG005 | TB Naive Saline Group | Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TB Treatment GSK 692342 Group | Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1. |
| BG001 | TB Treatment Saline Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses |
|
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.
Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TB Treatment GSK 692342 Group | Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal fistula | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic enzyme increased | Investigations | MedDRA 18.0 | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| Placebo Comparator |
Subjects from TB-naive cohort will receive 2 doses of physiological Saline. |
|
| Placebo | Biological | Intramuscular injection, 2 doses |
|
| Concentrations of Anti-M72 Antibodies |
Concentrations are presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EU/mL). |
| 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
| Tartu |
| 51014 |
| Estonia |
| GSK Investigational Site | Taipei | 100 | Taiwan |
| GSK Investigational Site | Taipei | 220 | Taiwan |
| GSK Investigational Site | Taipei | Taiwan |
| GSK Investigational Site | Taoyuan Hsien | 333 | Taiwan |
| 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. |
| Lost to Follow-up |
|
Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1. |
| BG002 | TB Treated GSK 692342 Group | Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1. |
| BG003 | TB Treated Saline Group | Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1. |
| BG004 | TB Naive GSK 692342 Group | Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1. |
| BG005 | TB Naive Saline Group | Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1. |
| BG006 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | TB Treatment Saline Group | Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1. |
| OG002 | TB Treated GSK 692342 Group | Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1. |
| OG003 | TB Treated Saline Group | Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1. |
| OG004 | TB Naive GSK 692342 Group | Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1. |
| OG005 | TB Naive Saline Group | Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1. |
|
|
| Primary | 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. | 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 symptoms sheets filled in. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses |
|
|
|
| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered and for whom data were available. | Posted | Number | Subjects | During the 30 day (Days 0-29), after vaccination |
|
|
|
| Primary | 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. | The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered and for whom data were available. | Posted | Number | Subjects | Up to day 210 |
|
|
|
| Secondary | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity,which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules,receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Count of Participants | Participants | Prior to dose 1 (Day 0), post-dose 1 (Day 30), post-dose 2 (Days 60 and 210) |
|
|
|
| Secondary | Concentrations of Anti-M72 Antibodies | Concentrations are presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EU/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Prior to dose 1 (Day 0), post-dose 1 (Day 30), post-dose 2 (Days 60 and 210) |
|
|
|
| Secondary | 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). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Median | Inter-Quartile Range | CD4+ T-cells/million cells | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
|
|
|
| Secondary | 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). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Median | Inter-Quartile Range | CD4+ T-cells/million cells | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
|
|
|
| Secondary | 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). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Median | Inter-Quartile Range | CD4+ T-cells/million cells | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
|
|
|
| Secondary | 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). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Median | Inter-Quartile Range | CD4+ T-cells/million cells | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
|
|
|
| Secondary | 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). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Median | Inter-Quartile Range | CD4+ T-cells/million cells | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
|
|
|
| Secondary | 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). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Median | Inter-Quartile Range | CD4+ T-cells/million cells | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
|
|
|
| Secondary | 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). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Median | Inter-Quartile Range | CD4+ T-cells/million cells | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
|
|
|
| Secondary | 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). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Median | Inter-Quartile Range | CD4+ T-cells/million cells | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
|
|
|
| Secondary | 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). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Median | Inter-Quartile Range | CD4+ T-cells/million cells | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
|
|
|
| Secondary | 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). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Median | Inter-Quartile Range | CD4+ T-cells/million cells | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
|
|
|
| Secondary | 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). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Median | Inter-Quartile Range | CD8+ T-cells/million cells | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
|
|
|
| Secondary | 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). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Median | Inter-Quartile Range | CD8+ T-cells/million cells | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
|
|
|
| Secondary | 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). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Median | Inter-Quartile Range | CD8+ T-cells/million cells | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
|
|
|
| Secondary | 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). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Median | Inter-Quartile Range | CD8+ T-cells/million cells | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
|
|
|
| Secondary | 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). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Median | Inter-Quartile Range | CD8+ T-cells/million cells | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
|
|
|
| Secondary | 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). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Median | Inter-Quartile Range | CD8+ T-cells/million cells | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
|
|
|
| Secondary | 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). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Median | Inter-Quartile Range | CD8+ T-cells/million cells | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
|
|
|
| Secondary | 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). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Median | Inter-Quartile Range | CD8+ T-cells/million cells | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
|
|
|
| Secondary | 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). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Median | Inter-Quartile Range | CD8+ T-cells/million cells | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
|
|
|
| Secondary | 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). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination. | Posted | Median | Inter-Quartile Range | CD8+ T-cells/million cells | Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210) |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 6 |
| 7 |
| EG001 | TB Treatment Saline Group | Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG002 | TB Treated GSK 692342 Group | Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1. | 0 | 24 | 2 | 24 | 24 | 24 |
| EG003 | TB Treated Saline Group | Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1. | 0 | 25 | 2 | 25 | 14 | 25 |
| EG004 | TB Naive GSK 692342 Group | Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1. | 0 | 40 | 1 | 40 | 40 | 40 |
| EG005 | TB Naive Saline Group | Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1. | 0 | 40 | 0 | 40 | 26 | 40 |
| Calculus ureteric | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Gastrointestinal symptoms | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Grade 3 Fatigue, Dose 1 |
|
|
| Related Fatigue, Dose 1 |
|
|
| Any Gastrointestinal symptoms, Dose 1 |
|
|
| Grade 3 Gastrointestinal symptoms, Dose 1 |
|
|
| Related Gastrointestinal symptoms, Dose 1 |
|
|
| Any Headache, Dose 1 |
|
|
| Grade 3 Headache, Dose 1 |
|
|
| Related Headache, Dose 1 |
|
|
| Any Malaise, Dose 1 |
|
|
| Grade 3 Malaise, Dose 1 |
|
|
| Related Malaise, Dose 1 |
|
|
| Any Myalgia, Dose 1 |
|
|
| Grade 3 Myalgia, Dose 1 |
|
|
| Related Myalgia, Dose 1 |
|
|
| Any Temperature/(Axillary), Dose 1 |
|
|
| Grade 3 Temperature/(Axillary), Dose 1 |
|
|
| Related Temperature/(Axillary), Dose 1 |
|
|
| Any Fatigue, Dose 2 |
|
|
| Grade 3 Fatigue, Dose 2 |
|
|
| Related Fatigue, Dose 2 |
|
|
| Any Gastrointestinal symptoms, Dose 2 |
|
|
| Grade 3 Gastrointestinal symptoms, Dose 2 |
|
|
| Related Gastrointestinal symptoms, Dose 2 |
|
|
| Any Headache, Dose 2 |
|
|
| Grade 3 Headache, Dose 2 |
|
|
| Related Headache, Dose 2 |
|
|
| Any Malaise, Dose 2 |
|
|
| Grade 3 Malaise, Dose 2 |
|
|
| Related Malaise, Dose 2 |
|
|
| Any Myalgia, Dose 2 |
|
|
| Grade 3 Myalgia, Dose 2 |
|
|
| Related Myalgia, Dose 2 |
|
|
| Any Temperature/(Axillary), Dose 2 |
|
|
| Grade 3 Temperature/(Axillary), Dose 2 |
|
|
| Related Temperature/(Axillary), Dose 2 |
|
|
| Any Fatigue, Across doses |
|
|
| Grade 3 Fatigue, Across doses |
|
|
| Related Fatigue, Across doses |
|
|
| Any Gastrointestinal symptoms,Across doses |
|
|
| Grade 3 Gastrointestinal symptoms,Across doses |
|
|
| Related Gastrointestinal symptoms,Across doses |
|
|
| Any Headache, Across doses |
|
|
| Grade 3 Headache, Across doses |
|
|
| Related Headache, Across doses |
|
|
| Any Malaise, Across doses |
|
|
| Grade 3 Malaise, Across doses |
|
|
| Related Malaise, Across doses |
|
|
| Any Myalgia, Across doses |
|
|
| Grade 3 Myalgia, Across doses |
|
|
| Related Myalgia, Across doses |
|
|
| Any Temperature/(Axillary), Across doses |
|
|
| Grade 3 Temperature/(Axillary), Across doses |
|
|
| Related Temperature/(Axillary), Across doses |
|
|
|
| Anti-M72, Day 30 |
|
|
| Anti-M72, Day 60 |
|
|
| Anti-M72, Day 210 |
|
|
|
| Anti-M72, Day 30 |
|
|
| Anti-M72, Day 60 |
|
|
| Anti-M72, Day 210 |
|
|
|
| CD4-ALL doubles, Day 7 |
|
|
| CD4-ALL doubles, Day 30 |
|
|
| CD4-ALL doubles, Day 37 |
|
|
| CD4-ALL doubles, Day 60 |
|
|
| CD4-ALL doubles, Day 210 |
|
|
|
| CD4- At least 2, Day 7 |
|
|
| CD4- At least 2, Day 30 |
|
|
| CD4- At least 2, Day 37 |
|
|
| CD4- At least 2, Day 60 |
|
|
| CD4- At least 2, Day 210 |
|
|
|
| CD40L+/IL2+/TNFa+/IFNg+, Day 7 |
|
|
| CD40L+/IL2+/TNFa+/IFNg+, Day 30 |
|
|
| CD40L+/IL2+/TNFa+/IFNg+, Day 37 |
|
|
| CD40L+/IL2+/TNFa+/IFNg+, Day 60 |
|
|
| CD40L+/IL2+/TNFa+/IFNg+, Day 210 |
|
|
| CD40L+/IL2+/TNFa+/IFNg-, Day 0 |
|
|
| CD40L+/IL2+/TNFa+/IFNg-, Day 7 |
|
|
| CD40L+/IL2+/TNFa+/IFNg-, Day 30 |
|
|
| CD40L+/IL2+/TNFa+/IFNg-, Day 37 |
|
|
| CD40L+/IL2+/TNFa+/IFNg-, Day 60 |
|
|
| CD40L+/IL2+/TNFa+/IFNg-, Day 210 |
|
|
|
| CD40L+/IL2+/TNFa-/IFNg+, Day 7 |
|
|
| CD40L+/IL2+/TNFa-/IFNg+, Day 30 |
|
|
| CD40L+/IL2+/TNFa-/IFNg+, Day 37 |
|
|
| CD40L+/IL2+/TNFa-/IFNg+, Day 60 |
|
|
| CD40L+/IL2+/TNFa-/IFNg+, Day 210 |
|
|
| CD40L+/IL2+/TNFa-/IFNg-, Day 0 |
|
|
| CD40L+/IL2+/TNFa-/IFNg-, Day 7 |
|
|
| CD40L+/IL2+/TNFa-/IFNg-, Day 30 |
|
|
| CD40L+/IL2+/TNFa-/IFNg-, Day 37 |
|
|
| CD40L+/IL2+/TNFa-/IFNg-, Day 60 |
|
|
| CD40L+/IL2+/TNFa-/IFNg-, Day 210 |
|
|
|
| CD40L+/IL2-/TNFa+/IFNg+, Day 7 |
|
|
| CD40L+/IL2-/TNFa+/IFNg+, Day 30 |
|
|
| CD40L+/IL2-/TNFa+/IFNg+, Day 37 |
|
|
| CD40L+/IL2-/TNFa+/IFNg+, Day 60 |
|
|
| CD40L+/IL2-/TNFa+/IFNg+, Day 210 |
|
|
| CD40L+/IL2-/TNFa+/IFNg-, Day 0 |
|
|
| CD40L+/IL2-/TNFa+/IFNg-, Day 7 |
|
|
| CD40L+/IL2-/TNFa+/IFNg-, Day 30 |
|
|
| CD40L+/IL2-/TNFa+/IFNg-, Day 37 |
|
|
| CD40L+/IL2-/TNFa+/IFNg-, Day 60 |
|
|
| CD40L+/IL2-/TNFa+/IFNg-, Day 210 |
|
|
|
| CD40L+/IL2-/TNFa-/IFNg+, Day 7 |
|
|
| CD40L+/IL2-/TNFa-/IFNg+, Day 30 |
|
|
| CD40L+/IL2-/TNFa-/IFNg+, Day 37 |
|
|
| CD40L+/IL2-/TNFa-/IFNg+, Day 60 |
|
|
| CD40L+/IL2-/TNFa-/IFNg+, Day 210 |
|
|
| CD40L+/IL2-/TNFa-/IFNg-, Day 0 |
|
|
| CD40L+/IL2-/TNFa-/IFNg-, Day 7 |
|
|
| CD40L+/IL2-/TNFa-/IFNg-, Day 30 |
|
|
| CD40L+/IL2-/TNFa-/IFNg-, Day 37 |
|
|
| CD40L+/IL2-/TNFa-/IFNg-, Day 60 |
|
|
| CD40L+/IL2-/TNFa-/IFNg-, Day 210 |
|
|
|
| CD40L-/IL2+/TNFa+/IFNg+, Day 7 |
|
|
| CD40L-/IL2+/TNFa+/IFNg+, Day 30 |
|
|
| CD40L-/IL2+/TNFa+/IFNg+, Day 37 |
|
|
| CD40L-/IL2+/TNFa+/IFNg+, Day 60 |
|
|
| CD40L-/IL2+/TNFa+/IFNg+, Day 210 |
|
|
| CD40L-/IL2+/TNFa+/IFNg-, Day 0 |
|
|
| CD40L-/IL2+/TNFa+/IFNg-, Day 7 |
|
|
| CD40L-/IL2+/TNFa+/IFNg-, Day 30 |
|
|
| CD40L-/IL2+/TNFa+/IFNg-, Day 37 |
|
|
| CD40L-/IL2+/TNFa+/IFNg-, Day 60 |
|
|
| CD40L-/IL2+/TNFa+/IFNg-, Day 210 |
|
|
|
| CD40L-/IL2+/TNFa-/IFNg+, Day 7 |
|
|
| CD40L-/IL2+/TNFa-/IFNg+, Day 30 |
|
|
| CD40L-/IL2+/TNFa-/IFNg+, Day 37 |
|
|
| CD40L-/IL2+/TNFa-/IFNg+, Day 60 |
|
|
| CD40L-/IL2+/TNFa-/IFNg+, Day 210 |
|
|
| CD40L-/IL2+/TNFa-/IFNg-, Day 0 |
|
|
| CD40L-/IL2+/TNFa-/IFNg-, Day 7 |
|
|
| CD40L-/IL2+/TNFa-/IFNg-, Day 30 |
|
|
| CD40L-/IL2+/TNFa-/IFNg-, Day 37 |
|
|
| CD40L-/IL2+/TNFa-/IFNg-, Day 60 |
|
|
| CD40L-/IL2+/TNFa-/IFNg-, Day 210 |
|
|
|
| CD40L-/IL2-/TNFa+/IFNg+, Day 7 |
|
|
| CD40L-/IL2-/TNFa+/IFNg+, Day 30 |
|
|
| CD40L-/IL2-/TNFa+/IFNg+, Day 37 |
|
|
| CD40L-/IL2-/TNFa+/IFNg+, Day 60 |
|
|
| CD40L-/IL2-/TNFa+/IFNg+, Day 210 |
|
|
| CD40L-/IL2-/TNFa+/IFNg-, Day 0 |
|
|
| CD40L-/IL2-/TNFa+/IFNg-, Day 7 |
|
|
| CD40L-/IL2-/TNFa+/IFNg-, Day 30 |
|
|
| CD40L-/IL2-/TNFa+/IFNg-, Day 37 |
|
|
| CD40L-/IL2-/TNFa+/IFNg-, Day 60 |
|
|
| CD40L-/IL2-/TNFa+/IFNg-, Day 210 |
|
|
|
| CD40L-/IL2-/TNFa-/IFNg+, Day 7 |
|
|
| CD40L-/IL2-/TNFa-/IFNg+, Day 30 |
|
|
| CD40L-/IL2-/TNFa-/IFNg+, Day 37 |
|
|
| CD40L-/IL2-/TNFa-/IFNg+, Day 60 |
|
|
| CD40L-/IL2-/TNFa-/IFNg+, Day 210 |
|
|
|
| CD8-All Doubles, Day 7 |
|
|
| CD8-All Doubles, Day 30 |
|
|
| CD8-All Doubles, Day 37 |
|
|
| CD8-All Doubles, Day 60 |
|
|
| CD8-All Doubles, Day 210 |
|
|
|
| CD8- At least 2, Day 7 |
|
|
| CD8- At least 2, Day 30 |
|
|
| CD8- At least 2, Day 37 |
|
|
| CD8- At least 2, Day 60 |
|
|
| CD8- At least 2, Day 210 |
|
|
|
| CD40L+/IL2+/TNFa+/IFNg+, Day 7 |
|
|
| CD40L+/IL2+/TNFa+/IFNg+, Day 30 |
|
|
| CD40L+/IL2+/TNFa+/IFNg+, Day 37 |
|
|
| CD40L+/IL2+/TNFa+/IFNg+, Day 60 |
|
|
| CD40L+/IL2+/TNFa+/IFNg+, Day 210 |
|
|
| CD40L+/IL2+/TNFa+/IFNg-, Day 0 |
|
|
| CD40L+/IL2+/TNFa+/IFNg-, Day 7 |
|
|
| CD40L+/IL2+/TNFa+/IFNg-, Day 30 |
|
|
| CD40L+/IL2+/TNFa+/IFNg-, Day 37 |
|
|
| CD40L+/IL2+/TNFa+/IFNg-, Day 60 |
|
|
| CD40L+/IL2+/TNFa+/IFNg-, Day 210 |
|
|
|
| CD40L+/IL2+/TNFa-/IFNg+, Day 7 |
|
|
| CD40L+/IL2+/TNFa-/IFNg+, Day 30 |
|
|
| CD40L+/IL2+/TNFa-/IFNg+, Day 37 |
|
|
| CD40L+/IL2+/TNFa-/IFNg+, Day 60 |
|
|
| CD40L+/IL2+/TNFa-/IFNg+, Day 210 |
|
|
| CD40L+/IL2+/TNFa-/IFNg-, Day 0 |
|
|
| CD40L+/IL2+/TNFa-/IFNg-, Day 7 |
|
|
| CD40L+/IL2+/TNFa-/IFNg-, Day 30 |
|
|
| CD40L+/IL2+/TNFa-/IFNg-, Day 37 |
|
|
| CD40L+/IL2+/TNFa-/IFNg-, Day 60 |
|
|
| CD40L+/IL2+/TNFa-/IFNg-, Day 210 |
|
|
|
| CD40L+/IL2-/TNFa+/IFNg+, Day 7 |
|
|
| CD40L+/IL2-/TNFa+/IFNg+, Day 30 |
|
|
| CD40L+/IL2-/TNFa+/IFNg+, Day 37 |
|
|
| CD40L+/IL2-/TNFa+/IFNg+, Day 60 |
|
|
| CD40L+/IL2-/TNFa+/IFNg+, Day 210 |
|
|
| CD40L+/IL2-/TNFa+/IFNg-, Day 0 |
|
|
| CD40L+/IL2-/TNFa+/IFNg-, Day 7 |
|
|
| CD40L+/IL2-/TNFa+/IFNg-, Day 30 |
|
|
| CD40L+/IL2-/TNFa+/IFNg-, Day 37 |
|
|
| CD40L+/IL2-/TNFa+/IFNg-, Day 60 |
|
|
| CD40L+/IL2-/TNFa+/IFNg-, Day 210 |
|
|
|
| CD40L+/IL2-/TNFa-/IFNg+, Day 7 |
|
|
| CD40L+/IL2-/TNFa-/IFNg+, Day 30 |
|
|
| CD40L+/IL2-/TNFa-/IFNg+, Day 37 |
|
|
| CD40L+/IL2-/TNFa-/IFNg+, Day 60 |
|
|
| CD40L+/IL2-/TNFa-/IFNg+, Day 210 |
|
|
| CD40L+/IL2-/TNFa-/IFNg-, Day 0 |
|
|
| CD40L+/IL2-/TNFa-/IFNg-, Day 7 |
|
|
| CD40L+/IL2-/TNFa-/IFNg-, Day 30 |
|
|
| CD40L+/IL2-/TNFa-/IFNg-, Day 37 |
|
|
| CD40L+/IL2-/TNFa-/IFNg-, Day 60 |
|
|
| CD40L+/IL2-/TNFa-/IFNg-, Day 210 |
|
|
|
| CD40L-/IL2+/TNFa+/IFNg+, Day 7 |
|
|
| CD40L-/IL2+/TNFa+/IFNg+, Day 30 |
|
|
| CD40L-/IL2+/TNFa+/IFNg+, Day 37 |
|
|
| CD40L-/IL2+/TNFa+/IFNg+, Day 60 |
|
|
| CD40L-/IL2+/TNFa+/IFNg+, Day 210 |
|
|
| CD40L-/IL2+/TNFa+/IFNg-, Day 0 |
|
|
| CD40L-/IL2+/TNFa+/IFNg-, Day 7 |
|
|
| CD40L-/IL2+/TNFa+/IFNg-, Day 30 |
|
|
| CD40L-/IL2+/TNFa+/IFNg-, Day 37 |
|
|
| CD40L-/IL2+/TNFa+/IFNg-, Day 60 |
|
|
| CD40L-/IL2+/TNFa+/IFNg-, Day 210 |
|
|
|
| CD40L-/IL2+/TNFa-/IFNg+, Day 7 |
|
|
| CD40L-/IL2+/TNFa-/IFNg+, Day 30 |
|
|
| CD40L-/IL2+/TNFa-/IFNg+, Day 37 |
|
|
| CD40L-/IL2+/TNFa-/IFNg+, Day 60 |
|
|
| CD40L-/IL2+/TNFa-/IFNg+, Day 210 |
|
|
| CD40L-/IL2+/TNFa-/IFNg-, Day 0 |
|
|
| CD40L-/IL2+/TNFa-/IFNg-, Day 7 |
|
|
| CD40L-/IL2+/TNFa-/IFNg-, Day 30 |
|
|
| CD40L-/IL2+/TNFa-/IFNg-, Day 37 |
|
|
| CD40L-/IL2+/TNFa-/IFNg-, Day 60 |
|
|
| CD40L-/IL2+/TNFa-/IFNg-, Day 210 |
|
|
|
| CD40L-/IL2-/TNFa+/IFNg+, Day 7 |
|
|
| CD40L-/IL2-/TNFa+/IFNg+, Day 30 |
|
|
| CD40L-/IL2-/TNFa+/IFNg+, Day 37 |
|
|
| CD40L-/IL2-/TNFa+/IFNg+, Day 60 |
|
|
| CD40L-/IL2-/TNFa+/IFNg+, Day 210 |
|
|
| CD40L-/IL2-/TNFa+/IFNg-, Day 0 |
|
|
| CD40L-/IL2-/TNFa+/IFNg-, Day 7 |
|
|
| CD40L-/IL2-/TNFa+/IFNg-, Day 30 |
|
|
| CD40L-/IL2-/TNFa+/IFNg-, Day 37 |
|
|
| CD40L-/IL2-/TNFa+/IFNg-, Day 60 |
|
|
| CD40L-/IL2-/TNFa+/IFNg-, Day 210 |
|
|
|
| CD40L-/IL2-/TNFa-/IFNg+, Day 7 |
|
|
| CD40L-/IL2-/TNFa-/IFNg+, Day 30 |
|
|
| CD40L-/IL2-/TNFa-/IFNg+, Day 37 |
|
|
| CD40L-/IL2-/TNFa-/IFNg+, Day 60 |
|
|
| CD40L-/IL2-/TNFa-/IFNg+, Day 210 |
|
|