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CompletedNCT00621322Updated Aug 24, 2018Results posted

Safety and Immunogenicity Study of GSK Biologicals Tuberculosis Vaccines (692342) to Healthy Adults

A Phase 2 interventional study of GSK Biologicals' AS01B adjuvant and GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1 in Tuberculosis, sponsored by GlaxoSmithKline. Completed at 1 site in Philippines. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-24.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This observer blind study will assess the safety and immunogenicity of different formulations of GSK Biologicals' 692342 tuberculosis vaccine in healthy adults aged 18 to 45 years with a positive PPD skin test. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

02

Conditions studied

  • Tuberculosis

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Keywords

  • Tuberculosis vaccine
03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 180 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including, 18 and 45 years of age at the time of the first vaccination.
  • Written informed consent obtained from the subject prior to any study procedure.
  • Free of obvious health problems as established by medical history and clinical examination before enrolment into the study.
  • If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
  • No evidence of pulmonary pathology as confirmed by chest X-ray.
  • No history of extrapulmonary TB.
  • Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), complete blood count (CBC) and urinalysis.
  • Seronegative for human immunodeficiency virus-1 and -2 (HIV-1 and -2) antibodies.
  • Subjects must have a PPD positive skin reactivity 48 to 72 hours after PPD skin test administration.

Exclusion criteria

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • 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, with the exception of vitamins and/or dietary supplements, herbal medications, birth control pills, anti-histamines for seasonal allergies and SSRIs.
  • History of previous administration of experimental Mycobacterium tuberculosis vaccines.
  • History of previous exposure to experimental products containing MPL or QS21.
  • Administration of any immunoglobulins, any immunotherapy and/or any blood products within the three months preceding the first dose of study vaccination, or planned administrations during the study period.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • A family history (first generation) of congenital or hereditary immunodeficiency.
  • History of any acute or chronic illness or medication that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
  • History of any neurological disorders or seizures.
  • History of allergic reactions or anaphylaxis to previous immunisations.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • History of chronic alcohol consumption and/or drug abuse.
  • Major congenital defects.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
180 participants (actual)

Study arms

  • Placebo comparator
    Control Group

    Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals' AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.

    Biological: GSK Biologicals' AS01B adjuvant

  • Active comparator
    GSK692342_F1 Group

    Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.

    Biological: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1

  • Experimental
    GSK692342_F2 Group

    Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.

    Biological: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2

  • Experimental
    GSK692342_F3 Group

    Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.

    Biological: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 3

  • Experimental
    GSK692342_F4D1 Group

    Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.

    Biological: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 1

  • Experimental
    GSK692342_F4D2 Group

    Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.

    Biological: GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 2

Interventions

  • BiologicalGSK Biologicals' AS01B adjuvant

    Intramuscular injection, 2 doses

  • BiologicalGSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1

    Intramuscular injection, 2 doses

  • BiologicalGSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2

    Intramuscular injection, 2 doses

  • BiologicalGSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 3

    Intramuscular injection, 2 doses

  • BiologicalGSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 1

    Intramuscular injection, 2 doses

  • BiologicalGSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 2

    Intramuscular injection, 2 doses

06

What researchers measure

Primary outcomes

  1. Number of Subjects With Solicited Local Symptoms

    Assessed solicited local symptoms included pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.

    Time frame: During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses

  2. Number of Subjects With Solicited General Symptoms

    Assessed solicited general symptoms included fatigue, temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal symptoms (gastro) \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

    Time frame: During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses

  3. Number of Subjects With Unsolicited 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

    Time frame: During the 30-day (Days 0-29) post-vaccination period

  4. 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.

    Time frame: During the entire study period (from Day 0 up to Day 210)

  5. Number of Subjects With Different Biochemical and Haematological Levels

    Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.

    Time frame: At Day 0

  6. Number of Subjects With Different Biochemical and Haematological Levels

    Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.

    Time frame: At Day 7

  7. Number of Subjects With Different Biochemical and Haematological Levels

    Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.

    Time frame: At Day 30

  8. Number of Subjects With Different Biochemical and Haematological Levels

    Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.

    Time frame: At Day 37

  9. Number of Subjects With Different Biochemical and Haematological Levels

    Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.

    Time frame: At Day 60

Secondary outcomes

  1. Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines

    Among cytokines expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).

    Time frame: At Day 0, 30, 60 and 210

  2. Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule

    Expressed cytokine combinations for CD4+ T cells were CD40-L and IL-2 or IFN-γ or TNF-α; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ. For CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines.

    Time frame: At Day 0, 30, 60 and 210

  3. Anti-M72 Specific Antibody Concentrations

    Concentrations given in enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) were expressed as geometric mean concentrations (GMCs).

    Time frame: At Day 0, 30, 60 and 210

07

Results

Posted Feb 3, 2017

Participant flow

Participant flow — Overall Study
MilestoneControl GroupGSK692342_F1 GroupGSK692342_F2 GroupGSK692342_F3 GroupGSK692342_F4D1 GroupGSK692342_F4D2 Group
Started101040404040
Completed91038373936
Not completed102314
Withdrew: Lost to follow-up000010
Withdrew: Physician decision001100
Withdrew: Withdrawal by subject000102
Withdrew: Migrated/moved from study area101102

Outcome measures

PrimaryNumber of Subjects With Solicited Local Symptoms

Assessed solicited local symptoms included pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.

Time frame:
During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses
Reported as:
Number · Subjects
Number of Subjects With Solicited Local Symptoms
SubjectsControl GroupGSK692342_F1 GroupGSK692342_F2 GroupGSK692342_F3 GroupGSK692342_F4D1 GroupGSK692342_F4D2 Group
Any Pain, Dose 18335333332
Grade 3 Pain, Dose 1000001
Any Redness, Dose 1127343
Grade 3 Redness, Dose 1000000
Any Swelling, Dose 1008676
Grade 3 Swelling, Dose 1000001
Any Pain, Dose 27433323633
Grade 3 Pain, Dose 2000001
Any Redness, Dose 2010545
Grade 3 Redness, Dose 2000011
Any Swelling, Dose 2115578
Grade 3 Swelling, Dose 2000111
Any Pain, Across9538373736
Grade 3 Pain, Across000002
Any Redness, Across127666
Grade 3 Redness, Across000011
Any Swelling, Across1110101212
Grade 3 Swelling, Across000112
PrimaryNumber of Subjects With Solicited General Symptoms

Assessed solicited general symptoms included fatigue, temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal symptoms (gastro) \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Time frame:
During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses
Reported as:
Number · Subjects
Number of Subjects With Solicited General Symptoms
SubjectsControl GroupGSK692342_F1 GroupGSK692342_F2 GroupGSK692342_F3 GroupGSK692342_F4D1 GroupGSK692342_F4D2 Group
Any Fatigue, Dose 1114573
Grade 3 Fatigue, Dose 1000000
Related Fatigue, Dose 1001342
Any Gastro, Dose 1235357
Grade 3 Gastro, Dose 1000000
Related Gastro, Dose 1203112
Any Headache, Dose 14411161519
Grade 3 Headache, Dose 1110000
Related Headache, Dose 12078710
Any Malaise, Dose 1339131018
Grade 3 Malaise, Dose 1000000
Related Malaise, Dose 12078816
Any Myalgia, Dose 11314101314
Grade 3 Myalgia, Dose 1000000
Related Myalgia, Dose 111961113
Any Temperature, Dose 1213239
Grade 3 Temperature, Dose 1000002
Related Temperature, Dose 1103128
Any Fatigue, Dose 2115688
Grade 3 Fatigue, Dose 2000000
Related Fatigue, Dose 2114367
Any Gastro, Dose 2115789
Grade 3 Gastro, Dose 2000010
Related Gastro, Dose 2001178
Any Headache, Dose 25322202926
Grade 3 Headache, Dose 2001011
Related Headache, Dose 2111382422
Any Malaise, Dose 25122212125
Grade 3 Malaise, Dose 2001001
Related Malaise, Dose 24121172124
Any Myalgia, Dose 23118212328
Grade 3 Myalgia, Dose 2001021
Related Myalgia, Dose 22118202328
Any Temperature, Dose 2301581627
Grade 3 Temperature, Dose 2002013
Related Temperature, Dose 2201371527
Any Fatigue, Across21781310
Grade 3 Fatigue, Across000000
Related Fatigue, Across114698
Any Gastro, Across33891110
Grade 3 Gastro, Across000010
Related Gastro, Across204288
Any Headache, Across5625273026
Grade 3 Headache, Across111011
Related Headache, Across3118152423
Any Malaise, Across5323252326
Grade 3 Malaise, Across001001
Related Malaise, Across5122212326
Any Myalgia, Across3325232429
Grade 3 Myalgia, Across001021
Related Myalgia, Across2224222429
Any Temperature, Across511791728
Grade 3 Temperature, Across002014
Related Temperature, Across301571528
PrimaryNumber of Subjects With Unsolicited 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Time frame:
During the 30-day (Days 0-29) post-vaccination period
Reported as:
Number · Subjects
Number of Subjects With Unsolicited Adverse Events (AEs)
SubjectsControl GroupGSK692342_F1 GroupGSK692342_F2 GroupGSK692342_F3 GroupGSK692342_F4D1 GroupGSK692342_F4D2 Group
Any AEs7929333327
Grade 3 AEs001100
Related AEs017252
PrimaryNumber 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.

Time frame:
During the entire study period (from Day 0 up to Day 210)
Reported as:
Number · Subjects
Number of Subjects With Serious Adverse Events (SAEs)
SubjectsControl GroupGSK692342_F1 GroupGSK692342_F2 GroupGSK692342_F3 GroupGSK692342_F4D1 GroupGSK692342_F4D2 Group
Number of Subjects With Serious Adverse Events (SAEs)002020
PrimaryNumber of Subjects With Different Biochemical and Haematological Levels

Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.

Time frame:
At Day 0
Reported as:
Number · Subjects
Number of Subjects With Different Biochemical and Haematological Levels
SubjectsControl GroupGSK692342_F1 GroupGSK692342_F2 GroupGSK692342_F3 GroupGSK692342_F4D1 GroupGSK692342_F4D2 Group
ALT, Normal101040383837
ALT, Below000000
ALT, Above000123
ALT, Missing000100
AST, Normal9940383738
AST, Below000000
AST, Above110132
AST, Missing000100
BAS, Normal31011184039
BAS, Below000000
BAS, Above000000
BAS, Missing70292201
CREA, Normal91038383939
CREA, Below102111
CREA, Above000000
CREA, Missing000100
EOS, Normal9838383334
EOS, Below001100
EOS, Above120175
EOS, Missing001001
Hct, Normal10938393735
Hct, Below011134
Hct, Above000000
Hct, Missing001001
Hgb, Normal10839393836
Hgb, Below020123
Hgb, Above000000
Hgb, Missing001001
LYM, Normal91038373937
LYM, Below101312
LYM, Above000000
LYM, Missing001001
MON, Normal10939403838
MON, Below010021
MON, Above000000
MON, Missing001001
NEU, Normal91035363736
NEU, Below000000
NEU, Above104433
NEU, Missing001001
PLA, Normal101039404039
PLA, Below000000
PLA, Above000000
PLA, Missing001001
RBC, Normal9736353635
RBC, Below112124
RBC, Above021420
RBC, Missing001001
WBC, Normal10937313036
WBC, Below000010
WBC, Above012993
WBC, Missing001001
PrimaryNumber of Subjects With Different Biochemical and Haematological Levels

Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.

Time frame:
At Day 7
Reported as:
Number · Subjects
Number of Subjects With Different Biochemical and Haematological Levels
SubjectsControl GroupGSK692342_F1 GroupGSK692342_F2 GroupGSK692342_F3 GroupGSK692342_F4D1 GroupGSK692342_F4D2 Group
ALT, Normal101036323834
ALT, Below001001
ALT, Above002724
ALT, Missing000100
AST, Normal101039364037
AST, Below000000
AST, Above000302
AST, Missing001111
BAS, Normal210174039
BAS, Below000000
BAS, Above000000
BAS, Missing80393301
CREA, Normal101038363939
CREA, Below000010
CREA, Above001300
CREA, Missing001101
EOS, Normal10638383231
EOS, Below000000
EOS, Above041288
EOS, Missing001001
Hct, Normal10837373433
Hct, Below022366
Hct, Above000000
Hct, Missing001001
Hgb, Normal10739383336
Hgb, Below030273
Hgb, Above000000
Hgb, Missing001001
LYM, Normal101038404038
LYM, Below001001
LYM, Above000000
LYM, Missing001001
MON, Normal10939403839
MON, Below010020
MON, Above000000
MON, Missing001001
NEU, Normal91038404038
NEU, Below000000
NEU, Above101001
NEU, Missing001001
PLA, Normal10939403939
PLA, Below000000
PLA, Above010010
PLA, Missing001001
RBC, Normal8833333433
RBC, Below215556
RBC, Above011210
RBC, Missing001001
WBC, Normal9933373135
WBC, Below000020
WBC, Above116374
WBC, Missing001001
PrimaryNumber of Subjects With Different Biochemical and Haematological Levels

Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.

Time frame:
At Day 30
Reported as:
Number · Subjects
Number of Subjects With Different Biochemical and Haematological Levels
SubjectsControl GroupGSK692342_F1 GroupGSK692342_F2 GroupGSK692342_F3 GroupGSK692342_F4D1 GroupGSK692342_F4D2 Group
ALT, Normal9938363638
ALT, Below000010
ALT, Above111231
ALT, Missing001201
AST, Normal101038353737
AST, Below000000
AST, Above001332
AST, Missing001201
BAS, Normal4105133939
BAS, Below000000
BAS, Above000000
BAS, Missing60352711
CREA, Normal10939373637
CREA, Below000030
CREA, Above010112
CREA, Missing001201
EOS, Normal8837352830
EOS, Below001000
EOS, Above1215119
EOS, Missing101011
Hct, Normal8736343435
Hct, Below133554
Hct, Above000100
Hct, Missing101011
Hgb, Normal8738353336
Hgb, Below131463
Hgb, Above000100
Hgb, Missing101011
LYM, Normal9938403936
LYM, Below011003
LYM, Above000000
LYM, Missing101011
MON, Normal91039403939
MON, Below000000
MON, Above000000
MON, Missing101011
NEU, Normal91038393839
NEU, Below000000
NEU, Above001110
NEU, Missing101011
PLA, Normal91039403839
PLA, Below000010
PLA, Above000000
PLA, Missing101011
RBC, Normal9836363636
RBC, Below012223
RBC, Above011210
RBC, Missing101011
WBC, Normal9835373336
WBC, Below000030
WBC, Above024333
WBC, Missing101011
PrimaryNumber of Subjects With Different Biochemical and Haematological Levels

Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.

Time frame:
At Day 37
Reported as:
Number · Subjects
Number of Subjects With Different Biochemical and Haematological Levels
SubjectsControl GroupGSK692342_F1 GroupGSK692342_F2 GroupGSK692342_F3 GroupGSK692342_F4D1 GroupGSK692342_F4D2 Group
ALT, Normal91037363435
ALT, Below000000
ALT, Above102364
ALT, Missing001101
AST, Normal101037383736
AST, Below000000
AST, Above002133
AST, Missing001111
BAS, Normal41010154039
BAS, Below000000
BAS, Above000000
BAS, Missing6002501
CREA, Normal10938393839
CREA, Above000020
CREA, Below011000
CREA, Missing001101
EOS, Normal6735363333
EOS, Below001000
EOS, Above433376
EOS, Missing001101
Hct, Normal8734323535
Hct, Below235654
Hct, Above000100
Hct, Missing001101
Hgb, Normal9636343636
Hgb, Below143443
Hgb, Above000100
Hgb, Missing001101
LYM, Normal101038383939
LYM, Below001010
LYM, Above000100
LYM, Missing001101
MON, Normal101039383939
MON, Below000010
MON, Above000100
MON, Missing001101
NEU, Normal101038383937
NEU, Below000101
NEU, Above001011
NEU, Missing001101
PLA, Normal10937394039
PLA, Below000000
PLA, Above012000
PLA, Missing001101
RBC, Normal9834353633
RBC, Below115236
RBC, Above010210
RBC, Missing001101
WBC, Normal9732353334
WBC, Below000100
WBC, Above137375
WBC, Missing001101
PrimaryNumber of Subjects With Different Biochemical and Haematological Levels

Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[Hct\], haemoglobin \[Hgb\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.

Time frame:
At Day 60
Reported as:
Number · Subjects
Number of Subjects With Different Biochemical and Haematological Levels
SubjectsControl GroupGSK692342_F1 GroupGSK692342_F2 GroupGSK692342_F3 GroupGSK692342_F4D1 GroupGSK692342_F4D2 Group
ALT, Normal9938373834
ALT, Below000000
ALT, Above111225
ALT, Missing001101
AST, Normal9938373837
AST, Below000000
AST, Above111222
AST, Missing001101
BAS, Normal101038394039
BAS, Below000000
BAS, Above000000
BAS, Missing002101
CREA, Normal10938373939
CREA, Below011210
CREA, Above000000
CREA, Missing001101
EOS, Normal7734363231
EOS, Below000000
EOS, Above334388
EOS, Missing002101
Hct, Normal9833363636
Hct, Below125243
Hct, Above000100
Hct, Missing002101
Hgb, Normal9835363736
Hgb, Below123233
Hgb, Above000100
Hgb, Missing002101
LYM, Normal10838393837
LYM, Below020022
LYM, Above000000
LYM, Missing002101
MON, Normal10937394039
MON, Below011000
MON, Above000000
MON, Missing002101
NEU, Normal9838393737
NEU, Below000000
NEU, Above120032
NEU, Missing002101
PLA, Normal10938384039
PLA, Below000000
PLA, Above010100
PLA, Missing002101
RBC, Normal9836353736
RBC, Below112323
RBC, Above010110
RBC, Missing002101
WBC, Normal8734373631
WBC, Below000011
WBC, Above234237
WBC, Missing002101
SecondaryFrequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines

Among cytokines expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).

Time frame:
At Day 0, 30, 60 and 210
Reported as:
Median · T cells/million cells
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines
T cells/million cellsControl GroupGSK692342_F1 GroupGSK692342_F2 GroupGSK692342_F3 GroupGSK692342_F4D1 GroupGSK692342_F4D2 Group
CD4-All Doubles, D0 [N=9;9;38;34;40;39]173.0 (94.0 to 466.0)293.0 (213.0 to 853.0)200.0 (87.0 to 537.0)241.0 (147.0 to 547.0)263.5 (80.5 to 528.5)312.0 (133.0 to 488.0)
CD4-All Doubles, D30 [N=10;10;38;36;39;37]245.5 (80.0 to 387.0)1013.5 (491.0 to 3227.0)2833.0 (1440.0 to 5120.0)1653.5 (886.5 to 3587.0)2653.0 (1480.0 to 4826.0)3280.0 (2267.0 to 6928.0)
CD4-All Doubles, D60 [N=10;9;38;36;38;37]139.5 (27.0 to 187.0)2133.0 (640.0 to 3240.0)6307.0 (3560.0 to 9307.0)3855.5 (2353.5 to 5220.0)4880.0 (3147.0 to 6853.0)5133.0 (3227.0 to 7733.0)
CD4-All Doubles, D210 [N=9;7;37;32;35;34]106.0 (91.0 to 414.0)1426.0 (949.0 to 2814.0)3826.0 (2467.0 to 5907.0)2486.5 (1660.0 to 4075.0)3240.0 (2520.0 to 5360.0)3633.5 (2733.0 to 5253.0)
CD8-All Doubles, D0 [N=9;9;38;34;40;39]1.0 (1.0 to 65.0)5.0 (1.0 to 35.0)17.0 (1.0 to 104.0)33.0 (1.0 to 85.0)9.0 (1.0 to 91.0)18.0 (1.0 to 79.0)
CD8-All Doubles, D30 [N=10;10;38;36;39;37]31.0 (1.0 to 46.0)20.5 (1.0 to 146.0)39.5 (1.0 to 102.0)14.0 (1.0 to 77.5)26.0 (1.0 to 287.0)34.0 (1.0 to 90.0)
CD8-All Doubles, D60 [N=10;9;38;36;38;37]9.5 (1.0 to 175.0)16.0 (1.0 to 33.0)1.0 (1.0 to 71.0)10.0 (1.0 to 86.5)59.0 (1.0 to 167.0)16.0 (1.0 to 107.0)
CD8-All Doubles, D210 [N=9;7;37;32;35;34]1.0 (1.0 to 179.0)1.0 (1.0 to 28.0)1.0 (1.0 to 35.0)1.0 (1.0 to 84.0)54.0 (2.0 to 124.0)24.5 (1.0 to 46.0)
SecondaryFrequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule

Expressed cytokine combinations for CD4+ T cells were CD40-L and IL-2 or IFN-γ or TNF-α; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ. For CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines.

Time frame:
At Day 0, 30, 60 and 210
Reported as:
Median · T cells/million cells
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule
T cells/million cellsControl GroupGSK692342_F1 GroupGSK692342_F2 GroupGSK692342_F3 GroupGSK692342_F4D1 GroupGSK692342_F4D2 Group
CD4-CD40-L, D0 [N=9;9;38;34;40;39]104.0 (66.0 to 306.0)227.0 (186.0 to 840.0)147.0 (41.0 to 254.0)151.0 (107.0 to 320.0)210.5 (73.0 to 388.0)261.0 (94.0 to 418.0)
CD4-CD40-L, D30 [N=10;10;38;36;39;37]188.0 (40.0 to 307.0)853.0 (427.0 to 3133.0)1934.0 (1333.0 to 3600.0)1280.0 (833.5 to 2219.5)2334.0 (1387.0 to 3700.0)3213.0 (1853.0 to 6801.0)
CD4-CD40-L, D60 [N=10;9;38;36;38;37]87.0 (1.0 to 227.0)1986.0 (560.0 to 3173.0)5413.5 (2535.0 to 7235.0)2813.5 (1740.0 to 4293.5)4384.5 (2826.0 to 5813.0)4680.0 (3120.0 to 6547.0)
CD4-CD40-L, D210 [N=9;7;37;32;35;34]120.0 (80.0 to 380.0)1374.0 (920.0 to 2693.0)3727.0 (2431.0 to 5733.0)2424.5 (1586.5 to 3744.0)3173.0 (2333.0 to 5307.0)3540.0 (2486.0 to 5025.0)
CD40-IL-2, D0 [N=9;9;38;34;40;39]146.0 (93.0 to 467.0)333.0 (207.0 to 787.0)173.0 (66.0 to 373.0)224.0 (80.0 to 477.0)202.5 (73.5 to 413.0)226.0 (67.0 to 360.0)
CD4-IL-2, D30 [N=10;10;38;36;39;37]218.5 (40.0 to 320.0)1046.5 (453.0 to 2356.0)2560.0 (1426.0 to 4680.0)1460.0 (827.0 to 3093.5)2520.0 (1147.0 to 4186.0)3120.0 (1806.0 to 6546.0)
CD4-IL-2, D60 [N=10;9;38;36;38;37]107.0 (34.0 to 200.0)1773.0 (533.0 to 2840.0)5704.0 (3284.0 to 7947.0)3068.5 (2055.5 to 4473.0)4460.0 (2762.0 to 5591.0)4414.0 (2894.0 to 7027.0)
CD4-IL-2, D210 [N=9;7;37;32;35;34]114.0 (66.0 to 312.0)1427.0 (840.0 to 2227.0)3240.0 (2360.0 to 5813.0)2180.0 (1526.5 to 3569.5)3080.0 (2293.0 to 5226.0)3533.5 (2400.0 to 5037.0)
CD40-TNF-α, D0 [N=9;9;38;34;40;39]78.0 (53.0 to 334.0)220.0 (146.0 to 640.0)143.5 (67.0 to 493.0)180.5 (79.0 to 449.0)177.5 (56.0 to 398.0)160.0 (29.0 to 293.0)
CD4-TNF-α, D30 [N=10;10;38;36;39;37]185.5 (93.0 to 346.0)733.5 (345.0 to 2360.0)2028.0 (1013.0 to 4080.0)1140.0 (473.5 to 3026.5)1534.0 (867.0 to 3813.0)2133.0 (867.0 to 4480.0)
CD4-TNF-α, D60 [N=10;9;38;36;38;37]73.0 (1.0 to 226.0)907.0 (427.0 to 1373.0)3993.5 (1788.0 to 7223.0)2086.5 (1306.5 to 3754.0)3019.5 (1790.0 to 3776.0)2867.0 (1510.0 to 4200.0)
CD4-TNF-α, D210 [N=9;7;37;32;35;34]72.0 (1.0 to 379.0)1106.0 (718.0 to 2307.0)2960.0 (1613.0 to 4987.0)1831.0 (1086.0 to 3096.0)2305.0 (1694.0 to 4133.0)2580.0 (1840.0 to 4240.0)
CD40-IFN-γ, D0 [N=9;9;38;34;40;39]134.0 (13.0 to 480.0)258.0 (214.0 to 840.0)180.5 (67.0 to 471.0)193.5 (69.0 to 435.0)233.5 (67.0 to 493.5)306.0 (146.0 to 483.0)
CD4-IFN-γ, D30 [N=10;10;38;36;39;37]206.5 (54.0 to 279.0)626.5 (333.0 to 2306.0)1477.0 (496.0 to 3675.0)938.5 (347.5 to 2500.0)1097.0 (654.0 to 3440.0)1733.0 (698.0 to 4688.0)
CD4-IFN-γ, D60 [N=10;9;38;36;38;37]111.0 (40.0 to 266.0)1014.0 (320.0 to 1480.0)3070.5 (1134.0 to 4794.0)1233.0 (667.0 to 2946.5)2016.0 (1253.0 to 3010.0)2453.0 (1320.0 to 3853.0)
CD4-IFN-γ, D210 [N=9;7;37;32;35;34]146.0 (107.0 to 360.0)933.0 (336.0 to 1826.0)1907.0 (827.0 to 3413.0)927.0 (483.5 to 1823.5)1413.0 (915.0 to 2054.0)1711.0 (892.0 to 2310.0)
SecondaryAnti-M72 Specific Antibody Concentrations

Concentrations given in enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) were expressed as geometric mean concentrations (GMCs).

Time frame:
At Day 0, 30, 60 and 210
Reported as:
Geometric mean · EL.U/mL
Anti-M72 Specific Antibody Concentrations
EL.U/mLControl GroupGSK692342_F1 GroupGSK692342_F2 GroupGSK692342_F3 GroupGSK692342_F4D1 GroupGSK692342_F4D2 Group
Anti-M72, D0 [N=10;10;39;38;40;39]1.4 (1.4 to 1.4)1.4 (1.4 to 1.4)1.4 (1.4 to 1.4)1.4 (1.4 to 1.4)1.4 (1.4 to 1.4)1.4 (1.4 to 1.4)
Anti-M72, D30 [N=10;10;39;38;40;39]1.4 (1.4 to 1.4)2.9 (1.4 to 6.0)4.9 (3.5 to 6.9)5.5 (4.1 to 7.4)8.7 (6.5 to 11.7)15.0 (11.2 to 20.0)
Anti-M72, D60 [N=10;10;39;38;40;39]1.4 (1.4 to 1.4)31.0 (7.3 to 132.0)458.4 (365.2 to 575.4)468.5 (367.0 to 598.0)598.6 (504.0 to 710.9)833.0 (696.2 to 996.7)
Anti-M72, D210 [N=9;10;38;36;39;36]1.4 (1.4 to 1.4)6.1 (2.1 to 17.8)51.1 (37.5 to 69.8)46.3 (37.2 to 57.6)70.7 (57.5 to 87.0)85.2 (71.3 to 101.9)

Adverse events

Collected over Solicited local/general symptoms during the 7-day (Days 0-6) post-vaccination period; AEs during the 30-day (Days 0-29) post-vaccination period; SAEs up to Day 210. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control Group—0/10 (0%)10/10 (100%)
GSK692342_F1 Group—0/10 (0%)9/10 (90%)
GSK692342_F2 Group—2/40 (5%)40/40 (100%)
GSK692342_F3 Group—0/40 (0%)39/40 (97.5%)
GSK692342_F4D1 Group—2/40 (5%)39/40 (97.5%)
GSK692342_F4D2 Group—0/40 (0%)38/40 (95%)
Most frequent serious events
Most frequent serious events
EventControl GroupGSK692342_F1 GroupGSK692342_F2 GroupGSK692342_F3 GroupGSK692342_F4D1 GroupGSK692342_F4D2 Group
AsthmaRespiratory, thoracic and mediastinal disorders0/100/101/400/400/400/40
Dengue feverInfections and infestations0/100/101/400/400/400/40
Pyelonephritis acuteInfections and infestations0/100/100/400/401/400/40
Typhoid feverInfections and infestations0/100/101/400/400/400/40
Food poisoningGastrointestinal disorders0/100/100/400/401/400/40
Type 2 diabetes mellitusMetabolism and nutrition disorders0/100/101/400/400/400/40
Most frequent other events
Showing 10 of 24
Most frequent other events
EventControl GroupGSK692342_F1 GroupGSK692342_F2 GroupGSK692342_F3 GroupGSK692342_F4D1 GroupGSK692342_F4D2 Group
PainGeneral disorders9/105/1038/4037/4037/4036/40
HeadacheGeneral disorders5/106/1025/4027/4030/4026/40
MyalgiaGeneral disorders3/103/1025/4023/4024/4029/40
Temperature (Axillary)General disorders5/101/1017/409/4017/4028/40
MalaiseGeneral disorders5/103/1023/4025/4023/4026/40
NasopharyngitisInfections and infestations4/105/1015/4010/4018/4016/40
CoughRespiratory, thoracic and mediastinal disorders0/104/103/406/4013/4011/40
FatigueGeneral disorders2/101/107/408/4013/4010/40
SwellingGeneral disorders1/101/1010/4010/4012/4012/40
Gastro-intestinal symptomsGeneral disorders3/103/108/409/4011/4010/40

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Control GroupGSK692342_F1 GroupGSK692342_F2 GroupGSK692342_F3 GroupGSK692342_F4D1 GroupGSK692342_F4D2 GroupTotal
Mean32.1 ± 8.1036.0 ± 5.1430.6 ± 9.1433.5 ± 8.7330.6 ± 9.1731.5 ± 8.8331.92 ± 8.67
Sex: Female, Male
Sex: Female, Male(Participants)Control GroupGSK692342_F1 GroupGSK692342_F2 GroupGSK692342_F3 GroupGSK692342_F4D1 GroupGSK692342_F4D2 GroupTotal
Female9733363126142
Male137491438
08

Study locations

1 site
  • GSK Investigational Site
    Manila, 1000, Philippines
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00621322
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Feb 22, 2008
Start date
Apr 3, 2008
Primary completion
Apr 3, 2009
Completion
Apr 3, 2009
Results posted
Feb 3, 2017
Last update
Aug 24, 2018

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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