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Study in Healthy Adults to Evaluate Gene Activation After Vaccination With GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342

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ClinicalTrials.gov Identifier: NCT01669096
Recruitment Status : Completed
First Posted : August 20, 2012
Results First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
Aeras
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE August 16, 2012
First Posted Date  ICMJE August 20, 2012
Results First Submitted Date  ICMJE September 13, 2017
Results First Posted Date  ICMJE March 22, 2019
Last Update Posted Date March 22, 2019
Actual Study Start Date  ICMJE August 21, 2012
Actual Primary Completion Date December 6, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples [ Time Frame: At Day 0 prior to Dose 1 ]
    Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.
  • Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples [ Time Frame: At Day 30 post-Dose 1 ]
    Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.
  • Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples [ Time Frame: At Day 31 post-Dose 2 ]
    Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.
  • Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples [ Time Frame: At Day 37 post-Dose 2 ]
    Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.
  • Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples [ Time Frame: At Day 40 post-Dose 2 ]
    Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.
  • Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples [ Time Frame: At Day 44 post-Dose 2 ]
    Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.
  • Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples [ Time Frame: At Day 47 post-Dose 2 ]
    Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.
  • Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation CD4+/CD8+ T Cells Expressing at Least Two Different Immune Markers [ Time Frame: At Day 0 prior to Dose 1 ]
    Among immune markers expressed were interleukin-2 (IL-2) and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ) and/or cluster of differentiation 40-ligand (CD40-L) and/or IL-13 and/or IL-17. The analysis of cytokines expression was performed by flow cytometry using intracellular cytokine staining (ICS) on frozen peripheral blood mononuclear cell (PBMCs).
  • Frequency of M72 Fusion Protein Specific Cluster of Differentiation CD4+/CD8+ T Cells Expressing at Least Two Different Immune Markers [ Time Frame: At Day 60 post-Dose 2 ]
    Among immune markers expressed were interleukin-2 (IL-2) and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ) and/or cluster of differentiation 40-ligand [CD40-L] and/or IL-13 and/or IL-17. The analysis of cytokines expression was performed by flow cytometry using intracellular cytokine staining (ICS) on frozen peripheral blood mononuclear cell (PBMCs).
  • Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M1 to M 14) [ Time Frame: At Day 0 prior -Dose 1 ]
    Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M1=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M2=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M3=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M4=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M5=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M6=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M7=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M8=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M9=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M10=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M11=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M12=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M13=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M14=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-).
  • Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) [ Time Frame: At Day 0 prior-Dose 1 ]
    Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M15=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M16=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M17=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M18=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M19=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M20=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M21=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M22=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M23=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M24=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M25=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M26=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M27=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M28=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-).
  • Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) [ Time Frame: At Day 0 prior - Dose 1 ]
    Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M29=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M30=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M31=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M32=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M33=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M34=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M35=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M36=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M37=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M38=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M39=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M40=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M41=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M42=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+).
  • Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) [ Time Frame: At Day 0 (prior- Dose 1) ]
    Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M43=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M44=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M45=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M46=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M47=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M48=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M49=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M50=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M51=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M52=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M53=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M54=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M55=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M56=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-).
  • Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M57 to M63) [ Time Frame: At Day 0 (prior to Dose 1) ]
    Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M57=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M58=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M59=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M60=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M61=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M62=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M63=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+).
  • Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) [ Time Frame: At Day 60 post-Dose 2 ]
    Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M1=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M2=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M3=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M4=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M5=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M6=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M7=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M8=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M9=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M10=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M11=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M12=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M13=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M14=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-).
  • Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) [ Time Frame: At Day 60 post - Dose 2 ]
    Expressed immune markers combinations for CD4+/CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M15=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M16=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M17=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M18=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M19=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M20=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M21=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M22=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M23=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M24=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M25=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M26=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M27=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M28=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-).
  • Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) [ Time Frame: At Day 60 post Dose 2 ]
    Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M29=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M30=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M31=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M32=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M33=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M34=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M35=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M36=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M37=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M38=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M39=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M40=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M41=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M42=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+).
  • Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers,Post Dose 2 (M43 to M56) [ Time Frame: At Day 60 (post-Dose 2) ]
    Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M43=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M44=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M45=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M46=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M47=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M48=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M49=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M50=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M51=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M52=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M53=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M54=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M55=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M56=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-).
  • Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63) [ Time Frame: At Day 60 post- Dose 2 ]
    Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M57=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M58=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M59=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M60=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M61=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M62=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M63=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+).
  • Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M1 to M14) [ Time Frame: At Day 0 prior-Dose 1 ]
    Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M1=CD8.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M2=CD8.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M3=CD8.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M4=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M5=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M6=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M7=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M8=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M9=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M10=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M11=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M12=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M13=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M14=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+).
  • Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) [ Time Frame: At Day 0 prior -Dose 1 ]
    Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M15=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M16=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M17=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M18=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M19=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M20=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M21=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M22=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M23=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M24=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M25=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M26=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M27=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M28=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+).
  • Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) [ Time Frame: At Day 0 prior- Dose 1 ]
    Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M29=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M30=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M31=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M32=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M33=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M34=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M35=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M36=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M37=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M38=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M39=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M40=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M41=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M42=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+).
  • Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M43 to M56) [ Time Frame: At Day 0 prior to Dose 1 ]
    Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M43=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M44=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M45=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M46=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M47=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M48=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M49=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M50=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M51=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M52=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M53=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M54=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M55=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M56=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-).
  • Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M57 to M63) [ Time Frame: At Day 0 (prior to Dose 1) ]
    Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M57=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M58=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M59=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M60=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M61=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M62=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M63=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+).
  • Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14) [ Time Frame: At Day 60 post-Dose 2 ]
    Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M1=CD8.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M2=CD8.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M3=CD8.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M4=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M5=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M6=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M7=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M8=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M9=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M10=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M11=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M12=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M13=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M14=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+).
  • Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28) [ Time Frame: At Day 60 post -Dose 2 ]
    Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M15=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M16=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M17=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M18=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M19=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M20=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M21=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M22=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M23=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M24=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M25=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M26=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M27=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M28=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+).
  • Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42) [ Time Frame: At Day 60 post- Dose 2 ]
    Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M29=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M30=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M31=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M32=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M33=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M34=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M35=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M36=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M37=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M38=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M39=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M40=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M41=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M42=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+).
  • Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M43 to M56) [ Time Frame: At Day 60 post-Dose 2 ]
    Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M43=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M44=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M45=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M46=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M47=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M48=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M49=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M50=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M51=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M52=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M53=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M54=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M55=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M56=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-).
  • Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63) [ Time Frame: At Day 60 post Dose 2 ]
    Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M57=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M58=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M59=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M60=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M61=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M62=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M63=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+).
  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Day 0 to Month 7) ]
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    Assessed solicited general symptoms were Fatigue, Gastrointestinal symptoms, Headache, Malaise, Myalgia and Fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = incidence of any particular symptom regardless of intensity grade. Grade 3 = incidence of a particular symptom that prevented normal, everyday activity. Grade 3 fever = axillary temperature above (>) 39.5 °C. Related = general symptom assessed by the investigator as causally related to the study vaccination.
  • Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During the 30-day (Days 0-29) post-vaccination period ]
    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 = an AE assessed by the investigator as causally related to the study vaccination.
  • Number of Subjects With Potential Immune-Mediated Disease(s) (pIMDs) [ Time Frame: During the entire study period (From Day 0 to Month 7) ]
    pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Original Primary Outcome Measures  ICMJE
 (submitted: August 16, 2012)
  • Evaluation of Interferon gamma (IFN-γ) secretion in serum [ Time Frame: Prior to dose 1 (Day 0) ]
  • Evaluation of Interferon gamma (IFN-γ) secretion in serum [ Time Frame: Post dose 1 (Day 7) ]
  • Evaluation of Interferon gamma (IFN-γ) secretion in serum [ Time Frame: Post dose 1 (Day 30) ]
  • Evaluation of Interferon gamma ( IFN-γ) secretion in serum [ Time Frame: Post dose 2 (Day 37) ]
  • Evaluation of Interferon gamma (IFN-γ ) secretion in serum [ Time Frame: Post dose 2 (Day 60) ]
  • Evaluation of Interferon gamma (IFN -γ) secretion in serum [ Time Frame: Post dose 2 (Day 210) ]
  • Evaluation of cell mediated immunogenicity (CMI) responses with respect to components of the study vaccine [ Time Frame: Prior to dose 1 (Day 0) ]
  • Evaluation of cell mediated immunogenicity (CMI) responses with respect to components of the study vaccine [ Time Frame: Post dose 2 (Day 60) ]
  • Occurrence of Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (Day 0 to Month 7) ]
  • Occurrence of solicited local and general adverse events (AEs) [ Time Frame: During the 7 day follow-up period following each vaccination (day of vaccination and 6 subsequent days) ]
  • Occurrence of unsolicited AEs [ Time Frame: During the 30 day follow-up period following each vaccination (day of vaccination and 29 subsequent days) ]
  • Occurrence of all potential Immune-Mediated Disease(s) (pIMDs) [ Time Frame: During the entire study period (Day 0 to Month 7) ]
Change History Complete list of historical versions of study NCT01669096 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study in Healthy Adults to Evaluate Gene Activation After Vaccination With GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342
Official Title  ICMJE Evaluation of the Kinetics of mRNA Expression After Two Doses of GSK Biologicals' Candidate Tuberculosis (Tuberculosis) Vaccine GSK 692342 in Healthy Adults
Brief Summary The purpose of this study is to assess the safety and immunogenicity of two doses of the TB vaccine administered according to a 0, 1 month schedule. In, addition, blood samples collected at different time points after vaccination will be analysed to see when exactly genes are activated by the vaccine using an assay called mRNA expression profiling. The different methods for mRNA expression profiling using whole blood samples versus Peripheral Blood Mononuclear cell(s) (PBMCs), will also be compared.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Tuberculosis
Intervention  ICMJE Biological: GSK Biologicals' investigational TB vaccine GSK 692342
2 doses administered intramuscularly according to a 0, 1 month schedule (Day 0 and Day 30), in the deltoid region of the arm
Study Arms  ICMJE Experimental: GSK 692342 Group
Healthy male and female subjects, between and including 18 to 50 years of age, who received 2 doses of GSK 692342 vaccine administered intramuscularly in the deltoid region of the arm, at Days 0 and 30.
Intervention: Biological: GSK Biologicals' investigational TB vaccine GSK 692342
Publications * van den Berg RA, De Mot L, Leroux-Roels G, Bechtold V, Clement F, Coccia M, Jongert E, Evans TG, Gillard P, van der Most RG. Adjuvant-Associated Peripheral Blood mRNA Profiles and Kinetics Induced by the Adjuvanted Recombinant Protein Candidate Tuberculosis Vaccine M72/AS01 in Bacillus Calmette-Guérin-Vaccinated Adults. Front Immunol. 2018 Mar 26;9:564. doi: 10.3389/fimmu.2018.00564. eCollection 2018.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 16, 2012)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 24, 2013
Actual Primary Completion Date December 6, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • A male or female between, and including, 18 and 50 years of age at the time of obtaining informed consent.
  • Written informed consent obtained from the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Known BCG vaccination or presence of a BCG scar.
  • Seronegative for human immunodeficiency virus-1.
  • Female of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of screening and the day of first vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

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 (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent). Inhaled and topical steroids are allowed.
  • Administration of long-acting immune-modifying drugs starting 2 years before the first dose and planned administration during the study.
  • Planned administration/administration of a vaccine/product not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine and ending at the last study visit.
  • 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 vaccine/product (pharmaceutical product or device).
  • History of TB disease.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • QuantiFERON® TB Gold positive test result.
  • History of medically confirmed autoimmune disease.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • History of any reaction of hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01669096
Other Study ID Numbers  ICMJE 116777
2012-002541-37 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria: 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.
URL: https://clinicalstudydatarequest.com
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Aeras
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date March 2019

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