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GSK Biologicals' investigational TB vaccine GSK 692342

Phase 2

Tuberculosis | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Mar 22, 2019

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Trial Design

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Total Trials1

Total Enrollment20

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Clinical trial landscape

GSK Biologicals' investigational TB vaccine GSK 692342 · 1 trial · 1 indication

Phase 2 1

NCT01669096Study in Healthy Adults to Evaluate Gene Activation After Vaccination With GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342Tuberculosis

COMPLETED20 Analytics

PHASE2COMPLETED

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

Tuberculosis

NCT0166909620

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Study Endpoints

Primary Endpoints

Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples

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.

Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation CD4+/CD8+ T Cells Expressing at Least Two Different Immune Markers

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

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)

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)

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)

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)

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)

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)

At Day 60 post-Dose 2

Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28)

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)

At Day 60 post Dose 2

Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers,Post Dose 2 (M43 to M56)

At Day 60 (post-Dose 2)

Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63)

At Day 60 post- Dose 2

Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M1 to M14)

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)

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)

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)

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)

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)

At Day 60 post-Dose 2

Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28)

At Day 60 post -Dose 2

Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42)

At Day 60 post- Dose 2

Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M43 to M56)

At Day 60 post-Dose 2

Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63)

At Day 60 post Dose 2

Number of Subjects With Serious Adverse Events (SAEs)

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

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

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)

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)

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.

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Study Design & Arms

AllocationNA

MaskingNONE

ModelSINGLE_GROUP

PurposeOTHER

Treatment Arms

Arm	Type	Description
GSK 692342 Group	EXPERIMENTAL	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.

Interventions

Name	Type	Description
GSK Biologicals' investigational TB vaccine GSK 692342	BIOLOGICAL	2 doses administered intramuscularly according to a 0, 1 month schedule (Day 0 and Day 30), in the deltoid region of the arm

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Eligibility Criteria

Age Range18 Years to 50 Years

SexALL

Healthy VolunteersYes

Study Sites1

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. * Hea...

Countries:Belgium

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Competitive Landscape -Tuberculosis 7 trials

Company	Ticker	Trials	Lead Phase	Drugs
Viatris, Inc.	VTRS	1	PHASE3	Bedaquiline
Johnson & Johnson	JNJ	1	PHASE2	Bedaquiline, Background Regimen
BioNTech SE Sponsored ADR	BNTX	1	PHASE1	BNT164a1, BNT164b1

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GSK Biologicals' investigational TB vaccine GSK 692342

Success Probability

Market & Valuation

Trial Design

FDA Designations

Clinical trial landscape

Study Endpoints

Primary Endpoints

Study Design & Arms

Treatment Arms

Interventions

Eligibility Criteria

Competitive Landscape -Tuberculosis 7 trials