NCT01777295

Brief Summary

This study aims to develop innovative immunological read-outs and new technologies in order to further characterise the early immune response and its kinetics as well as the adaptive immune responses to adjuvanted vaccines. This study will also evaluate the reactogenicity in healthy, hepatitis B virus naive adults vaccinated with the hepatitis B surface antigen in combination with a GSK Biologicals' Adjuvant System.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
28 days until next milestone

Study Start

First participant enrolled

February 25, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2016

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

January 4, 2019

Completed
Last Updated

January 4, 2019

Status Verified

June 1, 2018

Enrollment Period

3.2 years

First QC Date

January 24, 2013

Results QC Date

May 17, 2017

Last Update Submit

June 29, 2018

Conditions

Hepatitis B

Keywords

AdultsReactogenicityNaiveImmune responsesRead-outsHepatitis BHealthy

Outcome Measures

Primary Outcomes (40)

  • Concentrations of Cytokines and Chemokines - Step 1

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    At Day -30 prior to placebo administration

  • Cytokines and Chemokines Concentrations - Step 1

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-placebo at Day -30 plus 1.5 Hours

  • Concentrations of Cytokines and Chemokines in Step 1

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-placebo at Day -30 plus 3 Hours

  • Concentrations of Cytokines and Chemokines During Step 1

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-placebo at Day -30 plus 6 Hours

  • Concentrations of Cytokines/Chemokines - Step 1

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-placebo at Day -30 plus 9 Hours

  • Concentrations of Cytokines/Chemokines in Step 1

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-placebo at Day -30 plus 12 Hours

  • Concentrations of Cytokines/Chemokines During Step 1

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-placebo at Day -30 plus 18 Hours

  • Cytokines and Chemokines Concentrations in Step 1

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-placebo at Day -29

  • Cytokines and Chemokines Concetrations During Step 1

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-placebo at Day -28

  • Cytokines/Chemokines Concentrations in Step 1

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-placebo at Day -27

  • Cytokines and Chemokines Concentrations During Step 1

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-placebo at Day -23

  • Concentrations of Cytokines and Chemokines - Study Step 1

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Pre-dose1 at Day 0

  • Concentrations of Cytokines and Chemokines in Step 1 of Study

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-dose1 at Day 0 plus 1.5 Hours

  • Concentrations of Cytokines and Chemokines During Step 1 of Study

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-dose1 at Day 0 plus 6 Hours

  • Cytokines and Chemokines Concentrations - Study Step 1

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-dose1 at Day 0 plus 12 Hours

  • Cytokines and Chemokines Concentrations in Step 1 of Study

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-dose1 at Day 0 plus 18 Hours

  • Cytokines and Chemokines Concentrations During Step 1 of Study

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-dose1 at Day 1

  • Cytokines/Chemokines Concentrations - Study Step 1

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-dose1 at Day 2

  • Cytokines/Chemokines Concentrations in Step 1 of Study

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-dose1 at Day 7

  • Cytokines/Chemokines Concentrations During Step 1 of Study

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-dose1 at Day 30

  • Plasma Concentrations of Cytokines and Chemokines - Step 1

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-dose 2 at Day 30 plus 1.5 Hours

  • Plasma Concentrations of Cytokines and Chemokines - Study Step 1

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-dose 2 at Day 30 plus 3 Hours

  • Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-dose 2 at Day 30 plus 6 hours

  • Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-dose 2 at Day 30 plus 9 Hours

  • Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-dose 2 at Day 30 plus 12 Hours

  • Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-dose 2 at Day 30 plus 18 Hours

  • Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-dose 2 at Day 31

  • Concentrations of Plasma Cytokines and Chemokines - Step 1

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-dose 2 at Day 32

  • Concentrations of Plasma Cytokines and Chemokines in Step 1

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-dose 2 at Day 33

  • Concentrations of Plasma Cytokines and Chemokines During Step 1

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Post-dose 2 at Day 37

  • Concentrations of Cytokines and Chemokines - Step 2

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.

    Pre-dose 1 at Day 0

  • Cytokines and Chemokines Concentrations - Step 2

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\_2 Group.

    Post-dose 1 at Day 1

  • Concentrations of Cytokines and Chemokines During Step 2

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\_2 Group.

    Post-dose 1 at Day 30

  • Concentrations of Cytokines and Chemokines in Step 2

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\_2 Group.

    Post-dose2 at Day 30 plus 6 Hours

  • Concentrations of Cytokines/Chemokines - Step 2

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\_2 Group.

    Post-dose 2 at Day 31

  • Concentrations of Cytokines/Chemokines in Step 2

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\_2 Group.

    Post-dose 2 at Day 37

  • Concentrations of Cytokines/Chemokines During Step 2

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the Engerix-B\_2 Group.

    Post-dose 2 at Day 180

  • Plasma Concentrations of Cytokines and Chemokines - Study Step 2

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.The analysis was performed only on theEngerix-B\_2 Group.

    Post-dose 3 at Day 180 plus 6 Hours

  • Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the Engerix-B\_2 Group.

    Post-dose 3 at Day 181

  • Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study

    Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the Engerix-B\_2 Group.

    Post-dose 3 at Day 187

Secondary Outcomes (64)

  • Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 1

    At Day 0 (PRE) and Day 60 (D60) post-vaccination

  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1

    During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across doses

  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1

    During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across doses

  • Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1

    Up to 4 days post-placebo/vaccine administration.

  • Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 1

    Within the 28-day (Days 0-27) post-placebo (PP) and post-product administration period.

  • +59 more secondary outcomes

Study Arms (2)

HBsAg/AS Group

EXPERIMENTAL

Subjects in this group received 1 dose of Placebo at Day -30 followed by 2 doses of HBsAg/AS, at Day 0 and Day 30.

Biological: Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A.Biological: Placebo

Engerix-B Group

ACTIVE COMPARATOR

Subjects in this group received 1 dose of Placebo at Day -30 followed by 3 doses of Engerix-B at Day 0, Day 30 and Day 180.

Biological: EngerixTM-BBiological: Placebo

Interventions

Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A.BIOLOGICAL

Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Also known as: HBsAg/AS
HBsAg/AS Group
EngerixTM-BBIOLOGICAL

Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Also known as: Engerix-B
Engerix-B Group
PlaceboBIOLOGICAL

Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Engerix-B GroupHBsAg/AS Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 45 years of age at the time of first study product administration
  • Written informed consent obtained from the subject
  • Healthy subjects, in the opinion of the investigator, as established by medical history, clinical examination, and clinical laboratory assessment with no active disease that could interfere with the study endpoints, before entering into the study
  • Body Mass Index (BMI) between 18.5 and 30 kg/m2
  • Female subjects of non-childbearing potential may be enrolled in the study
  • \- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
  • has practiced adequate contraception for 30 days prior to first study product administration and
  • has a negative pregnancy test on the day of placebo administration/ vaccination, and
  • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study.

You may not qualify if:

  • Known history of HBV infection.
  • Previous vaccination against hepatitis B.
  • Positive for anti-hepatitis B surface (HBs) antibodies, anti-hepatitis B core (HBc) antibodies, HBsAg, HCV antibodies and/or HIV.
  • Any previous administration of vaccine components.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first study product administration, or planned use during the study period.
  • No significant dietary restrictions or life-threatening food allergies.
  • Regular use of non steroidal anti-inflammatory drugs within 1 month prior to first study product administration.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first study product administration.. Inhaled and topical steroids are allowed.
  • Planned administration / administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first study product administration and during the entire study period (both Steps), with the exception of the influenza vaccine (pandemic or seasonal) which can be administered \> 21 days preceding or \> 21 days following each placebo/vaccine administration.
  • Administration of immunoglobulins and/or any blood products within the last 3 months preceding the first study product administration or planned administration during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV based on screening evaluations and on medical history and physical examination.
  • History of or current bleeding or coagulation disorder.
  • Any known or clinical signs of anaemia or any clinical condition (including vascular disorder) that would preclude frequent blood drawings.
  • Poor venous access as assessed at screening by the investigator.
  • Blood loss, including blood donation, of more than 300 mL within 90 days before the first study product administration.
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Antwerp, 2060, Belgium

Location

Related Publications (3)

  • Bechtold V, Smolen KK, Burny W, de Angelis SP, Delandre S, Essaghir A, Marchant A, Ndour C, Taton M, van der Most R, Willems F, Didierlaurent AM. Functional and epigenetic changes in monocytes from adults immunized with an AS01-adjuvanted vaccine. Sci Transl Med. 2024 Jul 31;16(758):eadl3381. doi: 10.1126/scitranslmed.adl3381. Epub 2024 Jul 31.

    PMID: 39083587DERIVED

  • Burny W, Herve C, Caubet M, Yarzabal JP, Didierlaurent AM. Utility of urinary cytokine levels as predictors of the immunogenicity and reactogenicity of AS01-adjuvanted hepatitis B vaccine in healthy adults. Vaccine. 2022 Apr 26;40(19):2714-2722. doi: 10.1016/j.vaccine.2022.03.050. Epub 2022 Mar 30.

    PMID: 35367070DERIVED

  • Burny W, Marchant A, Herve C, Callegaro A, Caubet M, Fissette L, Gheyle L, Legrand C, Ndour C, Tavares Da Silva F, van der Most R, Willems F, Didierlaurent AM, Yarzabal J; ECR-008 study group. Inflammatory parameters associated with systemic reactogenicity following vaccination with adjuvanted hepatitis B vaccines in humans. Vaccine. 2019 Mar 28;37(14):2004-2015. doi: 10.1016/j.vaccine.2019.02.015. Epub 2019 Mar 5.

    PMID: 30850240DERIVED

MeSH Terms

Conditions

Hepatitis B

Interventions

Hepatitis B Surface AntigensEngerix-B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Hepatitis B AntigensHepatitis AntigensAntigens, ViralViral ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigensBiological Factors

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2013

First Posted

January 28, 2013

Study Start

February 25, 2013

Primary Completion

May 17, 2016

Study Completion

September 13, 2016

Last Updated

January 4, 2019

Results First Posted

January 4, 2019

Record last verified: 2018-06

Locations

BE(1)