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NCT Number: NCT02153320

Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers

The purpose of this long-term follow-up study was to evaluate the persistence of the cellular and the humoral immune response 4 years after the first dose of GSK Biologicals' investigational vaccine formulations containing HBsAg (used as a model antigen) and an adjuvant.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

22 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Brussels, Belgium

Loading trial locations.

About this study

Subjects in this long-term follow-up study were recruited among those subjects who completed the study 287615 (NCT00508833) and who were enrolled in specific groups. All subjects were vaccinated in the study 287615 (NCT00508833) according to a 0, 1, 10 month schedule. No new subjects were enrolled and no vaccine was administered in this long-term follow-up study. There was a single visit at Year 4 at which blood samples for immunogenicity assays were taken.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • Subjects who took part in and completed study 287615 (NCT00508833).
  • Written informed consent obtained from the subject.
  • Healthy subjects as established by medical history before entering into the study.

Exclusion criteria

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the blood sampling, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to the blood sampling.
  • Administration of immunoglobulins within the three months preceding the blood sampling or planned administration during the study period.
  • Pregnant or lactating female.
  • Documented HIV-positive subject.

Treatment and study plan

blood sampling

Procedure

Single blood sample taken from subjects who had participated in the study 287615 (NCT00508833).

Primary outcomes

  1. Frequency of CD4 and CD8 T cells expressing IFN-γ and/or TNF-α and/or IL-2 and/or CD40L upon short term in vitro stimulation with HbsAg derived peptides using cytokine flow cytometry.

    Time frame: Week 48.

    The blood samples at Week 48 were taken during the primary study 287615 (NCT00508833).

  2. Frequency of CD4 and CD8 T cells expressing IFN-γ and/or TNF-α and/or IL-2 and/or CD40L upon short term in vitro stimulation with HbsAg derived peptides using cytokine flow cytometry.

    Time frame: Week 78.

    The blood samples at Week 78 were taken during the primary study 287615 (NCT00508833).

  3. Frequency of CD4 and CD8 T cells expressing IFN-γ and/or TNF-α and/or IL-2 and/or CD40L upon short term in vitro stimulation with HbsAg derived peptides using cytokine flow cytometry.

    Time frame: Year 4.

Secondary outcomes

  1. Anti-HBs antibody titres as measured by ELISA.

    Time frame: Week, 48, Week 78, Year 4.

    The blood samples at Week 48 and Week 78 were taken during the primary study 287615 (NCT00508833).

  2. Exploratory analysis of proteins and low molecular weight biomolecules in the serum using ELISA and other techniques to be defined.

    Time frame: Day 0, Day 1.

    The blood samples at Day 0 and Day 1 were taken during the primary study 287615 (NCT00508833).

  3. Frequency of HBsAg specific memory B cells by B Cell Elispot assay.

    Time frame: Week 48, Week 78, Year 4.

    The blood samples at Week 48 and Week 78 were taken during the primary study 287615 (NCT00508833).

  4. Frequency of HBs-specific or non specific T regulatory cells using cytokine flow cytometry and other techniques to be defined.

    Time frame: Day 0, Week 6, Week 46, Week 48.

    The blood samples at Day 0, Week 6, Week 46 and Week 48 were taken during the primary study 287615 (NCT00508833).

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Long-term Follow-up of a Phase I/II Study to Compare the Persistence and to Perform in Depth Characterisation of the Cellular and Humoral Immune Response Following Vaccinations With GSK Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Jun 3, 2014
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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