Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM).

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00792623
First received: November 17, 2008
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

This study aims to assess the immunogenicity and safety of varicella vaccination in a population of autologous peripheral stem cell/ bone marrow transplantation recipients who have reached at least four months post-transplantation.


Condition Intervention Phase
Varicella
Biological: VarilrixTM
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Immunogenicity and Safety of GSK Biologicals' Varicella Vaccine (VARILRIXTM), Given as a Primary Vaccination at 4.5 M and 6.5 M Post-transplantation, in Autologous Stem Cell/Bone Marrow Transplantation Recipients Aged 18 Years and Older.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Varicella vaccine response and Geometric mean titres (GMTs) [ Time Frame: At 8 months post-transplantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vaccine response and GMTs [ Time Frame: A 6.5 months post-transplantation ] [ Designated as safety issue: No ]
  • Seroconversion/Seropositivity and GMTs [ Time Frame: At pre-transplantation, 4.5, 12 and 24 months post-transplantation. ] [ Designated as safety issue: No ]
  • Lymphoproliferation stimulation index [cell-mediated immunity (CMI)] [ Time Frame: At pre-transplantation, 4.5, 6.5, 8, 12 and 24 months post-transplantation. ] [ Designated as safety issue: No ]
  • Interferon-γ (IFN-γ) and Interleukin-5 (IL-5) index [ Time Frame: At pre-transplantation, 4.5, 6.5, 8, 12 and 24 months post-transplantation ] [ Designated as safety issue: No ]
  • Occurrence of varicella zoster virus (VZV) infections [ Time Frame: Up to 24 months post-transplantation ] [ Designated as safety issue: No ]
  • Occurrence of solicited local adverse events [ Time Frame: During the 8-day follow-up period after each vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of solicited general adverse events [ Time Frame: During the 43-day follow-up period after each vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 43 day follow-up period after each vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of Serious Adverse Events [ Time Frame: Over the active phase of the study ] [ Designated as safety issue: Yes ]
  • Retrospective analysis on the serological status, GMTs and stimulation index (CMI) and the occurrence of VZV infections to compare patients given fludarabine-based regimens compared to non-fludarabine regimens. [ Time Frame: At pre-transplantation, 4.5, 6.5, 8, 12 and 24 months post-transplantation ] [ Designated as safety issue: No ]
  • Retrospective analysis of the correlation between the CD4, CD8 and CD20 levels and the immune response (in terms of seropositivity rate) to the vaccine. [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: September 2003
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: VarilrixTM
Subcutaneous injection, 2 doses

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Screening phase:

  • A male or female ≥ 18 years of age at the time of study entry.
  • Written informed consent obtained from the subject prior to study entry.
  • Patients who are planned to undergo autologous peripheral stem cell/ bone marrow transplantation.
  • Subjects who the investigator believes can and will comply with the requirements of the protocol
  • If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for 10 months after transplantation.

Active phase:

  • Patients who are confirmed to have undergone autologous peripheral stem cell/ bone marrow transplantation.
  • If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for 10 months after transplantation.

Exclusion Criteria:

Screening phase:

  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions in the 10 months post-transplantation.
  • History of allergy to any component of the vaccine.
  • Patients with difficult to treat disease who are likely to relapse within 6 months post-transplantation.
  • Current drug and/or alcohol abuse.

Active phase:

  • Use of any investigational or non-registered product (drug or vaccine) during the active phase of the study period.
  • Use of immunosuppressants or other immune-modifying drugs within 14 days preceding the administration of the first dose of the study vaccine or planned use during the active phase of the study period.
  • Use of rituximab (MabThera) more than 60 days after transplant.
  • Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions in the 10 months post-transplantation.
  • History of allergy to any component of the vaccine
  • Patients with VZV disease after transplantation and prior to vaccination.
  • Ongoing requirement for antiviral therapy with anti-VZV activity beyond 4 months post-transplantation
  • Patients with difficult to treat disease who are likely to relapse within 6 months post-transplantation.
  • Current drug and/or alcohol abuse.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792623

Locations
Australia, Victoria
GSK Investigational Site
East Melbourne, Victoria, Australia, 3002
GSK Investigational Site
Melbourne, Victoria, Australia, 3050
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00792623     History of Changes
Other Study ID Numbers: 208133/178
Study First Received: November 17, 2008
Last Updated: September 29, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
Varicella
VarilrixTM

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on August 26, 2014