Brief Summary

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Official Title: "Safety and Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A"

The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' investigational Herpes Zoster vaccine GSK1437173A when administered as 2 doses or 3 doses to hematopoietic stem cell transplant (HCT) recipients.

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Study Primary Completion Date: April 2011

Detailed Clinical Trial Description

The Protocol Posting has been updated following Protocol amendment 2, Sep 2009. The sections impacted are: eligibility criteria.

Interventions Used in this Clinical Trial

• Biological: Herpes Zoster Vaccine 1437173A
  • Different formulations of investigational vaccine (GSK 1437173A) administered in 2 or 3 doses intramuscularly.
• Biological: Placebo vaccine (saline)
  • 1 or 3 doses of Placebo (saline) injected intramuscularly.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Group A
• Experimental: Group B
• Experimental: Group C
• Placebo Comparator: Group D

Outcome Measures for this Clinical Trial

Primary Measures

• Occurrence, intensity of solicited local and general adverse events (AEs)
  • Time Frame: Days 0-6 after each vaccination
    Safety Issue?: No
• Occurrence, intensity of unsolicited AEs
  • Time Frame: Days 0-29 after each vaccination
    Safety Issue?: No
• Occurrence, intensity of unsolicited AEs
  • Time Frame: Any time during the study up to Day 29 after the last vaccination
    Safety Issue?: No
• Occurrence of all serious adverse events (SAEs)
  • Time Frame: During the entire study period
    Safety Issue?: No
• Occurrence and relationship to vaccination of any new onset of autoimmune diseases and other immune mediated inflammatory disorders
  • Time Frame: During the entire study period
    Safety Issue?: No
• Hematological and biochemical evaluations
  • Time Frame: Months 0, 1, 2, 3 and 4
    Safety Issue?: No
• Frequency of CD4 T cells specific for Varicella Zoster Virus (VZV) antigens.
  • Time Frame: Month 4
    Safety Issue?: No
• VZV-specific antibody concentrations
  • Time Frame: Month 4
    Safety Issue?: No

Secondary Measures

• Frequency of CD4 T cells specific for VZV antigens
  • Time Frame: Months 0, 1, 2, 3, 4 and 15
    Safety Issue?: No
• VZV-specific antibody concentrations
  • Time Frame: Months 0, 1, 2, 3, 4 and 15
    Safety Issue?: No
• Confirmed Herpes Zoster (HZ) cases
  • Time Frame: During the entire study period
    Safety Issue?: No
• HZ pain severity in subjects with confirmed HZ
  • Time Frame: 4-week period following the onset of the HZ rash
    Safety Issue?: No
• HZ disease severity as determined by the total score of HZ-associated disease in subjects with confirmed HZ
  • Time Frame: 4-week period following the onset of the HZ rash
    Safety Issue?: No
• Occurrence of Postherpetic Neuralgia (PHN) in the entire study cohort
  • Time Frame: During the entire study period
    Safety Issue?: No
• Incidence of other HZ-associated complications following the onset of HZ rash in subjects with confirmed HZ in the entire study cohort.
  • Time Frame: During the entire study period
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol;
• Male and female subjects at least 18 years old at the time of vaccination;
• Serological evidence of prior VZV infection for all subjects born in 1980 or later and for subjects born outside the US before 1980 in a tropical or sub-tropical region. No testing for serological evidence of prior VZV infection is required for US subjects born before 1980;
• Has undergone autologous HCT within the past 50-70 days for treatment of Hodgkin lymphoma, non-Hodgkin lymphoma (T or B cell), myeloma or acute myeloid leukemia, and there are no plans for additional HCTs
• Written informed consent obtained from the subject;
• If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria

• Use of any investigational non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;
• Administration or planned administration of a vaccine that is not part of the study protocol since transplantation. However licensed non-replicating vaccines (i.e. inactivated and subunit vaccines, including inactivated and subunit influenza vaccines, with or without adjuvant) may be administered up to 8 days prior to dose 1;
• Administration of immunoglobulins since transplantation;
• Previous vaccination against varicella or HZ;
• History of HZ within the previous 12 months;
• Known exposure to VZV since transplantation;
• Evidence of active infection at the time of enrollment including a temperature of ≥ 37.5° C or any serious HCT-related complication;
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
• Hypersensitivity or intolerance to acyclovir or valacyclovir;
• Pregnant or lactating female.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • GlaxoSmithKline
• Provider of Information About this Clinical Study
  • Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
• Overall Official(s)
  • GSK Clinical Trials, Study Director, GlaxoSmithKline