Safety & Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A - Full Text View

Purpose

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.

Condition	Intervention	Phase
Herpes Zoster in Autologous Hematopoietic Stem Cell Transplantation Recipients	Biological: Herpes Zoster Vaccine 1437173A Biological: Placebo vaccine (saline)	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Shingles

Drug Information available for: Herpes Zoster Vaccine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence, intensity of solicited local and general adverse events (AEs) [ Time Frame: Days 0-6 after each vaccination ] [ Designated as safety issue: No ]
Occurrence, intensity of unsolicited AEs [ Time Frame: Days 0-29 after each vaccination ] [ Designated as safety issue: No ]
Occurrence, intensity of unsolicited AEs [ Time Frame: Any time during the study up to Day 29 after the last vaccination ] [ Designated as safety issue: No ]
Occurrence of all serious adverse events (SAEs) [ Time Frame: During the entire study period ] [ Designated as 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 ] [ Designated as safety issue: No ]
Hematological and biochemical evaluations [ Time Frame: Months 0, 1, 2, 3 and 4 ] [ Designated as safety issue: No ]
Frequency of CD4 T cells specific for Varicella Zoster Virus (VZV) antigens. [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
VZV-specific antibody concentrations [ Time Frame: Month 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Frequency of CD4 T cells specific for VZV antigens [ Time Frame: Months 0, 1, 2, 3, 4 and 15 ] [ Designated as safety issue: No ]
VZV-specific antibody concentrations [ Time Frame: Months 0, 1, 2, 3, 4 and 15 ] [ Designated as safety issue: No ]
Confirmed Herpes Zoster (HZ) cases [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]
HZ pain severity in subjects with confirmed HZ [ Time Frame: 4-week period following the onset of the HZ rash ] [ Designated as 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 ] [ Designated as safety issue: No ]
Occurrence of Postherpetic Neuralgia (PHN) in the entire study cohort [ Time Frame: During the entire study period ] [ Designated as 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 ] [ Designated as safety issue: No ]

Enrollment:	122
Study Start Date:	July 2009
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A	Biological: Herpes Zoster Vaccine 1437173A Different formulations of investigational vaccine (GSK 1437173A) administered in 2 or 3 doses intramuscularly.
Experimental: Group B	Biological: Herpes Zoster Vaccine 1437173A Different formulations of investigational vaccine (GSK 1437173A) administered in 2 or 3 doses intramuscularly.
Experimental: Group C	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.
Placebo Comparator: Group D	Biological: Placebo vaccine (saline) 1 or 3 doses of Placebo (saline) injected intramuscularly.

Detailed Description:

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

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920218

Locations

United States, California
GSK Investigational Site
Duarte, California, United States, 91010
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02115
United States, Minnesota
GSK Investigational Site
Minnesota, Minnesota, United States, 55455
GSK Investigational Site
Rochester, Minnesota, United States, 55905
United States, New York
GSK Investigational Site
New York, New York, United States, 10065
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27514
GSK Investigational Site
Durham, North Carolina, United States, 27705
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104

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:	NCT00920218 History of Changes
Other Study ID Numbers:	110258
Study First Received:	June 12, 2009
Last Updated:	June 9, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Vaccine
Safety
Herpes Zoster
Immunogenicity
Stem cell transplantation

Additional relevant MeSH terms:

Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013