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Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations in Adults >= 50 Years

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00802464
First received: December 4, 2008
Last updated: October 21, 2010
Last verified: October 2010
  Purpose

The goal of this randomized observer-blind trial is to further refine the formulation of vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune responses and the safety profiles of the different formulations.


Condition Intervention Phase
Herpes Zoster
Herpes Zoster Vaccine
Biological: Herpes zoster vaccine GSK1437173A
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of Different Formulations of GSK Biologicals' Herpes Zoster Vaccine 1437173A When Administered Twice in Adults Aged 50 Years and Older

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Cell mediated immune response (CMI) in terms of frequencies of CD4 T cells specific for VZV antigens [ Time Frame: 1 month after second vaccination ] [ Designated as safety issue: No ]
  • VZV-specific Ab concentrations [ Time Frame: 1 month after second vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cell-mediated immunity (CMI) in terms of frequencies of CD4 T cells specific for varicella-zoster virus (VZV) antigens [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
  • CMI in terms of frequencies of CD8 T cells specific for VZV antigens [ Time Frame: Months 0, 2 and 3 ] [ Designated as safety issue: No ]
  • VZV-specific Ab concentrations [ Time Frame: Months 0 and 2 ] [ Designated as safety issue: No ]
  • Occurrence, intensity and relationship to vaccination of solicited adverse events (AEs) [ Time Frame: Days 0-6 after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence, intensity and relationship to vaccination of unsolicited AEs [ Time Frame: Days 0 to 29 after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence and relationship to vaccination of all serious AEs (SAEs) [ Time Frame: From Month 0 until 12 months following the last vaccination (Month 14) ] [ Designated as safety issue: No ]
  • Occurrence and relationship to vaccination of all of all new onsets of autoimmune diseases (NOADs) [ Time Frame: from Month 0 until 12 months following the last vaccination (Month 14) ] [ Designated as safety issue: No ]
  • Occurrence of suspected cases of Herpes Zoster (HZ) [ Time Frame: from Month 0 until 12 months following the last vaccination (Month 14) ] [ Designated as safety issue: No ]
  • Haematological (complete blood count e.g. red blood cells, white blood cells and haemoglobin) and biochemical (e.g. creatine, liver enzymes and total protein) parameters Month 0 [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
  • Haematological (complete blood count e.g. red blood cells, white blood cells and haemoglobin) and biochemical (e.g. creatine, liver enzymes and total protein) parameters Month 2 [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
  • Haematological (complete blood count e.g. red blood cells, white blood cells and haemoglobin) and biochemical (e.g. creatine, liver enzymes and total protein) parameters Month 3 [ Time Frame: Minth 3 ] [ Designated as safety issue: No ]

Enrollment: 410
Study Start Date: January 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Formulation 1
Biological: Herpes zoster vaccine GSK1437173A
2 vaccinations at Months 0 and 2 with GSK1437173A (different formulations)
Experimental: Group B
Formulation 2
Biological: Herpes zoster vaccine GSK1437173A
2 vaccinations at Months 0 and 2 with GSK1437173A (different formulations)
Placebo Comparator: Group D
Placebo
Biological: Placebo
2 vaccinations at Months 0 and 2 with placebo
Experimental: Group C
Formulation 3
Biological: Herpes zoster vaccine GSK1437173A
2 vaccinations at Months 0 and 2 with GSK1437173A (different formulations)

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female 50 years of age or above at the time of the first vaccination;
  • Written informed consent obtained from the subject;
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study;
  • 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 or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;
  • Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before the first study vaccination or scheduled within 30 days after study vaccination;
  • Previous vaccination against HZ;
  • Previous vaccination against varicella;
  • History of HZ;
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy;
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period;
  • Acute disease at the time of enrolment.
  • Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study;
  • History of or current drug and/or alcohol abuse;
  • Pregnant or lactating female;
  • Female planning to become pregnant or planning to discontinue contraceptive precautions if of childbearing potential.
  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: NCT00802464

Locations
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85020
United States, Florida
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89130
United States, New Jersey
GSK Investigational Site
Edison, New Jersey, United States, 08817
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44122
United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
Czech Republic
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
Spain
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Mahadahonda( Madrid, Spain, 28222
GSK Investigational Site
Marid, Spain, 28040
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00802464     History of Changes
Other Study ID Numbers: 112077
Study First Received: December 4, 2008
Last Updated: October 21, 2010
Health Authority: Czech Republic: Státní ústav pro kontrolu léčiv, Oddělení klinického hodnocení
Spain: Agencia Española del Medicamento y Productos Sanitarios
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Cytokine
Vaccine
Herpes Zoster (HZ)
Cell mediated immunity (CMI)
Antibody response
Varicella Zoster Virus (VZV)
Shingles

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

ClinicalTrials.gov processed this record on November 27, 2014