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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:
ClinicalTrials.gov Identifier:
NCT00802464
First Posted: December 5, 2008
Last Update Posted: December 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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 Biological: Herpes zoster vaccine GSK1437173A Biological: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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:
  • Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers [ Time Frame: One month after the second vaccination (Month 3) ]
    The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).

  • Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers [ Time Frame: One month after the second vaccination (Month 3) ]
    The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).

  • Anti-glycoprotein E (gE) Antibody Concentrations [ Time Frame: One month after the second vaccination (Month 3) ]
    Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

  • Anti-VZV Antibody Concentrations [ Time Frame: One month after the second vaccination (Month 3) ]
    Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).


Secondary Outcome Measures:
  • Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers [ Time Frame: At Month 0 and at Month 2 ]
    The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).

  • Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers [ Time Frame: At Month 0 and at Month 2 ]
    The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).

  • Anti-gE Antibody Concentrations [ Time Frame: At Month 0 and at Month 2 ]
    Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

  • Anti-VZV Antibody Concentrations [ Time Frame: At Month 0 and at Month 2 ]
    Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period after each dose and across doses ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. [ Time Frame: During the 7-day (Days 0-6)post-vaccination period after each dose and across doses ]
    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

  • Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: Within the 30-day (Days 0-29) post-vaccination period ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From Month 0 up to Month 8 ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the period after Month 8 up to the end of the study at Month 14 ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  • Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) [ Time Frame: From Month 0 until Month 8 ]
    Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.

  • Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) [ Time Frame: During the period after Month 8 up to the end of the study at Month 14 ]
    Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.

  • Number of Subjects With Suspected Cases of Herpes Zoster (HZ) [ Time Frame: From Month 0 until Month 8 ]
    A suspected case of HZ was defined as a rash consistent with HZ.

  • Number of Subjects With Suspected Cases of Herpes Zoster (HZ) [ Time Frame: During the period after Month 8 up to the end of the study at Month 14 ]
    A suspected case of HZ is defined as a rash consistent with HZ.

  • Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges [ Time Frame: At Month 0 ]
    Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).

  • Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges [ Time Frame: At Month 2 ]
    Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).

  • Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges [ Time Frame: At Month 3 ]
    Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).


Enrollment: 410
Actual Study Start Date: January 12, 2009
Study Completion Date: July 2, 2010
Primary Completion Date: July 2, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK1437173A formulation 1 Group
Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.
Biological: Herpes zoster vaccine GSK1437173A
2 vaccinations at Months 0 and 2 with GSK1437173A (different formulations)
Other Names:
  • gE/AS01E
  • gE/AS01B
Experimental: GSK1437173A formulation 2 Group
Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) GSK1437173A formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.
Biological: Herpes zoster vaccine GSK1437173A
2 vaccinations at Months 0 and 2 with GSK1437173A (different formulations)
Other Names:
  • gE/AS01E
  • gE/AS01B
Experimental: GSK1437173A formulation 3 Group
Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.
Biological: Herpes zoster vaccine GSK1437173A
2 vaccinations at Months 0 and 2 with GSK1437173A (different formulations)
Other Names:
  • gE/AS01E
  • gE/AS01B
Placebo Comparator: Control Group
Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.
Biological: Placebo
2 vaccinations at Months 0 and 2 with placebo
Other Name: Placebo/Saline

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Pittsburg, Pennsylvania, United States, 15236
Czechia
GSK Investigational Site
Hradec Kralove, Czechia, 500 01
Spain
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Barcelona, Spain
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

Additional Information:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 112077
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 112077
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 112077
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 112077
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 112077
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 112077
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 112077
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00802464     History of Changes
Other Study ID Numbers: 112077
First Submitted: December 4, 2008
First Posted: December 5, 2008
Results First Submitted: August 10, 2017
Results First Posted: December 12, 2017
Last Update Posted: December 12, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://

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
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs