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Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A

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ClinicalTrials.gov Identifier: NCT01610414
Recruitment Status : Completed
First Posted : June 4, 2012
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant recipients 18 years of age and older. To this end, the study will evaluate vaccine efficacy (VE) of the GSK1437173A vaccine, administered on a 2-dose schedule, compared to placebo in reducing the risk of developing HZ in this population.

Condition or disease Intervention/treatment Phase
Herpes Zoster Biological: Herpes Zoster vaccine GSK1437173A Biological: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1877 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Observer-blind Study to Evaluate Efficacy, Safety, and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A
Actual Study Start Date : July 13, 2012
Actual Primary Completion Date : November 4, 2016
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles

Arms and Interventions
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Arm Intervention/treatment
Experimental: GSK1437173A Group
Subjects received 2 doses of the candidate HZ vaccine GSK 1437173A, administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 1 Month schedule.
 Biological: Herpes Zoster vaccine GSK1437173A
2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm
Placebo Comparator: Placebo Group
Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 1 Month schedule.
 Biological: Placebo
2 doses administered IM in deltoid region of non-dominant arm


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects With Confirmed Herpes Zoster (HZ) Episode [ Time Frame: From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months) ]

    A suspected case of HZ was defined as (1) a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations), or a vesicular rash suggestive of VZV infection regardless of the distribution, and no alternative diagnosis; or (2) a clinical presentation (symptoms and/or signs) and specific laboratory findings* suggestive of VZV infection in the absence of characteristic HZ or VZV rash.

    A suspected case of HZ was confirmed either: by Polymerase Chain Reaction (PCR) or by the HZ Ascertainment Committee (HZAC), consisting of physicians with HZ expertise.



Secondary Outcome Measures :
  1. Duration of 'Worst' HZ-associated Pain [ Time Frame: From Month 0 until study end (4 years approximately), from the onset of a confirmed HZ rash over the entire pain reporting period ]
    Duration of HZ-associated pain rated as 3 or greater on the 'worst pain' Zoster Brief Pain Inventory (ZBPI) question, following the onset of a confirmed HZ rash over the entire pain reporting period in subjects with confirmed HZ; presented as T (day) [=the sum of follow-up period (for subjects without severe worst pain T is 1, for subjects with severe worst pain T is the duration of severe worst pain) expressed in days].

  2. Number of Subjects With Confirmed HZ-associated Complications [ Time Frame: From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months) ]
    This analysis excluded complications that were linked to a confirmed HZ case that occurred after the start of the relapse treatment.

  3. Number of Subjects With Postherpetic Neuralgia (PHN) [ Time Frame: From Month 0 until study end (21 months median follow-up) ]
    This analysis excluded PHN episodes that were linked to a confirmed HZ case that occurred after the start of the relapse treatment.

  4. Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects [ Time Frame: At Months 0, 1, 2, 13 and 25 ]
    Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU/mL.

  5. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following 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.

  6. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary/tympanic temperature equal to or above 37.5 degrees Celsius (°C) or rectal temperature equal to or above 38.0 °C]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

  7. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: During 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.

  8. Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) [ Time Frame: From Month 0 up to 365 days post last vaccination ]
    Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

  9. Number of Subjects With Any Relapse [ Time Frame: From Month 0 until study end (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years) ]
    Relapse was defined as the occurrence of the underlying malignancy or disease for which the HCT was undertaken.

  10. Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEs to GSK Study Vaccine/Placebo [ Time Frame: From Month 0 until 365 days post last vaccination (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years) ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. This enpoint also presents SAES related to the GSK study vaccine/placebo.

  11. Number of Subjects With Fatal SAEs and SAEs Related to Study Participation or to a GSK Concomitant Medication or Vaccination [ Time Frame: From the Pre-vaccination visit (Up to 110 days prior Month 0) until study end (approximate median of 29 months follow-up minimum 1 year and maximum 4 years) ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. This endpoint presents fatal SAEs and SAEs related to study participation or to a concurrent GSK medication/vaccine.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Study entry (enrollment) occurs at the Pre-vaccination visit.

  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • A male or female aged 18 years or older at the time of study entry.
  • Has undergone or will undergo autologous HCT within 50-70 days prior to the first vaccination with the study vaccine/placebo, and there are no plans for additional HCTs.
  • Female subjects of non-childbearing potential may be enrolled in the study. For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.

OR Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination with the study vaccine/placebo, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 12 months after completion of the vaccination series (i.e., until Month 13).

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. However, the investigational use of a registered or non-registered product to treat the subject's underlying disease for which the HCT was undertaken, or a complication of the underlying disease, is allowed.
  • Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo.
  • Planned administration during the study of a HZ vaccine other than the study vaccine.
  • Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or study material and equipment.
  • Prophylactic antiviral therapy with activity against Varicella Zoster Virus (VZV) expected to last more than 6 months after transplantation.
  • Administration and/or planned administration of a vaccine not foreseen by the study protocol between HCT and 30 days after the last dose of study vaccine/placebo. However, licensed non-replicating vaccines may be administered up to 8 days prior to dose 1and/or 2, and/or at least 14 days after any dose of study vaccine/placebo.
  • HIV infection by clinical history.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 13 (i.e., one year after the last dose of study vaccine/placebo).
Contacts and Locations
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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): NCT01610414


Locations
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Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01610414    
Other Study ID Numbers: 115523
2012-000138-20 ( EudraCT Number )
First Posted: June 4, 2012    Key Record Dates
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018
Last Verified: December 2017
Keywords provided by GlaxoSmithKline:
Observer-blind
Efficacy
Immunogenicity
Vaccination
 Safety
Adult autologous haematopoietic cell transplant recipients
Herpes Zoster
Additional relevant MeSH terms:
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Herpes Simplex
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
 Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Varicella Zoster Virus Infection