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Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine at 9 and 10 Years After Vaccine Administration and Assessment of Re-vaccination With 2 Additional Doses at 10 Years After Initial Vaccination, in Healthy Subjects Aged 60 Years of Age(YOA) and Older

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ClinicalTrials.gov Identifier: NCT02735915
Recruitment Status : Active, not recruiting
First Posted : April 13, 2016
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to evaluate the persistence of immune response to the HZ vaccine as well as safety up to 10 years after the first dose of initial vaccination course. This study will also assess immune responses after re-vaccination with 2 additional doses of the HZ/su administered at ten years after first dose of initial vaccination course from study Zoster-003 (NCT00434577).

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

Detailed Description:

In this LTFU study (ZOSTER-060), subjects who received 2 doses of HZ/su in the earlier Zoster-003 (NCT00434577) study will be followed up at Month 108/Year 9 and Month 120/Year 10 post first dose of vaccine for safety and immunogenicity (humoral and cellular). In order to assess the effect of re-vaccination with 2 additional doses of HZ/su vaccine, all the subjects will receive 2 additional doses of the HZ/su vaccine, on a 0, 2-month schedule at ten years after the initial vaccination course in study Zoster-003 (NCT00434577), and will be followed for reactogenicity, safety and humoral and cellular immunogenicity (including persistence).

In alignment with the previous persistence timepoints, this study has no control group.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Long Term Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine 1437173A and Assessment of Re-vaccination With 2 Additional Doses, in Healthy Subjects Aged 60 Years of Age and Older
Actual Study Start Date : April 11, 2016
Actual Primary Completion Date : August 28, 2017
Estimated Study Completion Date : November 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
Experimental: Zoster vaccine Group
Subjects will receive Herpes Zoster Vaccine GSK1437173A according to a 0, 2-month schedule.
Biological: Herpes Zoster Vaccine GSK1437173A
Intramuscular injection
Other Name: HZ/su




Primary Outcome Measures :
  1. Antigen-specific antibody (Ab) concentrations. [ Time Frame: At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577). ]
    Anti-glycoprotein E (gE) Ab concentrations as determined by enzyme-linked immunosorbent assay (ELISA).

  2. Antigen-specific antibody (Ab) concentrations. [ Time Frame: At Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577). ]
    Anti-gE Ab concentrations as determined by ELISA.

  3. Frequencies of antigen-specific CD4 T-cells. [ Time Frame: At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577). ]
  4. Frequencies of antigen-specific CD4 T-cells. [ Time Frame: At Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577). ]

Secondary Outcome Measures :
  1. Antigen-specific antibody (Ab) concentrations. [ Time Frame: At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577). ]
    Anti-gE Ab concentrations as determined by ELISA within each age cohort (60-69 YOA and ≥70 YOA at the time of initial vaccination).

  2. Frequencies of antigen-specific CD4 T-cells. [ Time Frame: At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577). ]
  3. Number of subjects with any serious adverse events (SAEs) related to study participation or to a concurrent GSK medication/vaccine (including HZ/su administered during the Zoster-003 (NCT00434577) study). [ Time Frame: Between Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577). ]
    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.

  4. Antigen-specific antibody (Ab) concentrations post re-vaccination. [ Time Frame: At 1 month post each vaccination dose, and at 12 months after the last vaccination dose in current study (corresponding to 121, 123 and 134 months post first dose of initial vaccination course in study Zoster-003 (NCT00434577)). ]
    Anti-gE antibody concentrations as determined by ELISA in all subjects.

  5. Frequencies of antigen-specific CD4 T-cells. [ Time Frame: At 1 month post each vaccination dose, and at 12 months after the last vaccination dose in current study (corresponding to 121, 123 and 134 months post first dose of initial vaccination course in study Zoster-003 (NCT00434577)). ]
  6. Number of subjects with any, Grade 3 and related solicited local symptoms [ Time Frame: Within 7 days (Days 0-6) after each vaccination in the current study. ]
  7. Number of subjects with any, Grade 3 and related solicited general symptoms [ Time Frame: Within 7 days (Days 0-6) after each vaccination in the current study. ]
  8. Number of subjects with any, Grade 3 and related unsolicited AEs according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects. [ Time Frame: During 30 days (Days 0-29) after each vaccination in the current study. ]
    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 is 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.

  9. Number of subjects with any and related SAEs. [ Time Frame: From Dose 1 of re-vaccination until study end at 14 months after the last dose of the vaccination in the current study. ]
    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.

  10. Number of subjects with any fatal SAEs. [ Time Frame: From Dose 1 of re-vaccination until study end at 14 months after the last dose of the vaccination in the current study. ]
    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.

  11. Number of subjects with any and related potential immune-mediated diseases (pIMDs). [ Time Frame: From Dose 1 of re-vaccination until study end at 14 months after the last dose of the vaccination in the current study. ]
    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



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Ages Eligible for Study:   68 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, ability to have scheduled contacts to allow evaluation during the study). Or subjects with a caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, vaccination visits, availability for follow-up contacts).
  • Written informed consent obtained from the subject prior to performance of any study specific procedure.
  • Previous participation in study ZOSTER-003 (NCT00434577), in group 50 µg gE / AS01B, and who completed the vaccination course (2 doses of HZ/su) in study ZOSTER-003 (NCT00434577).
  • Subjects are expected to enter the study (or complete Visit 1) as of the time they turn 108 months after first vaccination of previous vaccination course with HZ/su and not later than 111 months.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the first study visit (Day -29 to Day 0), or planned use during the study period.
  • Use or anticipated use of immunosuppressants or immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of corticosteroids (>14 consecutive days of prednisone at a dose of ≥20 mg/day [or equivalent]), long-acting immune-modifying agents (e.g., infliximab) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus [HIV] infection).
  • Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine* within 8 days prior to or within 14 days after either dose of study vaccine.

E.g., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines and pneumococcal conjugate vaccines.

  • Previous vaccination against HZ since initial vaccination in Zoster-003.
  • Administration of immunoglobulins and/or any blood products during the period starting 3 months before the study start, or planned administration during the study period.
  • History of previous HZ.

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): NCT02735915


Locations
Czechia
GSK Investigational Site
Hradec Kralove, Czechia
Germany
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
GSK Investigational Site
Berlin, Germany, 13347
Sweden
GSK Investigational Site
Eskilstuna, Sweden, SE-631 88
GSK Investigational Site
Uppsala, Sweden, SE-751 85
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02735915     History of Changes
Other Study ID Numbers: 204926
2015-004400-30 ( EudraCT Number )
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Keywords provided by GlaxoSmithKline:
Immunogenicity
Safety
Long term follow-up
Adults
Herpes zoster

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs