Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine When Administered Under the Skin (Subcutaneously) vs. Into a Muscle (Intramuscularly) in Adults 50 Years of Age and Older

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01777321
First received: January 24, 2013
Last updated: December 5, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of GSK Biologicals' Herpes Zoster (HZ) vaccine (GSK 1437173A) when administered subcutaneously (SC) as compared to intramuscularly (IM) to people 50 years of age and older.


Condition Intervention Phase
Herpes Zoster
Biological: Herpes zoster vaccine GSK1437173A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A When Administered Subcutaneously vs. Intramuscularly in Adults Aged ≥50 Years

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Evaluation of gE-specific antibody concentrations [ Time Frame: At one month post-vaccination 2 (Month 3) ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: Within 7 days (Days 0-6) after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: Within 30 days (Days 0-29) after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events (SAEs) [ Time Frame: From Month 0 (vaccination 1) up to Month 3 (30 days post-vaccination 2) ] [ Designated as safety issue: No ]
  • Occurrence of adverse events (AEs) of specific interest [Potential Immune-Mediated Disease (pIMDs)] [ Time Frame: From Month 0 (vaccination 1) up to Month 3 (30 days post-vaccination 2) ] [ Designated as safety issue: No ]
    In all subjects


Secondary Outcome Measures:
  • Evaluation of gE-specific antibody concentrations [ Time Frame: Month 0 (prior to vaccination 1), Month 2 (2 months post-vaccination 1), Month 3 (one month post-vaccination 2) and Month 14 (12 months post-vaccination 2) ] [ Designated as safety issue: No ]
    Evaluated in all subjects and for each cohort: Japanese and non-Japanese Ethnic Origin (JEOc and NJEOc)

  • Evaluation of gE-specific antibody concentrations [ Time Frame: Month 2 (2 months post-vaccination 1), Month 3 (one month post-vaccination 2) and Month 14 (12 months post-vaccination 2) ] [ Designated as safety issue: No ]
    Evaluated in all subjects and for each cohort: JEOc and NJEOc

  • Evaluation of gE-specific CD4+ T-cell mediated immunogenicity [ Time Frame: Month 0 (prior to vaccination 1), Month 3 (one month post-vaccination 2) and Month 14 (12 months post-vaccination 2) ] [ Designated as safety issue: No ]
    Evaluated in the entire CMI subcohort and in the portion of the CMI subcohort within the JEOc and NJEOc

  • Evaluation of gE-specific CD4+ T-cell mediated immunogenicity [ Time Frame: Month 3 (one month post-vaccination 2) and Month 14 (12 months post-vaccination 2) ] [ Designated as safety issue: No ]
    Evaluated in the entire CMI subcohort and in the portion of the CMI subcohort within the JEOc and NJEOc

  • Occurrence of solicited local and general symptoms [ Time Frame: Within 7 days (Days 0-6) after each vaccination ] [ Designated as safety issue: No ]
    Evaluated for each cohort: JEOc and NJEOc

  • Occurrence of unsolicited symptoms (AEs) [ Time Frame: Within 30 days (Days 0-29) after each vaccination, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification ] [ Designated as safety issue: No ]
    Evaluated for each cohort: JEOc and NJEOc

  • Occurrence of SAEs [ Time Frame: From Month 0 (vaccination 1) up to Month 3 (30 days post-vaccination 2) ] [ Designated as safety issue: No ]
    Evaluated for each cohort: JEOc and NJEOc

  • Occurrence of AEs of specific interest (pIMDs) [ Time Frame: From Month 0 (vaccination 1) up to Month 3 (30 days post-vaccination 2) ] [ Designated as safety issue: No ]
    Evaluated for each cohort: JEOc and NJEOc

  • Occurrence of SAEs [ Time Frame: From Month 3 (30 days post-vaccination 2) up to Month 14 (12 months post-vaccination 2) ] [ Designated as safety issue: No ]
    Evaluated for all subjects and each cohort: JEOc and NJEOc

  • Occurrence of AEs of specific interest (pIMDs) [ Time Frame: From Month 3 (30 days post-vaccination 2) up to Month 14 (12 months post-vaccination 2) ] [ Designated as safety issue: No ]
    Evaluated for all subjects and each cohort: JEOc and NJEOc


Enrollment: 60
Study Start Date: June 2013
Estimated Study Completion Date: October 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SC HZ/su Group
Subjects will receive HZ/su vaccine administered SC on a 0,2-month schedule.
Biological: Herpes zoster vaccine GSK1437173A
HZ/su vaccine administered either into the subcutaneous tissue of the upper arm (deltoid region) of the non-dominant arm or intramuscularly in the deltoid region of non-dominant arm on a 0,2-month schedule.
Active Comparator: IM HZ/su Group
Subjects will receive HZ/su vaccine administered IM on a 0,2-month schedule.
Biological: Herpes zoster vaccine GSK1437173A
HZ/su vaccine administered either into the subcutaneous tissue of the upper arm (deltoid region) of the non-dominant arm or intramuscularly in the deltoid region of non-dominant arm on a 0,2-month schedule.

Detailed Description:

There are 2 treatment groups in this study based upon the mode of vaccine administration. Each treatment group has 2 subcohorts each:

  • Cohort of subjects of Japanese Ethnic Origin (JEOc)
  • Cohort of subjects not of Japanese Ethnic Origin (NJEOc)

The humoral immunogenicity (HI) will be measured in all subjects. A subset of subjects will be enrolled in the Cell-Mediated Immunogenicity (CMI) sub cohort.

  Eligibility

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

Inclusion Criteria:

  • Subject who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Subject, if residing in Japan, is of Japanese ethnic origin, defined as having been born in Japan with four ethnic Japanese grandparents and able to speak Japanese.
  • Subject, if not residing in Japan, may be of any ethnic origin.
  • Subject has provided written informed consent.
  • Subject, male or female, who is 50 YOA or older at the time of the first vaccination.
  • Subject, if female, of non-childbearing potential may be enrolled in the study.
  • Subject, if female, of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, 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 2 months after completion of the vaccination series (i.e., for 2 months after Month 2).
  • Exclusion Criteria:
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Concurrently participating or planned participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Administration or planned administration of a live vaccine within 30 days prior to the first study vaccination through 30 days after the second study vaccination.
  • Administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine.
  • Planned administration, during the study, of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
  • Administration of immunoglobulins and/or any blood products within the three (3) months preceding the first dose of study vaccine or planned administration during the study period.
  • Chronic administration (defined as >14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

    • For corticosteroids, a prednisone dose of <20 mg/day, or equivalent, is allowed.
    • Inhaled, topical, and intra-articular corticosteroids are allowed.
  • Administration or planned administration of long-acting immune-modifying drugs (e.g., infliximab) within six months prior to the first vaccine dose through the duration of the study period.
  • History of HZ.
  • Previous vaccination against HZ or varicella (registered or investigational product).
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study material and equipment.
  • Significant underlying illness that, in the opinion of the investigator, would be expected to prevent completion of the study.
  • Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
  • Acute disease and/or fever at the time of vaccination:

    • Fever is defined as temperature ≥37.5°C (99.5°F) for oral, axillary, or tympanic route, or ≥38.0°C/100.4°F for rectal route. The preferred route for recording temperature in this study will be oral.
    • Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) through Month 4 (i.e., 2 months after the second dose of study vaccine).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777321

Locations
Japan
GSK Investigational Site
Fukuoka, Japan, 812-0025
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01777321     History of Changes
Other Study ID Numbers: 116760, 2012-005671-14
Study First Received: January 24, 2013
Last Updated: December 5, 2013
Health Authority: United States: Food and Drug Administration
Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Herpes Zoster
Intramuscular
Subcutaneous
Safety
≥50 years of age
Adults
Immunogenicity
Elderly

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

ClinicalTrials.gov processed this record on April 17, 2014