Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A in Adults With a Prior Episode of Herpes Zoster

Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults With a Prior Episode of Herpes Zoster

The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in subjects' ≥ 50 years of age (YOA) who previously have had Herpes Zoster (HZ). The data collected will be compared with the data from subjects without HZ in other HZ/su trials.

Study Overview

• Status: Completed
• Conditions: Herpes Zoster
• Intervention / Treatment: Biological: Herpes Zoster vaccine (GSK1437173A)

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Coquitlam, British Columbia, Canada, V3K 3P4
      • GSK Investigational Site
  • Quebec
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • GSK Investigational Site
• Russian Federation
  • Barnaul, Russian Federation, 656056
    • GSK Investigational Site
  • Ekaterinburg, Russian Federation, 620137
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects with a physician-documented history of HZ.
• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• A male or female aged 50 years or older at the time of the first vaccination.
• Written informed consent obtained from the subject.

• Female subjects of non-childbearing potential may be enrolled in the study.

  • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.

• Female subjects 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.

Exclusion Criteria:

• Active Herpes Zoster infection (a case is considered no more active when all lesions have at least turned to crusts).
• Use of any investigational or non-registered product other than the study vaccine/product within 30 days preceding the first dose of study vaccine/product, or planned use 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 of long-acting immune-modifying drugs within six months prior to the first vaccine dose or expected administration at any time during the study period.
• 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.
• Concurrently participating 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 vaccine/product.
• Previous vaccination against VZV or HZ and/or planned administration during the study of an HZ vaccine other than the study vaccine.
• Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/product.

• Acute disease and/or fever at the time of enrolment.

  • Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C /100.4°F on 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.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
• Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions before Month 4 (i.e. 2 months after the last dose of study vaccine).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HZ Group; Subjects will receive 2 doses of the HZ/su vaccine at Month 0 and Month 2.	Biological: Herpes Zoster vaccine (GSK1437173A); 2 doses administered intramuscularly in deltoid region of non-dominant arm.; Other Names: HZ/su vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Vaccine Responders for Anti-gE Antibodies as Determined by ELISA	Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for anti-gE [4x97 milli-international units per milliliter (mIU/mL)]; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.	At Month 3
Number of Subjects With Any and Grade 3 Solicited Local Symptoms	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.	Within 7 days (Day 0-6) after each vaccine dose and across doses
Number of Days With Solicited Local Symptoms	The number of days with any local symptoms during the solicited post-vaccination period.	Within 7 days (Day 0-6) after each vaccine dose
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral 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 temperature = temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.	Within 7 days (Day 0-6) after each vaccine dose and across doses
Number of Days With Solicited General Symptoms	The number of days with general symptoms during the solicited post-vaccination period.	Within 7 days (Day 0-6) after each vaccine dose
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	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.	Within 30 days (Days 0-29) after each vaccination
Number of Subjects With Any Serious Adverse Events (SAEs)	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.	From first vaccination up to 30 days post last vaccination
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)	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.	From first vaccination up to 30 days post last vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-gE Antibody Concentrations	Anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The outcome was assessed in each of the following age ranges: 50-59 YOA, 60-69 YOA and ≥ 70 YOA, in terms of antibody concentrations.	At Month 0 and at Month 3
Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value	The cut-off value was 97 mIU/mL.	At Month 0 and at Month 3
Number of Subjects With SAEs	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.	Starting after 30 days post last vaccination until study end (i.e. Month 14)
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)	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.	Starting after 30 days post last vaccination until study end (i.e. Month 14)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Godeaux O, Kovac M, Shu D, Grupping K, Campora L, Douha M, Heineman TC, Lal H. Immunogenicity and safety of an adjuvanted herpes zoster subunit candidate vaccine in adults >/= 50 years of age with a prior history of herpes zoster: A phase III, non-randomized, open-label clinical trial. Hum Vaccin Immunother. 2017 May 4;13(5):1051-1058. doi: 10.1080/21645515.2016.1265715. Epub 2017 Jan 9.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: June 10, 2013
• Primary Completion (Actual): February 10, 2014
• Study Completion (Actual): November 25, 2014

Study Registration Dates

• First Submitted: March 28, 2013
• First Submitted That Met QC Criteria: April 5, 2013
• First Posted (Estimate): April 10, 2013

Study Record Updates

• Last Update Posted (Actual): October 18, 2018
• Last Update Submitted That Met QC Criteria: September 20, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Safety; Adults; Immunogenicity; Zoster
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Herpes Simplex; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 116796; 2012-003643-30 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.

Study Data/Documents

1. Informed Consent Form
   Information identifier: 116796
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Dataset Specification
   Information identifier: 116796
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Study Protocol
   Information identifier: 116796
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Statistical Analysis Plan
   Information identifier: 116796
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Individual Participant Data Set
   Information identifier: 116796
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Clinical Study Report
   Information identifier: 116796
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Annotated Case Report Form
   Information identifier: 116796
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No