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

NCT ID: NCT01827839

Last Updated: 2018-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-10
• Study Completion Date: 2014-11-25

Brief Summary

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.

Conditions

Herpes Zoster

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HZ Group

Subjects will receive 2 doses of the HZ/su vaccine at Month 0 and Month 2.

Group Type: EXPERIMENTAL

Herpes Zoster vaccine (GSK1437173A)

Intervention Type: BIOLOGICAL

2 doses administered intramuscularly in deltoid region of non-dominant arm.

Interventions

Herpes Zoster vaccine (GSK1437173A)

2 doses administered intramuscularly in deltoid region of non-dominant arm.

Intervention Type: BIOLOGICAL

Other Intervention Names

HZ/su vaccine

Eligibility Criteria

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).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Coquitlam, British Columbia, Canada

GSK Investigational Site

Pointe-Claire, Quebec, Canada

GSK Investigational Site

Barnaul, , Russia

GSK Investigational Site

Yekaterinburg, , Russia

Countries

Canada; Russia

References

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.

Reference Type: DERIVED

PMID: 28068212 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

2012-003643-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

116796

Identifier Type: -

Identifier Source: org_study_id