Safety and Immunogenicity of the Zoster Vaccine GSK1437173A in Elderly Subjects - Full Text View

Purpose

Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II study will be subdivided into a primary study (108494) and three extension studies (108516, 108518 & 108520), consisting of one additional visit each at months 12, 24 and 36, respectively, from the first visit of the Zoster-003 primary study onwards. The aim of the primary 108494 study is to evaluate the immunogenicity & safety of different dosages of the GSK1437173A vaccine in healthy elderly population. The study population will be stratified by age. The primary objective of this trial is to select the best dosage of GSK1437173A. The aim of the extension studies is to evaluate the persistence of the immune response induced by the candidate HZ vaccine during a long term period.

No new subjects will be enrolled during the extension phases of the study.

Condition	Intervention	Phase
Herpes Zoster (Shingles) Shingles	Biological: Herpes Zoster vaccine GSK1437173A Biological: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Official Title:	A Vaccination Study to Evaluate the Safety and Immune Response of the GSK Biologicals Zoster Vaccine, GSK1437173A, and to Compare 3 Dosages of GSK1437173A in Healthy Elderly Subjects, Aged 60 Years and Above

Resource links provided by NLM:

MedlinePlus related topics: Shingles

Drug Information available for: Herpes Zoster Vaccine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Cell mediated immune response (CMI) in terms of frequencies of CD4 T cells specific for VZV antigens [ Time Frame: One month after the second vaccination (Month 3). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CMI in terms of frequencies of CD4/CD8 T cells specific for VZV antigens [ Time Frame: At months 0, 2, 3, 12, 24 and 36. ] [ Designated as safety issue: No ]
VZV-specific Ab concentrations [ Time Frame: At months 0, 2, 3, 12, 24 and 36. ] [ Designated as safety issue: No ]
Frequency of VZV-specific memory B-cells in a subset of subjects [ Time Frame: At months 0 and 3. ] [ Designated as safety issue: No ]
Occurrence, intensity and relationship to vaccination of solicited local and general AEs. [ Time Frame: During 7 days after each vaccination. ] [ Designated as safety issue: No ]
Occurrence, intensity and relationship to vaccination of unsolicited AEs. [ Time Frame: During 30 days after each vaccination. ] [ Designated as safety issue: No ]
Occurrence and relationship to vaccination of all SAEs. [ Time Frame: During the whole study period (day 0 to month 36) ] [ Designated as safety issue: No ]
Occurrence of clinically diagnosed HZ episodes during the whole study period. [ Time Frame: Day 0 to month 36 ] [ Designated as safety issue: No ]
Haematological and biochemical parameters. [ Time Frame: At months 0, 2 and 3. ] [ Designated as safety issue: No ]
Biochemical parameters [ Time Frame: 1 week after each vaccination. ] [ Designated as safety issue: No ]

Enrollment:	715
Study Start Date:	February 2007
Study Completion Date:	July 2010
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Group A Modified formulation of GSK1437173A vaccine (1st dose) followed by placebo (2nd dose).	Biological: Herpes Zoster vaccine GSK1437173A Single or two-dose intramuscular injection. Biological: Placebo Single intramuscular injection
Experimental: Group B Two doses of GSK1437173A low dose.	Biological: Herpes Zoster vaccine GSK1437173A Single or two-dose intramuscular injection.
Experimental: Group C Two doses of GSK1437173A medium dose.	Biological: Herpes Zoster vaccine GSK1437173A Single or two-dose intramuscular injection.
Experimental: Group D Two doses of GSK1437173A high dose.	Biological: Herpes Zoster vaccine GSK1437173A Single or two-dose intramuscular injection.
Placebo Comparator: Group E Placebo (1st dose) followed by GSK1437173A high dose (2nd dose).	Biological: Herpes Zoster vaccine GSK1437173A Single or two-dose intramuscular injection. Biological: Placebo Single intramuscular injection

Detailed Description:

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
A male or female aged 60 years or older at the time of the first vaccination.
Written informed consent obtained from the subject

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first injection with study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period, except inhaled and topical steroids are allowed.
Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks of the first study vaccine injection, with the exception of the influenza vaccine, which can be administered 1 week preceding or 1 month after the first study vaccine injection.
Previous vaccination against HZ.
History of herpes zoster (Shingles).
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Acute disease at the time of enrolment.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by subject's medical history or physical examination as assessed by the investigator.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period.
History of or current drug and/or alcohol abuse.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434577

Locations

Czech Republic
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
Germany
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
GSK Investigational Site
Berlin, Germany, 13347
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1018 WT
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

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00434577 History of Changes
Other Study ID Numbers:	108494, 108516, 108518, 108520
Study First Received:	February 12, 2007
Last Updated:	March 22, 2012
Health Authority:	Germany: Paul-Ehrlich-Institut Sweden: Medical Products Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Czech Republic: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:

GSK Biologicals
Herpes Zoster (HZ)
Vaccine
Varicella Zoster Virus (VZV)
Shingles

Additional relevant MeSH terms:

Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013