Month 30 & 42 Extension Studies of CRD-004 Primary Study - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00492648

Purpose

The safety and immunogenicity of the GSK324332A vaccine has been evaluated up to Month 12 post-vaccination in the primary study. In the extension studies presented here, the persistence of the cellular and humoral immune responses will be evaluated 30 and 42 months after the first vaccination in young and elderly adults who received the GSK324332A vaccine. This protocol posting deals only with objectives & outcome measures of the extension phase at Months 30 and 42. No new recruitment will be done in these extension phases of the primary study. No vaccines are administered in this phase of the study.

Condition	Intervention	Phase
Herpes Zoster (Shingles)	Procedure: Blood sampling for assay of persistence of immunogenicity	Phase II

MedlinePlus related topics: Shingles

Drug Information available for: Zostavax

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Extension Study to Evaluate the Persistence of the Immune Responses Induced by GSK Biologicals Zoster Vaccine, GSK324332A, Administered in Healthy Adult Subjects Aged 18-30 Years and 50-70 Years

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Frequencies of gE-specific CD4 T cells with at least two antigen-specific cytokines (IFN-У, IL-2, TNF-α, CD40L). [ Time Frame: At months 30 and 42 after the first vaccination. ] [ Designated as safety issue: No ]
Frequencies of VZV-specific CD4 T cells with at least two antigen-specific cytokines (IFN-У, IL-2, TNF-α, CD40L). [ Time Frame: At months 30 and 42 after the first vaccination. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Frequencies of gE-specific CD4/CD8 T cells with antigen-specific IFN-У and/or IL-2 and/or TNF α and/or CD40L secretion/expression. [ Time Frame: At months 30 and 42 ] [ Designated as safety issue: No ]
Frequencies of VZV-specific CD4/CD8 T cells with antigen-specific IFN-У and/or IL-2 and/or TNF α and/or CD40L secretion/expression. [ Time Frame: At months 30 and 42. ] [ Designated as safety issue: No ]
Anti-gE -Ab concentrations [ Time Frame: At months 30 and 42. ] [ Designated as safety issue: No ]
Anti-VZV Ab concentrations [ Time Frame: At months 30 and 42 ] [ Designated as safety issue: No ]
Frequencies of gE-specific memory B cells [ Time Frame: At months 30 and 42. ] [ Designated as safety issue: No ]
Frequencies of VZV-specific memory B cells [ Time Frame: At months 30 and 42 ] [ Designated as safety issue: No ]
Occurrence of SAEs [ Time Frame: During the whole study period. ] [ Designated as safety issue: Yes ]
Occurrence of clinically diagnosed HZ episodes [ Time Frame: From last visit (Month 12) in the primary study till end of the extension studies. ] [ Designated as safety issue: Yes ]

Enrollment:	34
Study Start Date:	June 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental Subjects aged 18 to 30 years old	Procedure: Blood sampling for assay of persistence of immunogenicity Two blood samples: 30 and 42 months after first vaccination
Group B: Experimental Subjects aged 50 to 70 years old.	Procedure: Blood sampling for assay of persistence of immunogenicity Two blood samples: 30 and 42 months after first vaccination

Detailed Description:

All subjects in these extension phases of the study were previously vaccinated with the investigational herpes zoster vaccine GSK1437173A. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
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 should be enrolled in the study;
Subjects who successfully completed the primary study and who did not receive Varilrix in the primary study;
Written informed consent obtained from the subject;
Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) within 1 month preceding the study start, or planned use during the study period;
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first study procedure, including corticosteroids, except inhaled and topical steroids are allowed;
Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks before the first study procedure, with the exception of the Influenza vaccine, which can be administered 1 week preceding the first study procedure;
Previous vaccination against HZ, except the study vaccine administered in the primary study;
History of HZ (shingles);
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination;
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first study procedure or planned administration during the study period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492648

Locations

Belgium
GSK Investigational Site
Gent, Belgium, 9000

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	109671, 109674
Study First Received:	June 26, 2007
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00492648
Health Authority:	Belgium: Institutional Review Board

Keywords provided by GlaxoSmithKline:

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

GSK Biologicals
Cell mediated immunity (CMI)
Intracellular cytokine staining (ICS)

Study placed in the following topic categories:

Virus Diseases
Herpes Zoster
Chickenpox
DNA Virus Infections

Chicken pox
Healthy
Varicella Zoster
Herpesviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009