Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations in Adults >= 50 Years

NCT00802464 | Completed Phase 2 Results

• 2 other identifiers: 1120772008-005120-86
• Study Type: interventional
• Target: 410
• Locations: 3 countries
• Sites: 12

Brief Summary

The goal of this randomized observer-blind trial is to further refine the formulation of vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune responses and the safety profiles of the different formulations.

Conditions

Herpes Zoster

Keywords

Cytokine; Vaccine; Herpes Zoster (HZ); Cell mediated immunity (CMI); Antibody response; Varicella Zoster Virus (VZV); Shingles

Outcome Measures

Primary Outcomes (4)

• Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers

  The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).

  One month after the second vaccination (Month 3)

• Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers

  The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).

  One month after the second vaccination (Month 3)

• Anti-glycoprotein E (gE) Antibody Concentrations

  Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

  One month after the second vaccination (Month 3)

• Anti-VZV Antibody Concentrations

  Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

  One month after the second vaccination (Month 3)

Secondary Outcomes (16)

• Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers

  At Month 0 and at Month 2

• Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers

  At Month 0 and at Month 2

• Anti-gE Antibody Concentrations

  At Month 0 and at Month 2

• Anti-VZV Antibody Concentrations

  At Month 0 and at Month 2

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms

  During the 7-day (Days 0-6) post-vaccination period after each dose and across doses

Study Arms (4)

GSK1437173A formulation 1 Group

EXPERIMENTAL

Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.

Biological: Herpes zoster vaccine GSK1437173A

GSK1437173A formulation 2 Group

EXPERIMENTAL

Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) GSK1437173A formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.

Biological: Herpes zoster vaccine GSK1437173A

GSK1437173A formulation 3 Group

EXPERIMENTAL

Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.

Biological: Herpes zoster vaccine GSK1437173A

Control Group

PLACEBO COMPARATOR

Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.

Biological: Placebo

Interventions

Herpes zoster vaccine GSK1437173A BIOLOGICAL

2 vaccinations at Months 0 and 2 with GSK1437173A (different formulations)

Also known as: gE/AS01E, gE/AS01B

GSK1437173A formulation 1 Group; GSK1437173A formulation 2 Group; GSK1437173A formulation 3 Group

Placebo BIOLOGICAL

2 vaccinations at Months 0 and 2 with placebo

Also known as: Placebo/Saline

Control Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A male or female 50 years of age or above at the time of the first vaccination;
• Written informed consent obtained from the subject;
• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study;
• If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;
• Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before the first study vaccination or scheduled within 30 days after study vaccination;
• Previous vaccination against HZ;
• Previous vaccination against varicella;
• History of HZ;
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
• Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy;
• 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;
• Acute disease at the time of enrolment.
• Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study;
• History of or current drug and/or alcohol abuse;
• Pregnant or lactating female;
• Female planning to become pregnant or planning to discontinue contraceptive precautions if of childbearing potential.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (12)

GSK Investigational Site

Phoenix, Arizona, 85020, United States

Location

GSK Investigational Site

Pembroke Pines, Florida, 33024, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89130, United States

Location

GSK Investigational Site

Edison, New Jersey, 08817, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27612, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44122, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15236, United States

Location

GSK Investigational Site

Hradec Králové, 500 01, Czechia

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Barcelona, Spain

Location

GSK Investigational Site

Mahadahonda( Madrid, 28222, Spain

Location

GSK Investigational Site

Marid, 28040, Spain

Location

Related Publications (1)

• Chlibek R, Bayas JM, Collins H, de la Pinta ML, Ledent E, Mols JF, Heineman TC. Safety and immunogenicity of an AS01-adjuvanted varicella-zoster virus subunit candidate vaccine against herpes zoster in adults >=50 years of age. J Infect Dis. 2013 Dec 15;208(12):1953-61. doi: 10.1093/infdis/jit365. Epub 2013 Jul 31.

  PMID: 23904292 BACKGROUND

Related 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.

MeSH Terms

Conditions

Herpes Zoster; Chickenpox

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: January 12, 2009
• Primary Completion: July 2, 2010
• Study Completion: July 2, 2010
• Last Updated: June 26, 2019
• Results First Posted: December 12, 2017

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

US (7); CZ (1); ES (4)