Consistency, Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults ≥ 50 Years of Age

NCT02075515 | Completed Phase 3 Results

• 2 other identifiers: 1171772013-000373-76
• Study Type: interventional
• Target: 651
• Locations: 3 countries
• Sites: 8

Brief Summary

The purpose of this study is to demonstrate lot-to-lot consistency in terms of immunogenicity, and evaluate safety of the Herpes Zoster subunit (HZ/su) vaccine. The study is designed as a randomized, double-blind study with three parallel groups.

Conditions

Herpes Zoster; Herpes Zoster Vaccine

Keywords

Safety; Zoster; Immunogenicity; Adults; Consistency

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value

  Anti-gE antibody concentrations, as determined by Enzyme-linked Immunosorbent Assay (ELISA). The cut-off value was ≥ 97 milli international units per milliliter (mIU/mL).

  At Month 3

Secondary Outcomes (9)

• Anti-gE Humoral Immunogenicity

  At Month 0 and Month 3

• Number of Vaccine Responders for Anti-gE Concentrations as Determined by ELISA

  At Month 3

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

  Within 7 days (Days 0-6) after each vaccine dose and across doses

• Number of Days With Any Solicited Local Symptoms

  During the 7 days (Days 0-6) after each vaccine dose

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

  Within 7 days (Days 0-6) after each vaccine dose and across doses

Study Arms (3)

HZ/su Lot A

EXPERIMENTAL

Subjects will receive Lot A of the HZ/su vaccine at 0 and 2 months. The HZ/su vaccine composed of unique randomized combinations of an adjuvant lot and one gE lot.

Biological: Herpes Zoster vaccine (GSK 1437173A)

HZ/su Lot B

EXPERIMENTAL

Subjects will receive Lot B of the HZ/su vaccine at 0 and 2 months. The HZ/su vaccine composed of unique randomized combinations of an adjuvant lot and one gE lot.

Biological: Herpes Zoster vaccine (GSK 1437173A)

HZ/su Lot C

EXPERIMENTAL

Subjects will receive Lot C of the HZ/su vaccine at 0 and 2 months. The HZ/su vaccine composed of unique randomized combinations of an adjuvant lot and one gE lot.

Biological: Herpes Zoster vaccine (GSK 1437173A)

Interventions

Herpes Zoster vaccine (GSK 1437173A) BIOLOGICAL

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

Also known as: HZ/su vaccine

HZ/su Lot A; HZ/su Lot B; HZ/su Lot C

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. A prednisone dose of \< 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
• 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 (E.g. inactivated and subunit vaccines) within 8 days prior to or within 14 days after either dose of study vaccine.
• 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.
• 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 product.
• Previous vaccination against HZ or varicella.
• Planned administration during the study of an HZ or varicella vaccine other than the study vaccine.
• History of HZ.
• 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.
• Acute disease and/or fever at the time of enrollment.
• Fever is defined as temperature ≥ 37.5°C (99.5°F) on 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 without fever may be enrolled at the discretion of the investigator.
• Administration of immunoglobulins and/or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
• Pregnant or lactating females.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Mesa, Arizona, 85213, United States

Location

GSK Investigational Site

Wichita, Kansas, 67207, United States

Location

GSK Investigational Site

Milford, Massachusetts, 01757, United States

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Wilrijk, 2610, Belgium

Location

GSK Investigational Site

Coquitlam, British Columbia, V3K 3P4, Canada

Location

GSK Investigational Site

Brampton, Ontario, L6T 0G1, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Related Publications (1)

• Strezova A, Godeaux O, Aggarwal N, Leroux-Roels G, Lopez-Fauqued M, Van Damme P, Vanden Abeele C, Vastiau I, Heineman TC, Lal H. A randomized lot-to-lot immunogenicity consistency study of the candidate zoster vaccine HZ/su. Vaccine. 2017 Dec 4;35(48 Pt B):6700-6706. doi: 10.1016/j.vaccine.2017.10.017. Epub 2017 Oct 24.

  PMID: 29079101 BACKGROUND

Related Links

• IPD for this study will be made available via the Clinical Study Data Request site.

MeSH Terms

Conditions

Herpes Zoster

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

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 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 3, 2014
• Study Start: August 13, 2014
• Primary Completion: April 29, 2015
• Study Completion: April 25, 2016
• Last Updated: May 14, 2021
• Results First Posted: May 24, 2017

Record last verified: 2021-04

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

CA (3); US (3); BE (2)