Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 65 Years of Age With and Without Zostavax® Vaccination at Least 5 Years Earlier

NCT02581410 | Completed Phase 3 Results

• 1 other identifier: 201198
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 32

Brief Summary

The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in adults ≥ 65 years of age with and without Zostavax® vaccination at least 5 years earlier.

Conditions

Herpes Zoster

Keywords

Zostavax®; ≥ 65 years of age; Herpes Zoster; Shingles; Immunogenicity; Safety

Outcome Measures

Primary Outcomes (8)

• Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations

  Varicella Zoster Virus (VZV) gE Ab.Immunoglobulin G (IgG) was determined by Enzyme Linked Immunosorbent Assay (ELISA). Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL). Geometric mean antibody concentrations were adjusted for group-matching variable.

  One month after dose 2, at Month 3

• Number of Subjects With Solicited Local Symptoms

  Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of the symptom regardless of its intensity grade. Grade 3 pain = Significant pain at rest that prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

  During the 7-day (Days 0-6) period after each dose.

• Number of Days With Solicited Local Symptoms

  Solicited local symptoms were assessed during the 7-day (Days 0-6) period after each dose.

  During the 7-day (Days 0-6) period after each dose.

• Number of Subjects With Solicited General Symptoms

  Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\] . Any = Occurrence of the symptom regardless of its intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

  During the 7-day (Days 0-6) period after each dose.

• Number of Days With Solicited General Symptoms

  Solicited general symptoms were assessed during the 7-day (Days 0-6) period after each dose.

  During the 7-day (Days 0-6) period after each dose.

• Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs)

  An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

  During the 30-day (Days 0-29) period after each dose.

• Number of Subjects With Any and Related Serious Adverse Events (SAEs)

  SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as related to the vaccination.

  From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)

• Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)

  pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

  From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)

Secondary Outcomes (4)

• Anti-gE Ab Concentrations

  At Months 0, 1, 3 and 14.

• Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells

  At Months 0, 1, 3 and 14.

• Number of Subjects With Any and Related SAEs

  From 30 days post last vaccination (Month 3) until study end at Month 14

• Number of Subjects With Any pIMDs

  From 30 days post last vaccination (Month 3) until study end at Month 14

Study Arms (2)

GSK1437173A Group

EXPERIMENTAL

Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.

Biological: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)

Control Group

ACTIVE COMPARATOR

Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.

Biological: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)

Interventions

GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A) BIOLOGICAL

2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.

Control Group; GSK1437173A Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: 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 ≥ 65 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject prior to performing any study specific procedure.
• For the No prev-Zvax group only:
• No previous vaccination with Zostavax.
• For the Prev-Zvax group only:
• Previous vaccination with Zostavax ≥ 5 calendar years earlier.
• Documentation indicating the date of previous Zostavax vaccination will be required.

You may not qualify if:

• Previous vaccination with Zostavax \< 5 calendar years earlier and/or anyone that ever received more than a single dose of Zostavax.
• Previous vaccination against VZV, administration of HZ/su vaccine or any other investigational or non-registered HZ vaccine (except Zostavax for the Prev-Zvax group).
• Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
• Chronic administration (defined as \> 14 consecutive days) of immunosuppressants or other immune-modifying drugs in the period starting 6 months prior to the first dose of vaccine. (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 (e.g., infliximab) in the period starting 6 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 in the period starting 8 days prior to and ending 14 days after either dose of study vaccine.
• Current participation in or planned concurrent participation 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.
• Planned administration of an HZ vaccine (including an investigational or non-registered vaccine) other than the study vaccine during the entire study.
• History of HZ or any suspected HZ between the screening visit and Visit 1.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/product.
• Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus \[HIV\] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
• Acute disease and/or fever at the time of enrolment.
• Fever is defined as temperature ≥ 37.5°C (99.5°F) by oral route, axillary or tympanic setting, or ≥ 38.0°C/100.4°F on rectal setting. The recommended route for recording temperature in this study will be oral.
• Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
• Administration of immunoglobulins and/or any blood products in the period starting 3 months preceding the first dose of study vaccine or planned administration during the study period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (32)

GSK Investigational Site

Huntsville, Alabama, 35802, United States

Location

GSK Investigational Site

Daly City, California, 94015, United States

Location

GSK Investigational Site

Los Gatos, California, 95032, United States

Location

GSK Investigational Site

Oakland, California, 94612, United States

Location

GSK Investigational Site

Roseville, California, 95661, United States

Location

GSK Investigational Site

Santa Rosa, California, 95405, United States

Location

GSK Investigational Site

Boise, Idaho, 83642, United States

Location

GSK Investigational Site

Lenexa, Kansas, 66219, United States

Location

GSK Investigational Site

Newton, Kansas, 67114, United States

Location

GSK Investigational Site

Wichita, Kansas, 67207, United States

Location

GSK Investigational Site

Auburn, Maine, 04210, United States

Location

GSK Investigational Site

Columbia, Maryland, 21045, United States

Location

GSK Investigational Site

Elkridge, Maryland, 21075, United States

Location

GSK Investigational Site

Marlborough, Massachusetts, 01752, United States

Location

GSK Investigational Site

Binghamton, New York, 13901, United States

Location

GSK Investigational Site

Endwell, New York, 13760, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28209, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44122, United States

Location

GSK Investigational Site

Corvallis, Oregon, 97330, United States

Location

GSK Investigational Site

Erie, Pennsylvania, 16506, United States

Location

GSK Investigational Site

Erie, Pennsylvania, 16508, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

GSK Investigational Site

Uniontown, Pennsylvania, 15401, United States

Location

GSK Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Layton, Utah, 84041, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84109, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84121, United States

Location

GSK Investigational Site

South Jordan, Utah, 84095, United States

Location

GSK Investigational Site

Newport News, Virginia, 23606, United States

Location

GSK Investigational Site

Eau Claire, Wisconsin, 54701, United States

Location

GSK Investigational Site

Marshfield, Wisconsin, 54449, United States

Location

Related Publications (2)

• Dagnew AF, Klein NP, Herve C, Kalema G, Di Paolo E, Peterson J, Salaun B, Schuind A. The Adjuvanted Recombinant Zoster Vaccine in Adults Aged >/=65 Years Previously Vaccinated With a Live-Attenuated Herpes Zoster Vaccine. J Infect Dis. 2021 Oct 13;224(7):1139-1146. doi: 10.1093/infdis/jiaa083.

  PMID: 32103273 DERIVED

• Grupping K, Campora L, Douha M, Heineman TC, Klein NP, Lal H, Peterson J, Vastiau I, Oostvogels L. Immunogenicity and Safety of the HZ/su Adjuvanted Herpes Zoster Subunit Vaccine in Adults Previously Vaccinated With a Live Attenuated Herpes Zoster Vaccine. J Infect Dis. 2017 Dec 12;216(11):1343-1351. doi: 10.1093/infdis/jix482.

  PMID: 29029122 DERIVED

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

Interventions

Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 21, 2015
• Study Start: December 15, 2015
• Primary Completion: August 30, 2016
• Study Completion: August 1, 2017
• Last Updated: August 28, 2018
• Results First Posted: September 26, 2017

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

US (32)