Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A When Administered Subcutaneously Intramuscularly in Adults Aged ≥50 Years

NCT01777321 | Completed Phase 3 Results

• 2 other identifiers: 1167602012-005671-14
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of GSK Biologicals' Herpes Zoster (HZ) vaccine (GSK 1437173A) when administered subcutaneously (SC) as compared to intramuscularly (IM) to people 50 years of age and older.

Conditions

Herpes Zoster

Keywords

Herpes Zoster; Intramuscular; Subcutaneous; Safety; ≥50 years of age; Adults; Immunogenicity; Elderly

Outcome Measures

Primary Outcomes (11)

• Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL)

  A seropositive subject was defined as a subject whose anti-gE Ab concentration was greater than or equal to the assay cut-off value, of 18 mIU/mL.

  Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)

• Anti-gE Antibody Concentrations

  Anti-gE antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in mIU/mL.

  Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)

• Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations

  Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x18 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.

  At two months after Dose 1 (M2) and one month after Dose 2 (M3)

• Descriptive Statistics of Anti-gE Antibody Concentrations

  Anti-gE antibody concentrations were assessed by the Enzyme Lynked Immunosorbent Assay.

  Before vaccination (PRE), at two months after dose 1 (M2) and one month after Dose 2 (M3)

• Number of Subjects With Solicited Local Symptoms

  The solicited local symptoms assessed were: Arm movement/range of motion of the vaccinated arm, Injection site pruritus, Pain, Redness, and Swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest that prevented normal every day activities. Grade 3 Injection site pruritus = Significant pruritus that prevented normal every day activities. Grade 3 impairment of arm movement/range of motion = Significant impairment of arm movement/range of motion that prevented normal every day activities.

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

• Number of Subjects With Solicited General Symptoms

  Assessed solicited general symptoms were: Fatigue, Fever, Gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), Headache, Myalgia, and Shivering. Fever = axillary temperature ≥37.5°C. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Fever = axillary temperature higher than (\>) 39.0°C. Related = general symptom assessed by the investigator as causally related to vaccination.

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

• Mean Number of Days With Local Symptoms

  Days with solicited local symptoms were tabulated for the total vaccinated cohort.

  During the 7 day (Days 0-6) post vaccination, after each dose (D)

• Mean Number of Days With General Symptoms

  Days with solicited general symptoms were tabulated for the total vaccinated cohort.

  During the 7 day (Days 0-6) post vaccination, after each dose (D)

• Number of Subjects With Potential Immune-Mediated Disorders (pIMDs)

  Potential immune-mediated diseases (pIMDs) were 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 Month 0 to Month 3

• Number of Subjects With Unsolicited Adverse Events (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.

  Within 30 days (Days 0-29) post vaccination period

• Number of Subjects With Serious Adverse Events (SAEs)

  Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  From Month 0 to Month 3

Secondary Outcomes (5)

• Number of Subjects With Anti-gE Antibody Concentrations ≥ 97 mIU/mL

  At Month 14

• Anti-gE Antibody Concentrations

  At Month 14

• Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations

  Twelve Months after Dose 2 (M14)

• Number of Subjects With pIMDs

  Up to Month 14 post vaccination period

• Number of Subjects With SAEs

  Up to Month 14 post vaccination period

Study Arms (2)

SC HZ/su Group

EXPERIMENTAL

Subjects will receive HZ/su vaccine administered SC on a 0,2-month schedule.

Biological: Herpes zoster vaccine GSK1437173A

IM HZ/su Group

ACTIVE COMPARATOR

Subjects will receive HZ/su vaccine administered IM on a 0,2-month schedule.

Biological: Herpes zoster vaccine GSK1437173A

Interventions

Herpes zoster vaccine GSK1437173A BIOLOGICAL

HZ/su vaccine administered either into the subcutaneous tissue of the upper arm (deltoid region) of the non-dominant arm or intramuscularly in the deltoid region of non-dominant arm on a 0,2-month schedule.

IM HZ/su Group; SC HZ/su Group

Eligibility Criteria

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

You may qualify if:

• Subject who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Subject, residing in Japan, is of Japanese ethnic origin, defined as having been born in Japan with four ethnic Japanese grandparents and able to speak Japanese.
• Subject has provided written informed consent.
• Subject, male or female, who is 50 YOA or older at the time of the first vaccination.
• Subject, if female, of non-childbearing potential may be enrolled in the study.
• Subject, if female, 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 (i.e., for 2 months after Month 2).

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Concurrently participating or planned 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.
• Administration or planned administration of a live vaccine within 30 days prior to the first study vaccination through 30 days after the second study vaccination.
• Administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine.
• Planned administration, during the study, of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
• Administration of immunoglobulins and/or any blood products within the three (3) months preceding the first dose of study vaccine or planned administration during the study period.
• Chronic administration (defined as \>14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• For corticosteroids, a prednisone dose of \<20 mg/day, or equivalent, is allowed.
• Inhaled, topical, and intra-articular corticosteroids are allowed.
• Administration or planned administration of long-acting immune-modifying drugs (e.g., infliximab) within six months prior to the first vaccine dose through the duration of the study period.
• History of HZ.
• Previous vaccination against HZ or varicella (registered or investigational product).
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study material and equipment.
• Significant underlying illness that, in the opinion of the investigator, would be expected to prevent completion of the study.
• Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Fukuoka, 812-0025, Japan

Location

Related Publications (2)

• de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.

  PMID: 37781954 DERIVED

• Vink P, Shiramoto M, Ogawa M, Eda M, Douha M, Heineman T, Lal H. Safety and immunogenicity of a Herpes Zoster subunit vaccine in Japanese population aged >/=50 years when administered subcutaneously vs. intramuscularly. Hum Vaccin Immunother. 2017 Mar 4;13(3):574-578. doi: 10.1080/21645515.2016.1232787. Epub 2016 Dec 9.

  PMID: 27936344 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

Condition Hierarchy (Ancestors)

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

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

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 28, 2013
• Study Start: June 17, 2013
• Primary Completion: October 10, 2013
• Study Completion: November 11, 2014
• Last Updated: October 25, 2018
• Results First Posted: January 6, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)