Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older

NCT03439657 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 2044872017-001220-22
• Study Type: interventional
• Target: 913
• Locations: 4 countries
• Sites: 13

Brief Summary

The purpose of this study is to assess immunogenicity and safety of GSK Biologicals' HZ vaccine when its first dose is co-administered with a pneumococcal polysaccharide conjugate vaccine (Prevenar13) in adults aged ≥50 YOA, as compared to the control group where the two HZ/su doses are administered subsequent to Prevenar13.

Conditions

Herpes Zoster

Keywords

HZ; Safety; Immunogenicity; Shingles; Adults; Prevenar 13

Outcome Measures

Primary Outcomes (5)

• Percentage of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in Co-Ad Group

  Vaccine response rate (VRR) for Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) humoral immunogenicity was determined by Enzyme Limked Immunosorbent Assay (ELISA). The VRR for anti-gE is defined as the percentage of subjects who had at least: a 4-fold increase in the anti-gE antibodies concentration as compared to the pre-vaccination anti-gE antibodies concentration, for subjects who are seropositive at baseline, or, a 4-fold increase in the anti-gE antibodies concentration as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who are seronegative at baseline.

  One month post-dose 2 (Month 3)

• Anti-gE Antibody Concentrations

  Anti-gE antibody concentrations in terms of Geometric Mean concentrations (GMC) were determined by ELISA and expressed as milli-international units per milliliter (mIU/mL)

  One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).

• Anti-pneumococcal Antibody Titers

  Anti-pneumococcal antibody titers for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) were determined by Multiplex Opsonophagocytosis Assay (MOPA)

  At one month post-dose 1 (Month 1)

• Adjusted Geometric Mean Concentrations (GMCs) for Anti-gE Antibody

  Anti-gE antibody concentrations (GMCs) adjusted for age and baseline concentrations were determined using Analysis Of Covariance (ANCOVA) model. Adjusted GMCs were expressed in milli-international units per milliliter (mIU/mL)

  One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).

• Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies

  Geometric mean antibody (anti-pneumococcal antibodies: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) titers adjusted for age and baseline concentration were determined using ANCOVA model.

  At one month post-dose 1 (Month 1)

Secondary Outcomes (10)

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

  Within 7 days (Day 1 - 7) after each vaccination

• Number of Days With Each Solicited Local Symptoms

  Within 7 days (Day 1 - 7) after each vaccination

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

  Within 7 days (Day 1 - 7) after each vaccination

• Number of Days With Solicited General Symptoms

  Within 7 days (Day 1 - 7) after each vaccination

• Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AE)

  Within 30 days (Day 1 to 30) after each vaccination

Study Arms (2)

Co-Ad Group

EXPERIMENTAL

Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm

Biological: HZ/su vaccine GSK1437173A; Biological: Prevenar13

Control Group

ACTIVE COMPARATOR

Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm

Biological: HZ/su vaccine GSK1437173A; Biological: Prevenar13

Interventions

HZ/su vaccine GSK1437173A BIOLOGICAL

2 doses of 0.5 mL of the vaccine in a 0,2 Months schedule. Administered by intramuscular injection into the deltoid muscle of the non-dominant arm.

Co-Ad Group; Control Group

Prevenar13 BIOLOGICAL

1 dose of 0.5 mL of the vaccine. Administered by intramuscular injection into the deltoid muscle of the dominant arm.

Also known as: PCV13

Co-Ad Group; Control Group

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.
• Written informed consent obtained from the subject prior to performance of any study specific procedure.
• A male or female, aged ≥50 YOA at the time of the first vaccination with the study vaccine(s).
• Female subjects of non-childbearing potential may be enrolled in the study.
• 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 vaccines during the period starting 30 days before the first dose of study vaccines (Day -30 to Day 1), or planned use during the study period.
• Any medical condition that in the judgment of the investigator would make intramuscular (IM) injection unsafe.
• Use or anticipated use of immunosuppressants or other immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of corticosteroids (\>14 consecutive days of prednisone at a dose of ≥20 mg/day \[or equivalent\]), long-acting immune modifying agents or immunosuppressive/cytotoxic therapy. Inhaled, topical and intra-articular corticosteroids are allowed.
• Administration or planned administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration. This includes any type of vaccine such as (but not limited to) live, inactivated and subunit vaccines.
• 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 vaccine/product.
• Previous and/or planned administration of an HZ or VZV vaccine other than the study vaccine during the study period.
• History of HZ.
• History of documented pneumococcal infection within 5 previous years.
• Prior receipt of any pneumococcal vaccine or planned use during the study period, other than the study vaccines.
• 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 vaccines.
• Acute disease and/or fever at the time of enrollment.
• Fever is defined as temperature ≥ 38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity.
• Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
• Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (13)

GSK Investigational Site

Marlborough, Massachusetts, 01752, United States

Location

GSK Investigational Site

Salisbury, North Carolina, 28144, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Truro, Nova Scotia, B2N 1L2, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1L 0H8, Canada

Location

GSK Investigational Site

Rakvere, 44316, Estonia

Location

GSK Investigational Site

Tallinn, 10117, Estonia

Location

GSK Investigational Site

Tartu, 50106, Estonia

Location

GSK Investigational Site

Weinheim, Baden-Wurttemberg, 69469, Germany

Location

GSK Investigational Site

Würzburg, Bavaria, 97070, Germany

Location

GSK Investigational Site

Essen, North Rhine-Westphalia, 45355, Germany

Location

GSK Investigational Site

Goch, North Rhine-Westphalia, 47574, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55116, Germany

Location

Related Publications (1)

• Min JY, Mwakingwe-Omari A, Riley M, Molo LY, Soni J, Girard G, Danier J. The adjuvanted recombinant zoster vaccine co-administered with the 13-valent pneumococcal conjugate vaccine in adults aged >/=50 years: A randomized trial. J Infect. 2022 Apr;84(4):490-498. doi: 10.1016/j.jinf.2021.12.033. Epub 2021 Dec 25.

  PMID: 34963639 DERIVED

MeSH Terms

Conditions

Herpes Zoster

Interventions

13-valent pneumococcal vaccine

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

GSKClinicalSupportHD@gsk.com

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: February 12, 2018
• First Posted: February 20, 2018
• Study Start: April 12, 2018
• Primary Completion: May 6, 2019
• Study Completion: March 3, 2020
• Last Updated: January 11, 2022
• Results First Posted: March 18, 2021

Record last verified: 2021-10

Locations

US (3); CA (2); ES (3); DE (5)