Safety and Immunogenicity Study of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) With a Prior Episode of Herpes Zoster

NCT04091451 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 2049392016-000744-34
• Study Type: interventional
• Target: 1,430
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study was to assess the safety and immunogenicity of GSK Biologicals' HZ/su vaccine when given on a two-dose schedule to adults aged 50 years and above who had a previous episode of Herpes Zoster (HZ).

Conditions

Herpes Zoster

Keywords

Shingles; Shingles recurrence; HZ; Vaccine response rate

Outcome Measures

Primary Outcomes (1)

• Incidence Rate of Confirmed Herpes Zoster (HZ) Cases

  A suspected case of HZ is defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ was confirmed by an algorithm that included Polymerase Chain Reaction (PCR) and the HZ Ascertainment Committee (HZAC) determination. The incidence rate (n/T) of confirmed HZ cases, expressed in terms of 1000 person-years rate, was calculated as the number of participants reporting at least one confirmed HZ case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 1000.

  From 30 days post-second vaccination (Month 3) until study end (duration of approximately 2 years to 4 years and 5 months)

Secondary Outcomes (13)

• Incidence Rate of Confirmed HZ Cases

  From first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months)

• Number of Participants With Any and Grade 3 Solicited Administration Site Events

  Within 7 days after each vaccination (occurring at Day 1 and Month 2)

• Duration in Days of Solicited Administration Site Events

  Within 7 days after each vaccination (occurring at Day 1 and Month 2)

• Number of Participants With Any, Grade 3 and Related Solicited Systemic Events

  Within 7 days after each vaccination (occurring at Day 1 and Month 2)

• Duration in Days of Solicited Systemic Events

  Within 7 days after each vaccination (occurring at Day 1 and Month 2)

Study Arms (2)

HZ/su Group

EXPERIMENTAL

Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.

Biological: Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A)

Placebo Group

PLACEBO COMPARATOR

Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.

Drug: Placebo

Interventions

Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A) BIOLOGICAL

2 doses of HZ/su vaccine were administered intramuscularly according to a 0,2 months vaccination schedule, at Day 1 and Month 2.

HZ/su Group

Placebo DRUG

2 doses of Placebo were administered intramuscularly according to a 0,2 months vaccination schedule, at Day 1 and Month 2.

Placebo Group

Eligibility Criteria

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

You may qualify if:

• Subjects and/or subject's LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol
• Written informed consent obtained from the subject/subject's LAR(s) prior to performance of any study specific procedure.
• A male or female ≥ 50 YOA at the time of the first vaccination.
• Subjects with a history of HZ. Confirmation of the prior HZ diagnosis can be done by one of the following three methods:
• Clinically diagnosed HZ:
• OR Laboratory diagnosed HZ: OR
• HZ diagnosed by an adjudication committee: Female subjects of non-childbearing potential may be enrolled in the study.
• Non-childbearing potential is defined as current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, bilateral salpingectomy 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 for 2 months after completion of the vaccination series.

You may not qualify if:

• Subjects who at time of study entry or during the maximum period of anticipated study participation are/will become part of the population recommended to receive a zoster vaccine per existing local or national immunization practices will be excluded from study participation.
• 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.
• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
• Onset of HZ in the past 6 months or any ongoing symptoms from a prior HZ episode.
• Chronic antiviral use for HZ prophylaxis.
• History of \>1 prior episode of HZ.
• A history of disseminated HZ, cutaneous or associated with visceral disease or associated with neurologic disease caused by VZV infection.
• Use or anticipated use of immunosuppressants or 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, long-acting immune-modifying agents or immunosuppressive/cytotoxic therapy
• Administration or planned administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine. However, licensed pneumococcal vaccines and non-replicating vaccines may be administered up until 8 days prior to dose 1 and/or dose 2 and/or at least 14 days after any dose of study vaccine.
• 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 vaccination against VZV or HZ.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
• 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 enrolment.
• 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 (3)

GSK Investigational Site

Barnaul, 656043, Russia

Location

GSK Investigational Site

Gatchina, 188300, Russia

Location

GSK Investigational Site

Moscow, 115478, Russia

Location

Related Publications (2)

• Jegede B, Zhou Y, Hawksworth H, Hui DSC, Montenegro Guerra N, Poder A, Ramon JM, Valimaa H, Villanueva-Quintero GD, Mwakingwe-Omari A; Z-062 study group. Herpes zoster recurrence, and safety and immunogenicity of the recombinant zoster vaccine in adults aged >/=50 years with a history of herpes zoster: A phase 3, randomized controlled trial. J Infect. 2025 Sep;91(3):106573. doi: 10.1016/j.jinf.2025.106573. Epub 2025 Aug 6.

  PMID: 40780591 BACKGROUND

• 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

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

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 16, 2019
• Study Start: September 17, 2019
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: December 4, 2025
• Results First Posted: March 30, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.

Locations

RU (3)