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

A Phase III, Randomized, Observer-blind, Placebo Controlled, Multicenter Clinical Trial to Assess Herpes Zoster Recurrence and the Reactogenicity, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine (HZ/su) When Administered Intramuscularly on a 0 and 2 Month Schedule to Adults ≥50 Years of Age With a Prior Episode of Herpes Zoster

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).

Study Overview

• Status: Completed
• Conditions: Herpes Zoster
• Intervention / Treatment: Biological: Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A); Drug: Placebo

Detailed Description

The study will be conducted in 2 epochs: Epoch 001- starting from visit day 1, followed by visit month 2 and then Visit 3 at one month post last vaccination (Month 3). Epoch 002- Starting with monthly contact after Visit 3 (Month 3) and ending at 26 months from the enrolment date.

• Study Type: Interventional
• Enrollment (Actual): 1430
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russia
  • Barnaul, Russia, 656043
    • GSK Investigational Site
  • Gatchina, Russia, 188300
    • GSK Investigational Site
  • Moscow, Russia, 115478
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions in the period up to 2 months after completion of the vaccination series.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HZ/su Group; 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); 2 doses of HZ/su vaccine were administered intramuscularly according to a 0,2 months vaccination schedule, at Day 1 and Month 2.
Placebo Comparator: Placebo Group; 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; 2 doses of Placebo were administered intramuscularly according to a 0,2 months vaccination schedule, at Day 1 and Month 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence Rate of Confirmed 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 PCR and the 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 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	Assessed solicited administration site events included erythema, pain, pruritus and swelling at the injection site. Any = occurrence of the event regardless of intensity grade. Grade 3 pain = significant pain at rest, which prevented normal, everyday activities. Grade 3 erythema, swelling = erythema, swelling with a surface diameter greater than (>) 100 millimeters (mm). Grade 3 pruritus = itchy sensation that prevented normal, everyday activities.	Within 7 days after each vaccination (occurring at Day 1 and Month 2)
Duration in Days of Solicited Administration Site Events	Duration is the number of days in which a participant experienced the symptom within the 7-day solicited follow-up period. Assessed solicited administration site events included erythema, pain, pruritus and swelling at the injection site.	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	Assessed solicited systemic events included fatigue, fever (defined as axillary temperature greater than or equal to (>=) 38.0°C/100.4°F), gastrointestinal symptoms, headache, malaise, myalgia, and shivering. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination. Grade 3 = event that prevented normal, everyday activities. Grade 3 fever = axillary temperature higher than (>) 39.0°C/102.2°F. Related = event assessed by the investigator as related to the study vaccination.	Within 7 days after each vaccination (occurring at Day 1 and Month 2)
Duration in Days of Solicited Systemic Events	Duration is the number of days in which a participant experienced the symptom within the 7-day solicited follow-up period. Assessed solicited systemic events included fatigue, fever (defined as axillary temperature >=38.0°C/100.4°F), gastrointestinal symptoms, headache, malaise, myalgia and shivering.	Within 7 days after each vaccination (occurring at Day 1 and Month 2)
Number of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Any = occurrence the event regardless of intensity grade or relation to the study vaccination. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as related to the study vaccination.	Within 30 days after each vaccination (occurring at Day 1 and Month 2)
Number of Participants With Any and Related Serious Adverse Events (SAEs)	An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination. Related = SAE assessed by the investigator as related to the study vaccination.	From first vaccination (Day 1) to 30 days post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)
Number of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs)	pIMDs are defined as 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. Any = occurrence of the pIMD regardless of intensity grade or relation to the study vaccination. Related = pIMD assessed by the investigator as related to the study vaccination.	From first vaccination (Day 1) to 30 days post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)
Number of Participants With Any and Related SAEs	An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination. Related = SAE assessed by the investigator as related to the study vaccination.	From 30 days post-last vaccination until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)
Number of Participants With Any and Related pIMDs	pIMDs are defined as 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. Any = occurrence of the pIMD regardless of intensity grade or relation to the study vaccination. Related = pIMD assessed by the investigator as related to the study vaccination.	From 30 days post-last vaccination until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)
Number of Participants With SAEs Related to Investigational Vaccine, Related to Study Participation or to GSK Concomitant Medication/Vaccine	An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. Any SAEs related to the investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator are reported.	From first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months)
Percentage of Participants With Vaccine Response for Anti-glycoprotein E (Anti-gE) Antibodies as Determined by Enzyme Linked Immunosorbent Assay (ELISA)	Vaccine response for anti-gE antibodies is defined as: For initially seronegative participants, anti-gE antibody concentration at post-vaccination >= 4-fold the cut-off value for anti-gE [97 international units per liter (IU/L)].; For initially seropositive participants, anti-gE antibody concentration at post-vaccination >= 4-fold the pre-vaccination anti-gE antibody concentration.	At Month 2 and Month 3
Anti-gE Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) as Determined by ELISA	Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in IU/L.	At Day 1, Month 2 and Month 3

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2019
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: September 3, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Shingles; Shingles recurrence; HZ; Vaccine response rate
• Additional Relevant MeSH Terms: Varicella Zoster Virus Infection; Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Herpes Zoster; Biological Products; Complex Mixtures; Vaccines
• Other Study ID Numbers: 204939; 2016-000744-34 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No