A Study on the Immune Response and Safety of a Vaccine Against Herpes Zoster in Adults Aged 50 Years and Older in India

NCT05219253 | Completed Phase 3 Results

• 1 other identifier: 214461
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study was to evaluate the humoral immunogenicity and safety of 2 doses of GSK Biologicals' Herpes Zoster subunit vaccine (HZ/su) administered for the prevention of Herpes Zoster (HZ) in adults aged 50 years of age (YOA) or older from India.

Conditions

Herpes Zoster

Keywords

Shingles; Herpes Zoster subunit vaccine; Immunogenicity; Safety; Adults aged 50 years and older; India

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Showing a Vaccine Response for Anti-glycoprotein E (gE)

  A participant with vaccine response for anti-gE was defined as a participant with: * at least a 4-fold greater post-last vaccination anti-gE antibody (Ab) concentration as compared to the pre-vaccination anti-gE Ab concentration, for participants who were seropositive at baseline, or * at least a 4-fold greater post-last vaccination anti-gE Ab concentration as compared to the anti-gE Ab cut-off value for seropositivity, for participants who were seronegative at baseline.

  At 1 month post-Dose 2 of study intervention administration (Month 3)

Secondary Outcomes (11)

• Anti-gE Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) and Between-group GMC Ratios

  At 1 month post-Dose 2 of study intervention administration (Month 3)

• Percentage of Participants Reporting Solicited Administration Site Events

  Within 7 days after each study intervention dose and across doses (vaccine/placebo administered at Day 1 and Month 2)

• Percentage of Participants Reporting Solicited Systemic Events

  Within 7 days after each study intervention dose and across doses (vaccine/placebo administered at Day 1 and Month 2)

• Percentage of Participants Reporting Unsolicited Adverse Events (AEs)

  Within 30 days after any study intervention dose administration (vaccine/placebo administered at Day 1 and Month 2)

• Percentage of Participants Reporting Serious Adverse Events (SAEs)

  From Dose 1 (Day 1) up to 30 days post-last study intervention dose

Study Arms (2)

HZ/su Group

EXPERIMENTAL

Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.

Biological: HZ/su

Placebo Group

PLACEBO COMPARATOR

Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.

Drug: Placebo

Interventions

HZ/su BIOLOGICAL

Two doses of the HZ/su vaccine administered intramuscularly, one each at Day 1 and Month 2.

HZ/su Group

Placebo DRUG

Two doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) administered intramuscularly, one each 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:

• Participants and/or participant's legally acceptable representative(s) (LAR) who in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written or witnessed/thumb printed informed consent obtained from the participant and/or participant's LAR(s) after the study has been explained according to local regulatory requirements and prior to performance of any study-specific procedure.
• A male or female aged 50 YOA or older at the time of the first study intervention.
• Healthy participants or medically stable patients as established by medical history and clinical examination before entering into the study.
• Female participants of non-childbearing potential may be enrolled in the study.
• Female participants of childbearing potential may be enrolled in the study, if the participant:
• has practiced adequate contraception for 1 month prior to study intervention administration, and
• has a negative pregnancy test on the day of study intervention administration, and
• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study intervention administration series.

You may not qualify if:

• Medical conditions
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s) vaccine or study materials or equipment.
• Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• History of HZ.
• Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
• Prior/Concomitant therapy
• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before first dose and ending 30 days after the last dose of study intervention administration with the exception of 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 intervention.
• \[In case an emergency mass vaccination for an unforeseen public health threat (e.g. a pandemic) is recommended and/or organised by the public health authorities, outside the routine immunisation programme, the time period described above can be reduced if necessary for that vaccine provided it is used according to local governmental recommendations and that the Sponsor is notified accordingly.\]
• Planned administration of long-acting immune-modifying drugs at any time during the study period.
• Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study intervention up to 1 month post-dose 2 (Month 3) or planned administration during the study period.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine. For corticosteroids, this will mean prednisone equivalent ≥ 20 mg/day or equivalent is not allowed. Inhaled, intra-articular and topical steroids are allowed.
• Previous vaccination against varicella or HZ.
• Prior/Concurrent clinical study experience Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/ invasive medical device).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (9)

GSK Investigational Site

Visakhapatnam, Andhra Pradesh, India

Location

GSK Investigational Site

North Guwāhāti, Assam, 781031, India

Location

GSK Investigational Site

Ahmedabad, Gujarat, 380005, India

Location

GSK Investigational Site

Mumbai, Maharashtra, India

Location

GSK Investigational Site

Chandigarh, Punjab, 160012, India

Location

GSK Investigational Site

Kanpur, 208002, India

Location

GSK Investigational Site

Mysore, 570004, India

Location

GSK Investigational Site

New Delhi, 110060, India

Location

GSK Investigational Site

Pune, 412216, India

Location

Related Publications (2)

• Naficy A, Chugh Y, Tariq M, Hawksworth H, Sankhe LR, Mwakingwe-Omari A. Immune response and safety of the adjuvanted recombinant zoster vaccine in adults 50 years of age and older in India: A randomized phase 3 trial. Vaccine. 2025 Mar 19;50:126819. doi: 10.1016/j.vaccine.2025.126819. Epub 2025 Feb 10.

  PMID: 39923547 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

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data was collected in an observer-blind manner.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 2, 2022
• Study Start: February 2, 2022
• Primary Completion: October 11, 2022
• Study Completion: December 12, 2022
• Last Updated: May 15, 2025
• Results First Posted: April 8, 2024

Record last verified: 2025-05

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

IN (9)