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Herpes ZosterPhase 3NCT05219253

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

A Phase 3 study testing HZ/su in people with Herpes Zoster, run by GlaxoSmithKline at 9 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Herpes Zoster
What is being tested?
HZ/su
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
288 participants
Where
9 sitesIndia
Study dates
2 Feb 2022to 12 Dec 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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).
  • Other exclusions
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months of last study intervention administration.
  • Indications of drug abuse or excess alcohol use as deemed by investigator to potentially confound safety assessments or render participant unable or unlikely to adhere to protocol requirements.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

India9 sites

  • GSK Investigational Site

    Ahmedabad, Gujarat, 380005

  • GSK Investigational Site

    Chandigarh, Punjab, 160012

  • GSK Investigational Site

    Kanpur, 208002

  • GSK Investigational Site

    Mumbai, Maharashtra

  • GSK Investigational Site

    Mysore, 570004

  • GSK Investigational Site

    New Delhi, 110060

  • GSK Investigational Site

    North Guwāhāti, Assam, 781031

  • GSK Investigational Site

    Pune, 412216

  • GSK Investigational Site

    Visakhapatnam, Andhra Pradesh

Other trials in India

About this study

Official title: A Phase 3, Randomised, Observer-blind, Placebo-controlled, Multi-centre Study to Evaluate the Immune Response and Safety of the Herpes Zoster Subunit Vaccine When Administered Intramuscularly on a 2-dose Schedule in Adults Aged 50 Years and Older in India

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
Being tested
HZ/su, Placebo
Keywords
Shingles, Herpes Zoster subunit vaccine, Immunogenicity, Safety, Adults aged 50 years and older, India
Medical subject headings
Herpes Zoster

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HZ/suBiological

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

  • PlaceboDrug

    Two doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) administered intramuscularly, one each at Day 1 and Month 2.

Study groups in NCT05219253
Study groupRoleWhat they receive
HZ/su GroupExperimentalParticipants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.
Receives: Biological: HZ/su
Placebo GroupPlacebo comparatorParticipants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (11)

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

    Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as GMCs in milli-international units per milliliter (mIU/mL).

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

  2. Percentage of Participants Reporting Solicited Administration Site Events

    The assessed solicited administration site events included injection site erythema, pain, pruritus and swelling.

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

  3. Percentage of Participants Reporting Solicited Systemic Events

    The assessed solicited systemic events included fatigue, fever, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia and shivering.

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

  4. Percentage of Participants Reporting Unsolicited Adverse Events (AEs)

    An unsolicited AE was defined as an AE that was not included in a list of solicited events using a participant diary. Unsolicited events must have been spontaneously communicated by a participant who had signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.

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

  5. Percentage of Participants Reporting Serious Adverse Events (SAEs)

    An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or an abnormal pregnancy outcome, or an important medical event that may not have been life-threatening or resulted in death or hospitalization, but may have jeopardized the participant or required medical or surgical intervention to prevent one of the aforementioned outcomes.

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

  6. Percentage of Participants Reporting Potential Immune-mediated Diseases (pIMDs)

    pIMDs were defined as a subset of AEs of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology.

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

  7. Percentage of Participants Reporting SAEs

    An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or an abnormal pregnancy outcome, or an important medical event that may not have been life-threatening or resulted in death or hospitalization, but may have jeopardized the participant or required medical or surgical intervention to prevent one of the aforementioned outcomes.

    Measured: From Dose 1 (Day 1) up to study end (Month 8)

  8. Percentage of Participants Reporting pIMDs

    pIMDs were defined as a subset of AEs of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology.

    Measured: From Dose 1 (Day 1) up to study end (Month 8)

  9. Anti-gE Antibody Concentrations Expressed as GMCs

    Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL.

    Measured: At pre-study intervention administration (Day 1) and at 1 month post-Dose 2 of study intervention administration (Month 3)

  10. Percentage of Participants Seropositive for Anti-gE Antibodies

    A participant seropositive for anti-gE antibodies was defined as a participant whose antibody concentration was greater than or equal to (>=) the assay cut-off value (97 mIU/mL).

    Measured: At pre-study intervention administration (Day 1) and at 1 month post-Dose 2 of study intervention administration (Month 3)

  11. Mean Geometric Increase (MGI) of Anti-gE Antibody Concentrations

    MGI was defined as the geometric mean of the within participant ratios of anti-gE antibody concentration at 1 month post-Dose 2 (Month 3) compared to pre-study intervention administration (Day 1) anti-gE antibody concentration.

    Measured: At 1 month post-Dose 2 of study intervention administration (Month 3) compared to pre-study intervention administration (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2022
  2. Study start2 Feb 2022
  3. Primary completion11 Oct 2022
  4. Study completion12 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05219253
Sponsor's protocol ID
214461
Status last verified
May 2025
First submitted
21 Jan 2022
Last updated
15 May 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 39923547

  • 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.

    PubMed 37781954

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HZ/su in people with Herpes Zoster, run by GlaxoSmithKline at 9 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Showing a Vaccine Response for Anti-glycoprotein E (gE) (time frame: At 1 month post-Dose 2 of study intervention administration (Month 3)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05219253, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.

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