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Herpes ZosterPhase 3NCT05371080

A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults

A Phase 3 study testing HZ/su vaccine in people with Herpes Zoster, run by GlaxoSmithKline at 107 sites in 18 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of the current ZOSTER-101 long-term follow-up (LTFU) study of ZOSTER-049 (NCT02723773) study, an extension of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies, is to assess the long-term vaccine efficacy (VE) against Herpes Zoster (HZ) (approximately 11-15 years post primary… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Herpes Zoster
What is being tested?
HZ/su vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,038 participants
Where
107 sitesin 18 countries
Study dates
10 Aug 2022to 23 Aug 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants and participant's caregiver, who, in the opinion of the investigator, can and are willing to comply with the requirements of the protocol.
  • Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study-specific procedure.
  • Medically stable participants as established by medical history and clinical examination before entering into the study.
  • Participants who completed ZOSTER-049 study (following at least 1 dose of HZ/su in ZOSTER-006/022 studies).

Who cannot join

  • Medical conditions
  • Any clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
  • Prior/Concomitant therapy
  • Use of any investigational or non-registered product (drug, vaccine or medical device) for the treatment of HZ or Varicella Zoster Virus (VZV) infection at the time of enrolment or their planned use during the study period.
  • Previous vaccination against VZV or HZ and/or planned administration during the study of a VZV or HZ vaccine (including an investigational or non-registered vaccine other than HZ/su administered in studies ZOSTER-006/022 or ZOSTER-049).
  • 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) for the prevention and/or treatment of HZ or VZV and which may have a possible activity against VZV.

Trial locations and contacts

107 sites in 18 countries.

107 sites in 18 countries

Germany17 sites

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 51069

  • GSK Investigational Site

    Dresden, Saxony, 01097

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45355

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45359

  • GSK Investigational Site

    Flörsheim, Hesse, 65439

  • GSK Investigational Site

    Freiberg, Saxony, 09599

  • GSK Investigational Site

    Goch, North Rhine-Westphalia, 47574

  • GSK Investigational Site

    Hamburg, 22143

  • GSK Investigational Site

    Hamburg, 22415

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39112

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55116

  • GSK Investigational Site

    Rednitzhembach, Bavaria, 91126

  • GSK Investigational Site

    Wallerfing, Bavaria, 94574

  • GSK Investigational Site

    Wangen, Baden-Wurttemberg, 88239

  • GSK Investigational Site

    Weinheim, Baden-Wurttemberg, 69469

  • GSK Investigational Site

    Witten, North Rhine-Westphalia, 58455

Other trials in Germany

Spain11 sites

  • GSK Investigational Site

    Balenyà (Barcelona), 08550

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona, 8025

  • GSK Investigational Site

    Centelles (Barcelona), 08540

  • GSK Investigational Site

    La Roca del Vallès, 08430

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Majadahonda( Madrid, 28222

  • GSK Investigational Site

    Marid, 28040

  • GSK Investigational Site

    Peralada( Girona), 17491

  • GSK Investigational Site

    Valencia, 46020

  • GSK Investigational Site

    Vic, 28500

Other trials in Spain

Canada10 sites

  • GSK Investigational Site

    Halifax, Nova Scotia, B3K 6R8

  • GSK Investigational Site

    Mirabel, Quebec, J7J 2K8

  • GSK Investigational Site

    Québec, Quebec, G1E 7G9

  • GSK Investigational Site

    Québec, Quebec, G1W 4R4

  • GSK Investigational Site

    Sherbrooke, Quebec, J1J 2G2

  • GSK Investigational Site

    Toronto, Ontario, M4S 1Y2

  • GSK Investigational Site

    Toronto, Ontario, M9W 4L6

  • GSK Investigational Site

    Truro, Nova Scotia, B2N1L2

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 1M9

  • GSK Investigational Site

    Victoria, British Columbia, V8R 6R3

Other trials in Canada

Finland10 sites

  • GSK Investigational Site

    Espoo, 02230

  • GSK Investigational Site

    Helsinki, 00100

  • GSK Investigational Site

    Helsinki, 00930

  • GSK Investigational Site

    Jarvenpaa, 04400

  • GSK Investigational Site

    Kokkola, 67100

  • GSK Investigational Site

    Oulu, 90220

  • GSK Investigational Site

    Pori, 28100

  • GSK Investigational Site

    Seinäjoki, 60100

  • GSK Investigational Site

    Tampere, 33100

  • GSK Investigational Site

    Turku, 20520

Other trials in Finland

Sweden9 sites

  • GSK Investigational Site

    Borås, SE-506 30

  • GSK Investigational Site

    Gothenburg, SE-413 45

  • GSK Investigational Site

    Karlskrona

  • GSK Investigational Site

    Linköping, SE-58758

  • GSK Investigational Site

    Malmö, SE-211 52

  • GSK Investigational Site

    Örebro, SE-703 62

  • GSK Investigational Site

    Stockholm

  • GSK Investigational Site

    Upplands Vasby, SE-194 61

  • GSK Investigational Site

    Uppsala, SE-751 85

Other trials in Sweden

United States8 sites

  • GSK Investigational Site

    Bristol, Tennessee, 37620

  • GSK Investigational Site

    Charlotte, North Carolina, 28209

  • GSK Investigational Site

    Elkridge, Maryland, 21075

  • GSK Investigational Site

    Hickory, North Carolina, 28601

  • GSK Investigational Site

    Phoenix, Arizona, 85020

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15236

  • GSK Investigational Site

    Salt Lake City, Utah, 84106

  • GSK Investigational Site

    San Antonio, Texas, 78229

Other trials in United States

Japan6 sites

  • GSK Investigational Site

    Fukuoka, 810-0021

  • GSK Investigational Site

    Fukuoka, 812-0025

  • GSK Investigational Site

    Fukuoka, 813-8588

  • GSK Investigational Site

    Fukuoka, 816-0864

  • GSK Investigational Site

    Kanagawa, 224-8503

  • GSK Investigational Site

    Tokyo, 142-8666

Other trials in Japan

South Korea6 sites

  • GSK Investigational Site

    Ansan, 425-707

  • GSK Investigational Site

    Bucheon-si, 420-767

  • GSK Investigational Site

    Incheon, 400-711

  • GSK Investigational Site

    Kangwon-do, 220-701

  • GSK Investigational Site

    Seoul, 150-950

  • GSK Investigational Site

    Seoul, 152-703

Other trials in South Korea

France5 sites

  • GSK Investigational Site

    Angers, 49000

  • GSK Investigational Site

    Clermont-Ferrand, 63003

  • GSK Investigational Site

    Laval, 53000

  • GSK Investigational Site

    Mûrs-Erigné, 49610

  • GSK Investigational Site

    Rosiers-d'Égletons, 19300

Other trials in France

United Kingdom5 sites

  • GSK Investigational Site

    Belfast, BT7 2EB

  • GSK Investigational Site

    Bradford on Avon, Wiltshire, BA15 1DQ

  • GSK Investigational Site

    Broughshane, BT42 4JP

  • GSK Investigational Site

    Buckshaw Village, Chorley, Lancashire, PR7 7NA

  • GSK Investigational Site

    Liverpool, L22 0LG

Other trials in United Kingdom

Brazil4 sites

  • GSK Investigational Site

    Belo Horizonte, Minas Gerais, 30150-320

  • GSK Investigational Site

    Curitiba, Paraná, 80069-900

  • GSK Investigational Site

    São Paulo, 04266-010

  • GSK Investigational Site

    São Paulo, 05403-000

Other trials in Brazil

Taiwan4 sites

  • GSK Investigational Site

    Taichung, 40447

  • GSK Investigational Site

    Taipei, 10002

  • GSK Investigational Site

    Taipei, 112

  • GSK Investigational Site

    Taoyuan County, 333

Other trials in Taiwan

Australia3 sites

  • GSK Investigational Site

    Geelong, Victoria, 3220

  • GSK Investigational Site

    Warrawong, New South Wales, 2502

  • GSK Investigational Site

    Westmead, New South Wales, 2145

Other trials in Australia

Czechia3 sites

  • GSK Investigational Site

    Brno, 612 00

  • GSK Investigational Site

    České Budějovice, 370 05

  • GSK Investigational Site

    Hradec Králové, 500 05

Other trials in Czechia

Estonia2 sites

  • GSK Investigational Site

    Tallinn, 13619

  • GSK Investigational Site

    Tartu, 50106

Other trials in Estonia

Italy2 sites

  • GSK Investigational Site

    Genoa, Liguria, 16132

  • GSK Investigational Site

    Milan, Lombardy, 20127

Other trials in Italy

Hong Kong1 site

  • GSK Investigational Site

    Shatin, 000000

Other trials in Hong Kong

Mexico1 site

  • GSK Investigational Site

    Durango, 34000

Other trials in Mexico

About this study

Official title: A Phase 3b, Open-label, Multi-country, Multi-centre, Long-term Follow-up Study of ZOSTER-049 (Follow-up of ZOSTER-006/022 Studies) to Assess the Prophylactic Efficacy, Safety and Persistence of Immune Response of a Herpes Zoster Subunit Vaccine and Assessment of Persistence of Immune Response and Safety of 1 or 2 Additional Doses Administered in ZOSTER-049 in 2 Subgroups of Older Adults

The purpose of the current ZOSTER-101 long-term follow-up (LTFU) study of ZOSTER-049 (NCT02723773) study, an extension of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies, is to assess the long-term vaccine efficacy (VE) against Herpes Zoster (HZ) (approximately 11-15 years post primary vaccination in ZOSTER-006/022 studies), persistence of immunogenicity and safety of GSK's Herpes Zoster subunit (HZ/su) vaccine in older adults. The persistence of immunogenicity and safety of 1 or 2 additional doses (0, 2-month schedule) of HZ/su vaccine administered to a small group of participants in ZOSTER-049 study (approximately 5 years after the initial vaccination in ZOSTER-006/022 studies) will also be assessed.

Conditions
Herpes Zoster
Being tested
HZ/su vaccine
Keywords
Shingles, Herpes Zoster subunit vaccine, Recombinant Zoster Vaccine (RZV), Long-term follow-up study, Long-term vaccine efficacy, Prophylactic efficacy, Safety, Persistence of immune response, Older adults
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/su vaccineBiological

    No study intervention is administered in this extension study. Participants received the HZ/su vaccine administered in the ZOSTER-049 (NCT02723773), ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies. In order to assess the persistence of immune responses, participants provide blood samples at Day 1 and yearly from Month 12 until Month 48 in the current ZOSTER-101 study, according to their study group assignment. In case of a suspected HZ case diagnosis in any of the participants, clinical specimens from HZ lesions (3 replicate samples, collected on the same day, per participant) are collected to confirm the diagnosis of HZ by Polymerase Chain Reaction (PCR)

Study groups in NCT05371080
Study groupRoleWhat they receive
LTFU GroupOtherParticipants who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and are followed for long-term vaccine efficacy and safety in the current ZOSTER-101 study.
Receives: Biological: HZ/su vaccine
1-Additional Dose GroupOtherParticipants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and one additional dose of the HZ/su vaccine in the ZOSTER-049 study and are followed for persistence of immunogenicity and safety in the current ZOSTER-101 study.
Receives: Biological: HZ/su vaccine
Revaccination GroupOtherParticipants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and two additional doses of the HZ/su vaccine in the ZOSTER-049 study and are followed for persistence of immunogenicity and safety in the current ZOSTER-101 study.
Receives: Biological: HZ/su vaccine
Control GroupOtherParticipants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the ZOSTER-049 study, but who served as a control for the two groups that received 1 or 2 additional doses of HZ/su (1-Additional Dose and Revaccination groups). In the current ZOSTER-101 study, this Control group is used in the evaluation of the long-term vaccine efficacy, safety and as a control for persistence of immunogenicity to additional doses administered in ZOSTER-049 study.
Receives: Biological: HZ/su vaccine

What is being measured

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

  1. Number of participants in LTFU and Control groups with confirmed HZ cases

    A suspected case of HZ is defined as new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis.

    A suspected case of HZ can be confirmed in two ways:

    • By PCR;
    • By the HZ Ascertainment Committee (HZAC).

    Measured: During the total duration of ZOSTER-101 study (Day 1 through Month 48)

Secondary outcomes (6)

  1. Number of participants in LTFU and Control groups with confirmed HZ cases

    A suspected case of HZ is defined as new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis.

    A suspected case of HZ can be confirmed in two ways:

    • By PCR;
    • By the HZAC.

    Measured: From 1-month post-Dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER-101 study at Month 48

  2. Anti-glycoprotein E (gE) antibody concentrations

    Anti-gE antibody concentrations are expressed as geometric mean concentrations (GMCs), as determined by enzyme-linked immunosorbent assay (ELISA).

    Measured: At Day 1, Months 12, 24, 36 and 48 in the ZOSTER-101 study

  3. Frequency of gE-specific Cluster of Differentiation (CD)4+ T-cells secreting at least two activation markers from among IFN-γ, IL-2, TNF-α, CD40L

    Measured: At Day 1, Months 12, 24, 36 and 48 in the ZOSTER-101 study

  4. Percentage of participants with serious adverse events (SAEs) causally related to the study intervention

    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity. Relationship between study intervention and the occurrence of SAEs is assessed by the investigator using clinical judgement.

    Measured: During the total duration of the ZOSTER-101 study (Day 1 through Month 48)

  5. Percentage of participants with potential immune-mediated diseases (pIMDs) (serious and non-serious) causally related to the study intervention

    pIMDs are a subset of adverse events of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. A serious pIMD is any pIMD that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity. Relationship between study intervention and the occurrence of pIMDs is assessed by the investigator using clinical judgement.

    Measured: During the total duration of the ZOSTER-101 study (Day 1 through Month 48)

  6. Percentage of participants with HZ-related complications of confirmed HZ

    A suspected case of HZ is defined as new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis.

    A suspected case of HZ can be confirmed in two ways:

    • By PCR;
    • By the HZAC. HZ complications are the following: post-herpetic neuralgia, HZ vasculitis, disseminated disease, ophthalmic disease, neurologic disease, visceral disease or stroke A.

    Measured: During the total duration of the ZOSTER-101 study (Day 1 through Month 48)

Timeline

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

  1. First posted12 May 2022
  2. Study start10 Aug 2022
  3. Primary completion23 Aug 2027 (estimated)
  4. Study completion23 Aug 2027 (estimated)

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
Factorial
Model description
Interventional study model and allocation in the current study follow the same approach as presented in the primary studies.
Masking
None (open label)
Enrolment
3,038 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05371080
Sponsor's protocol ID
217917
Other IDs
2021-005319-30
Status last verified
Jan 2024
First submitted
9 May 2022
Last updated
18 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HZ/su vaccine in people with Herpes Zoster, run by GlaxoSmithKline at 107 sites in 18 countries.

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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in Germany, Spain, Canada, Finland, Sweden and 13 more countries. 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

Number of participants in LTFU and Control groups with confirmed HZ cases (time frame: During the total duration of ZOSTER-101 study (Day 1 through Month 48)). 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 NCT05371080.

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 18 Jan 2024.

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