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NCT Number: NCT05371080

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

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Warrawong, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

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.

Treatment and study plan

HZ/su vaccine

Biological

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)

Primary outcomes

  1. 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)

    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).

Secondary outcomes

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

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

    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.

  2. Anti-glycoprotein E (gE) antibody concentrations

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

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

  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

    Time frame: 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

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

    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.

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

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

    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.

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

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

    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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 12, 2022
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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