Herpes Zoster
Conditions
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
Brief 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 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.
Interventions
BIOLOGICALHZ/su vaccine
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)
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Interventional study model and allocation in the current study follow the same approach as presented in the primary studies.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants in LTFU and Control groups with confirmed HZ cases | 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
| Measure | Time frame | Description |
|---|---|---|
| Anti-glycoprotein E (gE) antibody concentrations | 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). |
| 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 | At Day 1, Months 12, 24, 36 and 48 in the ZOSTER-101 study | — |
| Number of participants in LTFU and Control groups with confirmed HZ cases | 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. |
| Percentage of participants with potential immune-mediated diseases (pIMDs) (serious and non-serious) causally related to the study intervention | 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. |
| Percentage of participants with HZ-related complications of confirmed HZ | 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. |
| Percentage of participants with serious adverse events (SAEs) causally related to the study intervention | 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. |
Countries
Australia, Brazil, Canada, Czechia, Estonia, Finland, France, Germany, Hong Kong, Italy, Japan, Mexico, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Outcome results
None listed