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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05371080




Registration number
NCT05371080
Ethics application status
Date submitted
9/05/2022
Date registered
12/05/2022

Titles & IDs
Public title
A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults
Scientific 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
Secondary ID [1] 0 0
2021-005319-30
Secondary ID [2] 0 0
217917
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Herpes Zoster 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - HZ/su vaccine

Other: LTFU Group - Participants 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.

Other: 1-Additional Dose Group - Participants 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.

Other: Revaccination Group - Participants 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.

Other: Control Group - Participants 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.


Treatment: Other: HZ/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)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants in LTFU and Control groups with confirmed HZ cases
Timepoint [1] 0 0
During the total duration of ZOSTER-101 study (Day 1 through Month 48)
Secondary outcome [1] 0 0
Number of participants in LTFU and Control groups with confirmed HZ cases
Timepoint [1] 0 0
From 1-month post-Dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER-101 study at Month 48
Secondary outcome [2] 0 0
Anti-glycoprotein E (gE) antibody concentrations
Timepoint [2] 0 0
At Day 1, Months 12, 24, 36 and 48 in the ZOSTER-101 study
Secondary outcome [3] 0 0
Frequency of gE-specific Cluster of Differentiation (CD)4+ T-cells secreting at least two activation markers from among IFN-?, IL-2, TNF-a, CD40L
Timepoint [3] 0 0
At Day 1, Months 12, 24, 36 and 48 in the ZOSTER-101 study
Secondary outcome [4] 0 0
Percentage of participants with serious adverse events (SAEs) causally related to the study intervention
Timepoint [4] 0 0
During the total duration of the ZOSTER-101 study (Day 1 through Month 48)
Secondary outcome [5] 0 0
Percentage of participants with potential immune-mediated diseases (pIMDs) (serious and non-serious) causally related to the study intervention
Timepoint [5] 0 0
During the total duration of the ZOSTER-101 study (Day 1 through Month 48)
Secondary outcome [6] 0 0
Percentage of participants with HZ-related complications of confirmed HZ
Timepoint [6] 0 0
During the total duration of the ZOSTER-101 study (Day 1 through Month 48)

Eligibility
Key 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).
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/08/2027
Actual
Sample size
Target
3038
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Warrawong
Recruitment hospital [2] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [3] 0 0
GSK Investigational Site - Geelong
Recruitment postcode(s) [1] 0 0
2502 - Warrawong
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Utah
Country [8] 0 0
Brazil
State/province [8] 0 0
Minas Gerais
Country [9] 0 0
Brazil
State/province [9] 0 0
Paraná
Country [10] 0 0
Brazil
State/province [10] 0 0
São Paulo
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Nova Scotia
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Czechia
State/province [15] 0 0
Brno
Country [16] 0 0
Czechia
State/province [16] 0 0
Ceske Budejovice
Country [17] 0 0
Czechia
State/province [17] 0 0
Hradec Kralove
Country [18] 0 0
Estonia
State/province [18] 0 0
Tallinn
Country [19] 0 0
Estonia
State/province [19] 0 0
Tartu
Country [20] 0 0
Finland
State/province [20] 0 0
Espoo
Country [21] 0 0
Finland
State/province [21] 0 0
Helsinki
Country [22] 0 0
Finland
State/province [22] 0 0
Jarvenpaa
Country [23] 0 0
Finland
State/province [23] 0 0
Kokkola
Country [24] 0 0
Finland
State/province [24] 0 0
Oulu
Country [25] 0 0
Finland
State/province [25] 0 0
Pori
Country [26] 0 0
Finland
State/province [26] 0 0
Seinajoki
Country [27] 0 0
Finland
State/province [27] 0 0
Tampere
Country [28] 0 0
Finland
State/province [28] 0 0
Turku
Country [29] 0 0
France
State/province [29] 0 0
Angers
Country [30] 0 0
France
State/province [30] 0 0
Clermont-Ferrand
Country [31] 0 0
France
State/province [31] 0 0
Laval
Country [32] 0 0
France
State/province [32] 0 0
Murs Erigne
Country [33] 0 0
France
State/province [33] 0 0
Rosiers d'Egletons
Country [34] 0 0
Germany
State/province [34] 0 0
Baden-Wuerttemberg
Country [35] 0 0
Germany
State/province [35] 0 0
Bayern
Country [36] 0 0
Germany
State/province [36] 0 0
Hessen
Country [37] 0 0
Germany
State/province [37] 0 0
Nordrhein-Westfalen
Country [38] 0 0
Germany
State/province [38] 0 0
Rheinland-Pfalz
Country [39] 0 0
Germany
State/province [39] 0 0
Sachsen-Anhalt
Country [40] 0 0
Germany
State/province [40] 0 0
Sachsen
Country [41] 0 0
Germany
State/province [41] 0 0
Berlin
Country [42] 0 0
Germany
State/province [42] 0 0
Hamburg
Country [43] 0 0
Hong Kong
State/province [43] 0 0
Shatin
Country [44] 0 0
Italy
State/province [44] 0 0
Liguria
Country [45] 0 0
Italy
State/province [45] 0 0
Lombardia
Country [46] 0 0
Japan
State/province [46] 0 0
Fukuoka
Country [47] 0 0
Japan
State/province [47] 0 0
Kanagawa
Country [48] 0 0
Japan
State/province [48] 0 0
Tokyo
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Ansan
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Bucheon-si,
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Incheon
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Kangwon-do
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Seoul
Country [54] 0 0
Mexico
State/province [54] 0 0
Durango
Country [55] 0 0
Spain
State/province [55] 0 0
Balenyà (Barcelona)
Country [56] 0 0
Spain
State/province [56] 0 0
Barcelona
Country [57] 0 0
Spain
State/province [57] 0 0
Centelles (Barcelona)
Country [58] 0 0
Spain
State/province [58] 0 0
La Roca del Vallès
Country [59] 0 0
Spain
State/province [59] 0 0
Madrid
Country [60] 0 0
Spain
State/province [60] 0 0
Majadahonda( Madrid
Country [61] 0 0
Spain
State/province [61] 0 0
Marid
Country [62] 0 0
Spain
State/province [62] 0 0
Peralada( Girona)
Country [63] 0 0
Spain
State/province [63] 0 0
Valencia
Country [64] 0 0
Spain
State/province [64] 0 0
Vic
Country [65] 0 0
Sweden
State/province [65] 0 0
Borås
Country [66] 0 0
Sweden
State/province [66] 0 0
Göteborg
Country [67] 0 0
Sweden
State/province [67] 0 0
Karlskrona
Country [68] 0 0
Sweden
State/province [68] 0 0
Linköping
Country [69] 0 0
Sweden
State/province [69] 0 0
Malmö
Country [70] 0 0
Sweden
State/province [70] 0 0
Stockholm
Country [71] 0 0
Sweden
State/province [71] 0 0
Upplands Väsby
Country [72] 0 0
Sweden
State/province [72] 0 0
Uppsala
Country [73] 0 0
Sweden
State/province [73] 0 0
Örebro
Country [74] 0 0
Taiwan
State/province [74] 0 0
Taichung
Country [75] 0 0
Taiwan
State/province [75] 0 0
Taipei
Country [76] 0 0
Taiwan
State/province [76] 0 0
Taoyuan County
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Lancashire
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Wiltshire
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Belfast
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Broughshane
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05371080