Clinical trial NCT05371080: A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Herpes Zoster
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
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2022-05-12
Enrollment: 3038
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Interventional study model and allocation in the current study follow the same approach as presented in the primary studies.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants in LTFU and Control groups with confirmed HZ cases
timeFrame: During the total duration of ZOSTER-101 study (Day 1 through Month 48)
Secondary outcomes:
measure: Number of participants in LTFU and Control groups with confirmed HZ cases
timeFrame: From 1-month post-Dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER-101 study at Month 48
measure: Anti-glycoprotein E (gE) antibody concentrations
timeFrame: At Day 1, Months 12, 24, 36 and 48 in the ZOSTER-101 study
measure: 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
timeFrame: At Day 1, Months 12, 24, 36 and 48 in the ZOSTER-101 study
measure: Percentage of participants with serious adverse events (SAEs) causally related to the study intervention
timeFrame: During the total duration of the ZOSTER-101 study (Day 1 through Month 48)
measure: Percentage of participants with potential immune-mediated diseases (pIMDs) (serious and non-serious) causally related to the study intervention
timeFrame: During the total duration of the ZOSTER-101 study (Day 1 through Month 48)
measure: Percentage of participants with HZ-related complications of confirmed HZ
timeFrame: During the total duration of the ZOSTER-101 study (Day 1 through Month 48)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Elkridge
country: United States
facility: GSK Investigational Site
state: Maryland
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Bristol
country: United States
facility: GSK Investigational Site
state: Tennessee
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Warrawong
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Westmead
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Geelong
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Belo Horizonte
country: Brazil
facility: GSK Investigational Site
state: Minas Gerais
city: Curitiba
country: Brazil
facility: GSK Investigational Site
state: Paraná
city: São Paulo
country: Brazil
facility: GSK Investigational Site
city: São Paulo
country: Brazil
facility: GSK Investigational Site
city: Vancouver
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Truro
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mirabel
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Québec City
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: GSK Investigational Site
city: Brno
country: Czechia
facility: GSK Investigational Site
city: Ceske Budejovice
country: Czechia
facility: GSK Investigational Site
city: Hradec Kralove
country: Czechia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Espoo
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Jarvenpaa
country: Finland
facility: GSK Investigational Site
city: Kokkola
country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
facility: GSK Investigational Site
city: Pori
country: Finland
facility: GSK Investigational Site
city: Seinajoki
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Angers
country: France
facility: GSK Investigational Site
city: Clermont-Ferrand
country: France
facility: GSK Investigational Site
city: Laval
country: France
facility: GSK Investigational Site
city: Murs Erigne
country: France
facility: GSK Investigational Site
city: Rosiers d'Egletons
country: France
facility: GSK Investigational Site
city: Wangen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Weinheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Rednitzhembach
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wallerfing
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Floersheim
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Goch
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Witten
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Magdeburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Freiberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Shatin
country: Hong Kong
facility: GSK Investigational Site
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Ansan
country: Korea, Republic of
facility: GSK Investigational Site
city: Bucheon-si,
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Kangwon-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Durango
country: Mexico
facility: GSK Investigational Site
city: Balenyà (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Centelles (Barcelona)
country: Spain
facility: GSK Investigational Site
city: La Roca del Vallès
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Majadahonda( Madrid
country: Spain
facility: GSK Investigational Site
city: Marid
country: Spain
facility: GSK Investigational Site
city: Peralada( Girona)
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Vic
country: Spain
facility: GSK Investigational Site
city: Borås
country: Sweden
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Karlskrona
country: Sweden
facility: GSK Investigational Site
city: Linköping
country: Sweden
facility: GSK Investigational Site
city: Malmö
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Upplands Väsby
country: Sweden
facility: GSK Investigational Site
city: Uppsala
country: Sweden
facility: GSK Investigational Site
city: Örebro
country: Sweden
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taoyuan County
country: Taiwan
facility: GSK Investigational Site
city: Buckshaw Village, Chorley
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Bradford on Avon
country: United Kingdom
facility: GSK Investigational Site
state: Wiltshire
city: Belfast
country: United Kingdom
facility: GSK Investigational Site
city: Broughshane
country: United Kingdom
facility: GSK Investigational Site
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: