Last updated: 01/17/2024 08:30:11
A study on the long-term efficacy, safety and persistence of immune response of a vaccine against Herpes Zoster in older adults
GSK study ID
217917
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Active, not recruiting
Active, not recruiting
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Factorial Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
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:
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
Anti-glycoprotein E (gE) antibody concentrations
Timeframe: At Day 1, Months 12, 24, 36 and 48 in the ZOSTER-101 study
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
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)
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)
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)
Interventions:
Biological/vaccine: HZ/su vaccine
Enrollment:
3038
Observational study model:
Not applicable
Primary completion date:
2027-23-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Not applicable
Study date(s)
August 2022 to August 2027
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
Status
Unmapped
Location
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30150-320
Status
Unmapped
Location
GSK Investigational Site
Bradford on Avon, Wiltshire, United Kingdom, BA15 1DQ
Status
Unmapped
Location
GSK Investigational Site
Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7NA
Status
Unmapped
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
Status
Unmapped
Location
GSK Investigational Site
Hickory, North Carolina, United States, 28601
Status
Unmapped
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Status
Unmapped
Location
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
Status
Unmapped
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Active, not recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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