A study on the long-term efficacy, safety and persistence of immune response of a vaccine against Herpes Zoster in older adults

Phase 1

• Conditions: Vaccination against HZ and its related complications in adults older than 50 years (at the time of primary vaccination).; MedDRA version: 20.0Level: PTClassification code 10019974Term: Herpes zosterSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 21.1Level: PTClassification code 10036376Term: Post herpetic neuralgiaSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.1Level: PTClassification code 10030865Term: Ophthalmic herpes zosterSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: PTClassification code 10063491Term: Herpes zoster oticusSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 21.1Level: PTClassification code 10075611Term: Varicella zoster virus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: PTClassification code 10074297Term: Herpes zoster cutaneous disseminatedSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 23.1Level: PTClassification code 10080516Term: Herpes zoster reactivationSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 23.1Level: PTClassification code 10084396Term: Disseminated varicella zoster virus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: PTClassification code 10072210Term: Genital herpes zosterSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2021-005319-30-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-06
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5302

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 of 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 662
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3000

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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the vaccine efficacy (VE) of HZ/su in preventing HZ.;Secondary Objective: • To evaluate the VE of HZ/su in preventing HZ from 1-month post Dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER-101 study.<br>• To evaluate persistence of the humoral immune response to HZ/su.<br>• To evaluate persistence of the cell-mediated immune response to HZ/su.<br>• To evaluate vaccine safety of HZ/su.<br>;Primary end point(s): Number of participants in LTFU and Control groups with confirmed HZ cases;Timepoint(s) of evaluation of this end point: During the total duration of ZOSTER-101 study (Day 1 through Month 48)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Number of participants in LTFU and Control groups with confirmed HZ cases<br>2. Anti-glycoprotein E (gE) antibody concentrations <br>3. 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<br>4. Percentage of participants with serious adverse events (SAEs) causally related to the study intervention<br>5. Percentage of participants with potential immune-mediated diseases (pIMDs) (serious and non-serious) causally related to the study intervention<br>6. Percentage of participants with HZ-related complications of confirmed HZ ;Timepoint(s) of evaluation of this end point: 1. From 1-month post-Dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER-101 study at Month 48<br>2, 3. At Day 1, Months 12, 24, 36 and 48 in the ZOSTER-101 study<br>4, 5, 6. During the total duration of the ZOSTER-101 study (Day 1 through Month 48)