A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults

GlaxoSmithKline (GSK)

Status and phase: Active, not recruiting; Phase 3

Conditions: Herpes Zoster

Treatments: Biological: HZ/su vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05371080

2021-005319-30 (EudraCT Number)

217917

Details and patient eligibility

About

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.

Enrollment: 3,038 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

3,038 participants in 4 patient groups

LTFU Group

Other group

Description:

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.

Treatment:

Biological: HZ/su vaccine

1-Additional Dose Group

Other group

Description:

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.

Treatment:

Biological: HZ/su vaccine

Revaccination Group

Other group

Description:

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.

Treatment:

Biological: HZ/su vaccine

Control Group

Other group

Description:

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:

Biological: HZ/su vaccine