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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

GlaxoSmithKline Biologicals

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20], Diseases [C] - Virus Diseases [C02]

Trial duration

8 Aug 2022 → ongoing

Decision date (initial)

2023-11-16

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

GlaxoSmithKline Biologicals

External identifiers

EU CT number

2023-505255-51-00

EudraCT number

2021-005319-30

ClinicalTrials.gov

NCT05371080

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the VE of HZ/su in preventing HZ.

Secondary objectives 4

1. 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.
2. To evaluate persistence of the humoral immune response to HZ/su.
3. To evaluate persistence of the cell-mediated immune response to HZ/su.
4. To evaluate vaccine safety of HZ/su.

Conditions and MedDRA coding

Herpes Zoster

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Participants, who, in the opinion of the investigator, can and are willing to comply with the requirements of the protocol (e.g. completion of the HZ-specific diary cards/QoL questionnaires, return for follow-up visits and ability to have scheduled contacts to allow evaluation during the study) or participants with a caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the HZ-specific diary cards, availability for follow-up contacts).
2. Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study specific procedure.
3. Medically stable participants as established by medical history and clinical examination before entering into the study.
4. Participants who completed ZOSTER-049 study (following at least 1 dose of HZ/su in ZOSTER-006/022 studies).

Exclusion criteria 4

1. Any clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
2. Use of any investigational or non-registered product (drug, vaccine or medical device) for the treatment of HZ or VZV infection at the time of enrolment or their planned use during the study period.
3. 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).
4. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Confirmed HZ cases during the total duration of the ZOSTER-101 study (Day 1 through Month 48).

Secondary endpoints 6

1. Confirmed HZ cases since 1-month post Dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER- 101 study.
2. Anti-gE antibody concentrations at Day 1*, Months 12, 24, 36 and 48 in ZOSTER-101 study.
3. Frequency of gE-specific CD4+ T-cells secreting at least 2 activation markers (from among IFN-γ, IL-2, TNF-α, CD40L) at Day 1*, Months 12, 24, 36 and 48 in ZOSTER-101 study.
4. Number and percentage of participants with SAEs which are assessed as causally related to the study intervention by the investigator during the total duration of the ZOSTER-101 study (Day 1 through Month 48).
5. Number and percentage of participants with pIMDs (serious and non-serious) which are assessed as causally related to the study intervention by the investigator during the total duration of the ZOSTER- 101 study (Day 1 through Month 48).
6. Number and percentage of participants with HZ-related complications of confirmed HZ during the total duration of the ZOSTER-101 study (Day 1 through Month 48).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

GlaxoSmithKline Biologicals

Sponsor organisation

GlaxoSmithKline Biologicals

Address

Rue De L'institut 89

City

Rixensart

Postcode

1330

Country

Belgium

Scientific contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trials Call Center

Public contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trials Call Center

Third parties 8

Locations

8 EU/EEA countries · 59 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 56 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

12 submissions — initial application plus substantial / non-substantial modifications