ZOSTER-101
Research type
Research Study
Full 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
IRAS ID
1005964
Contact name
Agnes Mwakingwe-Omari
Contact email
Sponsor organisation
GlaxoSmithKline Biologicals
Eudract number
2021-005319-30
Clinicaltrials.gov Identifier
Research summary
Shingles, also known as Herpes Zoster is a disease that is caused by the same virus that causes chickenpox. After getting chickenpox during childhood, the virus remains dormant in the body. Shingles occurs when the virus becomes active again after many years. This happens when the body’s defences against infection become weaker. The chance of this happening increases as we become older, especially over the age of 50. Our body’s defences can also become weak at any age if we have certain diseases or if we take certain medicines.
Shingrix is a GlaxoSmithKline Biologicals’ (GSK) vaccine. It is given to older adults to protect against shingles. It is also given to younger adults who have weakened body defences, to protect against the shingles virus. This vaccine has been shown to protect against or increase the body’s ability to fight off shingles. The vaccine is approved in different countries across the world.
The purpose of this clinical research study is to assess the long-term efficacy, safety and persistence of immune response of the vaccine Shingrix against Herpes Zoster in older adults.
To assess the persistence of immune responses, participants provide blood samples at Day 1 and yearly from Month 12 until Month 48 in the current ZOSTER-101 study, according to their study group assignment.
All participants who completed the ZOSTER-049 study, and who confirm their interest to enrol in the ZOSTER-101 study at participating centres, will be considered for entry in study ZOSTER-101.
Approximately 3662 participants will participate worldwide with approximately 206 patients across 5 sites in the UK, which will last for approximately 5 years. This is a rollover extension study. The Sponsor of this study, GlaxoSmithKline Biologicals.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
22/NW/0282
Date of REC Opinion
13 Oct 2022
REC opinion
Further Information Favourable Opinion