Zoster vaccine effectiveness against incident herpes zoster and post-herpetic neuralgia in elderly in England

Study type
Protocol
Date of Approval
Study reference ID
17_081
Lay Summary

Shingles, also called zoster or herpes zoster, is a painful rash. Almost 1 out of every 3 people will develop shingles in their lifetime. The risk and severity of shingles increases with age. The most common complication of shingles is post-herpetic neuralgia, which is a long-lasting pain that can last for months after the rash.

In 2013, a vaccine to prevent shingles was made available in the UK to older adults in their 70s. Based on clinical trials, the vaccine was shown to prevent shingles disease and lessen its effects. However, clinical trials study the effects of vaccines in selected populations under controlled conditions. It is therefore important to study the effects of vaccination in unselected populations in routine clinical use.

With this study, we aim to assess how well the vaccine works in real-life by estimating the amount of shingles disease among elderly that has been prevented through introducing the zoster vaccine in the UK in 2013.

Technical Summary

Herpes zoster (HZ) is characterized by a unilateral dermatomal rash and pain. The most common complication is post-herpetic neuralgia (PHN).The UK introduced Zostavax in the national immunization program in 2013. The vaccine was routinely offered to 70 year-olds and, as part of the catch-up, to 79 year-olds.

Until now, the vaccine effectiveness has not been studied in the UK general population. We will perform a cohort study, aiming to estimate the effectiveness of zoster vaccination against incident HZ and PHN in elderly in England. Particularly, we propose a cohort study based on health-records of the CPRD population eligible for linkage with HES APC databases and belonging to the birth cohorts: 1943-1946 (routine) and 1934-1937 (catch-up). We will estimate vaccination coverage by birth cohort over time, incidence rates of HZ, PHN and HZ complications and vaccine effectiveness against HZ/PHN and HZ complications. We will additionally explore risk factors for vaccine failure. We will use a Poisson regression model with interaction effects between risk factors of interest and vaccination status as it would allow disentangling HZ/PHN risk factors and risk factors for vaccine failure.
This study will provide evidence on the effectiveness of Zostavax, and might be helpful in optimizing immunization programs.

Health Outcomes to be Measured

Herpes zoster
- Post-herpetic neuralgia
- Other herpes zoster complications

Collaborators

Kaatje Bollaerts - Chief Investigator - P95
Kaatje Bollaerts - Corresponding Applicant - P95
Germano Ferreira - Collaborator - Not from an Organisation
Margarita Riera-Montes - Collaborator - P95
Maria Alexandridou - Collaborator - P95
Thomas Verstraeten - Collaborator - P95

Linkages

HES Admitted Patient Care;HES Admitted Patient Care;Patient Level Index of Multiple Deprivation;Patient Level Index of Multiple Deprivation