Does Shingrix vaccination reduces the risk of stroke?

Proposal
5658

Title of Proposed Research

Lead Researcher

Benson Ogunjimi

Affiliation

University of Antwerp & Antwerp University Hospital

Funding Source

Potential Conflicts of Interest

Data Sharing Agreement Date

03 January 2019

Lay Summary

BackgroundVaricella-zoster virus (VZV) causes chickenpox, mainly during childhood, and remains afterwards in a sleeping state in the body. After awakening of the virus, VZV can cause a painful and debilitating disease called shingles. It has been known for some time that the risk of stroke in children is higher during the first six months following chickenpox. Moreover, several recent studies have also found an association between stroke and shingles.GSK has been developing a potent vaccine (Shingrix) against shingles.ObjectivesIn this study, we aim to assess whether the use of the Shingrix might not only reduce the risk of shingles, but potentially also the risk of stroke.

Study Data Provided

[{ "PostingID": 14523, "Title": "GSK-110390", "Description": "Efficacy, safety, and immunogenicity study of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A in adults aged 50 years or older" },{ "PostingID": 14524, "Title": "GSK-113077", "Description": "Efficacy, safety and immunogenicity study of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A in adults aged 70 years or older" }]

Statistical Analysis Plan

Publication Citation

Primary objective was whether stroke occurrence is affected by Shingrix looking at several time windows after vaccination(0-1, 0-2, 0-3 and 0-4). Therefore, a logistic regression using heart attract/strokes during the first year after vaccination as a dependent variable was performed. We only looked at the first year since adverse effects were only collected the first year. Thus the other time windows could not be considered. The model was adjusted for confounding factors such as: hypertension, gender, age, diabetes and race. We did not find a significant effect of the vaccine on the dependent variable. Significant effect was seen with variables age, diabetic, hypertension and gender.
We conclude that occurrence of a stroke is not affected by Shingrix.