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Does Shingrix vaccination reduces the risk of stroke?
Proposal
5658
Title of Proposed Research
Does Shingrix vaccination reduces the risk of stroke?
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
GSK-110390
: Efficacy, safety, and immunogenicity study of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A in adults aged 50 years or older
GSK-113077
: Efficacy, safety and immunogenicity study of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A in adults aged 70 years or older
Statistical Analysis Plan
We will use a multiple logistic regression analysis (see e.g. Ogunjimi et al, J Infection, 2014) to assess whether the occurrence of stroke has been affected by the receipt of Shingrix (odds ratio).We will of course take demographics and known risk factors (if available) into account such as hypertension, etc in order to control for confounding covariates. We will take several time windows following vaccination into account (0-1y, 0-2y, 0-3y). Given that we don't know the incidence of stroke in this population we can not calculate the power of this study at this moment.If possible we would like to differentiate between ischemic and other types of stroke in a secondary analysis. If the data is available, we could also assess in a tertiary analysis whether acute myocardial infarction has been affected by Shingrix vaccination.
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.
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