Study on Shingrix

+++ Update from October 16, 2020: The study was regularly ended on October 14, 2020, participation is no longer possible. +++

Since May 2018, a novel inactivated vaccine has been available on the German market (Shingrix, GlaxoSmithKline Biologicals SA) for the prevention of herpes zoster (HZ, shingles) and post-herpes neuralgia in persons of 50 years and older. The Drug Commission of the German Medical Association (DCGMA) and the Paul-Ehrlich-Institut, which is responsible for the monitoring of vaccines safety in Germany, have received various cases of suspected HZ as well as pronounced, partly blisterlike (bullous) skin reactions in close temporal relation to the vaccination with Shingrix.

As part of the observational study initiated at the Paul-Ehrlich-Institut, experts are attempting to establish whether the cases described above relate to the reactivation of the varicella zoster virus (VZV) as a potential adverse reaction of Shingrix. For this purpose, a number of suspected cases of HZ as well as bullous skin reactions shall be examined which are in close temporal relationship with the vaccination (case series). In doing so, samples shall be taken from the contents of the blisters if possible. The reference laboratory for varicella zoster virus and herpes simplex virus (HSV) infections will perform polymerase chain reactions (PCR) for VZV and, if required HSV as well as VZV typing (distinction between vaccine and wild type) in the event of a positive VCV result in the laboratory.

You are Invited to Help us with the Study – Report Suspected Cases

The Paul-Ehrlich-Institut is asking doctors to participate in the study (Begin 15.04.2020). Costs for virological and diagnostic examination of the skin reactions in the reference laboratory and shipment of the sample material will be borne by the PEI. In addition, we are requesting you to provide a pseudonymised documentation of the clinical course. The Paul-Ehrlich-Institut will also compensate for the workload arising from this.

We are requesting you to contact us in the event of a suspected case of HZ and/or a bullous skin reaction in close temporal connection with the vaccination against HZ using the vaccine Shingrix.

Let us take this opportunity to thank you very much in advance for your support.

The study was approved by the local ethics committee.