AIV - FISABIO Impact and risk of Herpes Zoster in immunosuppressed subjects in Valencia Region, Spain

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30801
• EU PAS number:
  EUPAS30792
• Study ID:
  30801
• Official title and acronym:
  AIV - FISABIO Impact and risk of Herpes Zoster in immunosuppressed subjects in Valencia Region, Spain
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Herpes Zoster is a disease caused by the reactivation of the varicella-zoster virus in situations of decreased cellular immunity. Among the patients with the highest risk of suffering an HZ are patients with advanced age and immunosuppression of different origin and grade. These subjects would be beyond the scope of the only vaccine that currently exists on the market, as it is a live attenuated virus vaccine. An alternative to this type of vaccine is the inactivated subunit vaccine (glycoprotein E). Primary objective: Estimate the incidence of HZ in immunosuppressed subjects ≥ 18 years in the Valencian Community, between 2009 and 2014, both globally and stratifying by age groups, sex and type of immunodeficiency. Secondary: Estimate the risk of HZ in immunocompromised subjects compared to immunocompetent subjects, compare the consumption of health resources, the risk of complications and the risk of recurrent HZ. To study the impact of HZ on the underlying pathology (immunosuppression), comparing the six months prior to the first diagnosis of HZ with the six months after said diagnosis. To study the risk of HZ and the consumption of resources in immunocompromised patients in comorbidity with diabetes and / or chronic obstructive pulmonary disease and / or heart failure and / or chronic kidney disease, compared to immunocompetent subjects. To estimate the prevalence of immunosuppressive conditions in the general population prior to the first diagnosis of HZ with the six months after that diagnosis. To study the risk of HZ and the consumption of resources in immunocompromised patients in comorbidity with diabetes and / or chronic obstructive pulmonary disease and / or heart failure and / or chronic kidney disease, compared to immunocompetent subjects. Estimate the risk of suffering a recurrent HZ in immunocompromised and immunocompetent subjects. Estimate the prevalence of immunosuppressive conditions in the general population.
• Study status:
  Finalised

Research institution and networks

Institutions

The Foundation for the Promotion of Health and Biomedical Research of Valencia Region (FISABIO)

Spain

Study timelines

Date when funding contract was signed

Actual: 27/01/2017

Study start date

Actual: 27/02/2017

Date of final study report

Actual: 27/09/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GSK

Study protocol

Initial protocol

AIV - FISABIO_HZ_2017_04_IHZIS_JDD

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable