Status: Finalised First registered on: 02/08/2019
Last updated on: 02/08/2019
1. Study identification
EU PAS Register NumberEUPAS30792
Official titleAIV - FISABIO Impact and risk of Herpes Zoster in immunosuppressed subjects in Valencia Region, Spain
Study title acronym
Study typeObservational study
Brief description of the studyHerpes 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameFISABIO
Centre locationValencia
Details of (Primary) lead investigator
Title Dr
Last name Diez-Domingo
First name Javier
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed27/01/2017
Start date of data collection27/02/2017
Start date of data analysis
Date of interim report, if expected
Date of final study report27/09/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesGSK100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Diez-Domingo
First name Javier
Address line 1Avenida Cataluña 21
Address line 2 
Address line 3 
CityValencia 
Postcode 
CountrySpain
Phone number (incl. country code)0034961925968 
Alternative phone number 
Fax number (incl. country code) 
Email address diez_jav@gva.es
Public Enquiries
Title Dr 
Last name Diez-Domingo 
First name Javier 
Address line 1Avenida Cataluña 21 
Address line 2 
Address line 3 
CityValencia 
Postcode 
CountrySpain 
Phone number (incl. country code)0034961925968 
Alternative phone number 
Fax number (incl. country code) 
Email address diez_jav@gva.es 
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