Herpes Zoster Hospitalizations in Italy

NCT05952271 | Unknown DMC

• 1 other identifier: 14112
• Study Type: observational
• Target: 72,000
• Locations: 1 country
• Sites: 1

Brief Summary

In Italy, the 2017-2019 National Immunization Plan recommended specific vaccinations for the elderly, defined as those 65 years old and older, and at-risk adults with age 50+ (adults presenting cardiovascular, respiratory, or metabolic diseases, immunodepression, etc.). However, the coverage target set by the Plan (50% for Herpes Zoster vaccination in 2019) was not reached. Providing additional data on the incidence of Herpes Zoster could improve the risks perception of the disease and the vaccination uptake. The present study will aim to describe a full picture of Herpes Zoster associated hospital admissions in Italy, focusing on co-morbidities which induce reduced varicella-zoster virus-specific cell-mediated immunity response. Furthermore, as varicella-zoster virus reactivation was reported in COVID-19-positive patients, a deepening on a possible relationship between the two infections will be investigated.

Conditions

Herpes Zoster; Comorbidities and Coexisting Conditions

Keywords

Herpes Zoster; Vaccination; Hospitalizations; Comorbidities

Outcome Measures

Primary Outcomes (1)

• Co-morbidities among Herpes Zoster hospitalizations

  Rate of patients hospitalized for Herpes Zoster with co-morbidities

  2011-2021

Secondary Outcomes (4)

• Shingles annual hospitalization rates

  2011-2021

• Shingles hospitalization rates by age classes

  2011-2021

• Herpes Zoster and COVID-19 infection

  2020-2021

• Risk factors associated to deaths, a longer length of stay in hospital or the presence of zoster-complications among Herpes Zoster-related hospitalizations in the entire Italian general adult population

  2011-2021

Interventions

Hospitalization OTHER

Population of patients hospitalized for Herpes Zoster (ICD9-CM 053.xx)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital discharge records for Herpes Zoster between 2011 and 2021, with or without complications, will be extracted from the national hospital discharge database (HDD). The characteristics of hospitalizations will be described for the 18 years of age and older adults (2011-2021 years). The characteristics of hospitalizations in 2020-21 will be described in patients with or without concomitant COVID-19 infection

You may qualify if:

• Hospital discharge records for Herpes Zoster infection in primary diagnosis age ≥18 years
• Hospital discharge records for Herpes Zoster infection in secondary diagnoses age ≥18 years

You may not qualify if:

• Hospital discharge records for Herpes Zoster infection in primary diagnosis age \<18 years
• Hospital discharge records for Herpes Zoster infection in secondary diagnoses age \<18 years

Sponsors & Collaborators

• University of L'Aquila: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of L'Aquila

L’Aquila, 67100, Italy

RECRUITING

Related Publications (19)

• Gabutti G, Franco E, Bonanni P, Conversano M, Ferro A, Lazzari M, Maggi S, Rossi A, Scotti S, Vitale F, Volpi A, Greco D. Reducing the burden of Herpes Zoster in Italy. Hum Vaccin Immunother. 2015;11(1):101-7. doi: 10.4161/hv.34363. Epub 2014 Nov 1.

  PMID: 25483522 BACKGROUND

• Grose C. Varicella vaccination of children in the United States: assessment after the first decade 1995-2005. J Clin Virol. 2005 Jun;33(2):89-95; discussion 96-8. doi: 10.1016/j.jcv.2005.02.003.

  PMID: 15911422 BACKGROUND

• Gabutti G, Serenelli C, Cavallaro A, Ragni P. Herpes zoster associated hospital admissions in Italy: review of the hospital discharge forms. Int J Environ Res Public Health. 2009 Sep;6(9):2344-53. doi: 10.3390/ijerph6092344. Epub 2009 Sep 2.

  PMID: 19826547 BACKGROUND

• Koshy E, Mengting L, Kumar H, Jianbo W. Epidemiology, treatment and prevention of herpes zoster: A comprehensive review. Indian J Dermatol Venereol Leprol. 2018 May-Jun;84(3):251-262. doi: 10.4103/ijdvl.IJDVL_1021_16.

  PMID: 29516900 BACKGROUND

• Gialloreti LE, Merito M, Pezzotti P, Naldi L, Gatti A, Beillat M, Serradell L, di Marzo R, Volpi A. Epidemiology and economic burden of herpes zoster and post-herpetic neuralgia in Italy: a retrospective, population-based study. BMC Infect Dis. 2010 Aug 3;10:230. doi: 10.1186/1471-2334-10-230.

  PMID: 20682044 BACKGROUND

• Stein AN, Britt H, Harrison C, Conway EL, Cunningham A, Macintyre CR. Herpes zoster burden of illness and health care resource utilisation in the Australian population aged 50 years and older. Vaccine. 2009 Jan 22;27(4):520-9. doi: 10.1016/j.vaccine.2008.11.012. Epub 2008 Nov 21.

  PMID: 19027048 BACKGROUND

• Di Legami V, Gianino MM, Ciofi degli Atti M, Massari M, Migliardi A, Tomba GS, Zotti C; Zoster Study Group. Epidemiology and costs of herpes zoster: background data to estimate the impact of vaccination. Vaccine. 2007 Oct 23;25(43):7598-604. doi: 10.1016/j.vaccine.2007.07.049. Epub 2007 Aug 15.

  PMID: 17889410 BACKGROUND

• Diez-Domingo J, Weinke T, Garcia de Lomas J, Meyer CU, Bertrand I, Eymin C, Thomas S, Sadorge C. Comparison of intramuscular and subcutaneous administration of a herpes zoster live-attenuated vaccine in adults aged >/=50 years: a randomised non-inferiority clinical trial. Vaccine. 2015 Feb 4;33(6):789-95. doi: 10.1016/j.vaccine.2014.12.024. Epub 2014 Dec 30.

  PMID: 25555381 BACKGROUND

• Pinchinat S, Cebrian-Cuenca AM, Bricout H, Johnson RW. Similar herpes zoster incidence across Europe: results from a systematic literature review. BMC Infect Dis. 2013 Apr 10;13:170. doi: 10.1186/1471-2334-13-170.

  PMID: 23574765 BACKGROUND

• Nardone A, de Ory F, Carton M, Cohen D, van Damme P, Davidkin I, Rota MC, de Melker H, Mossong J, Slacikova M, Tischer A, Andrews N, Berbers G, Gabutti G, Gay N, Jones L, Jokinen S, Kafatos G, de Aragon MV, Schneider F, Smetana Z, Vargova B, Vranckx R, Miller E. The comparative sero-epidemiology of varicella zoster virus in 11 countries in the European region. Vaccine. 2007 Nov 7;25(45):7866-72. doi: 10.1016/j.vaccine.2007.07.036. Epub 2007 Aug 8.

  PMID: 17919788 BACKGROUND

• Calabro GE, Tognetto A, Carini E, Mancinelli S, Sarnari L, Colamesta V, Ricciardi W, de Waure C. Strategies to Improve Vaccination among At-Risk Adults and the Elderly in Italy. Vaccines (Basel). 2020 Jul 4;8(3):358. doi: 10.3390/vaccines8030358.

  PMID: 32635467 BACKGROUND

• Valente N, Cocchio S, Stefanati A, Baldovin T, Martinelli D, Prato R, Baldo V, Gabutti G. Temporal trends in herpes zoster-related hospitalizations in Italy, 2001-2013: differences between regions that have or have not implemented varicella vaccination. Aging Clin Exp Res. 2017 Aug;29(4):771-779. doi: 10.1007/s40520-017-0782-z. Epub 2017 Jun 12.

  PMID: 28608255 BACKGROUND

• Tartari F, Spadotto A, Zengarini C, Zanoni R, Guglielmo A, Adorno A, Valzania C, Pileri A. Herpes zoster in COVID-19-positive patients. Int J Dermatol. 2020 Aug;59(8):1028-1029. doi: 10.1111/ijd.15001. Epub 2020 Jun 12. No abstract available.

  PMID: 32530063 BACKGROUND

• Thomas SL, Hall AJ. What does epidemiology tell us about risk factors for herpes zoster? Lancet Infect Dis. 2004 Jan;4(1):26-33. doi: 10.1016/s1473-3099(03)00857-0.

  PMID: 14720565 BACKGROUND

• Esteban-Vasallo MD, Dominguez-Berjon MF, Gil-Prieto R, Astray-Mochales J, Gil de Miguel A. Sociodemographic characteristics and chronic medical conditions as risk factors for herpes zoster: a population-based study from primary care in Madrid (Spain). Hum Vaccin Immunother. 2014;10(6):1650-60. doi: 10.4161/hv.28620. Epub 2014 May 7.

  PMID: 24805130 BACKGROUND

• Nimmo A, Steenkamp R, Ravanan R, Taylor D. Do routine hospital data accurately record comorbidity in advanced kidney disease populations? A record linkage cohort study. BMC Nephrol. 2021 Mar 17;22(1):95. doi: 10.1186/s12882-021-02301-5.

  PMID: 33731041 BACKGROUND

• Humphries KH, Rankin JM, Carere RG, Buller CE, Kiely FM, Spinelli JJ. Co-morbidity data in outcomes research: are clinical data derived from administrative databases a reliable alternative to chart review? J Clin Epidemiol. 2000 Apr;53(4):343-9. doi: 10.1016/s0895-4356(99)00188-2.

  PMID: 10785564 BACKGROUND

• Kim YJ, Lee CN, Lee MS, Lee JH, Lee JY, Han K, Park YM. Recurrence Rate of Herpes Zoster and Its Risk Factors: a Population-based Cohort Study. J Korean Med Sci. 2018 Dec 20;34(2):e1. doi: 10.3346/jkms.2019.34.e1. eCollection 2019 Jan 14.

  PMID: 30636941 BACKGROUND

• Fiasca F, Necozione S, Fabiani L, Mastrodomenico M, Mattei A. Measles-Related Hospitalizations in Italy, 2004-2016: The Importance of High Vaccination Coverage. Ann Glob Health. 2019 Mar 19;85(1):40. doi: 10.5334/aogh.2455.

  PMID: 30896136 BACKGROUND

MeSH Terms

Conditions

Herpes Zoster

Interventions

Hospitalization

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Antonella Mattei, PhD

  University of L'Aquila

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonella Mattei, PhD

CONTACT

+390862434651; antonella.mattei@univaq.it

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 19, 2023
• Study Start: October 26, 2023
• Primary Completion: April 1, 2024
• Study Completion: July 30, 2025
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)