Herpes ZosterNCT05952271
Herpes Zoster Hospitalizations in Italy
An observational study of Herpes Zoster and Comorbidities and Coexisting Conditions, run by University of L'Aquila at 1 site in Italy.
Trial 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.). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Herpes Zoster, Comorbidities and Coexisting Conditions
- What is being tested?
- Hospitalization
- How many people
- 72,000 participants
- Where
- 1 siteItaly
- Study dates
- 26 Oct 2023to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of L'Aquila
L’Aquila, 67100
Antonella Mattei, PhD, antonella.mattei@univaq.it
Fabiana Fiasca, PhD
About this study
Official title: Nationwide Retrospective Observational Study of Herpes Zoster Associated Hospital Admissions in Italy
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.
Read the detailed description
Varicella (chickenpox) is a highly contagious illness sustained by an α Herpes virus called varicella-zoster virus (VZV). A replication phase in the penetration site is followed by a viremic phase when VZV spreads to skin and mucosae, leading to the typical rash and infection of sensory nerves in the epithelium, and then the reach of the sensory ganglia where it becomes latent. The reactivation of the latent virus, years or decades after primary infection, causes the typical clinical expression called Herpes Zoster (HZ) or shingles.
Post-herpetic neuralgia (PHN), an intractable pain in the dermatome affected by HZ, is the most common complication. It is estimated that it affects 10-20% of all patients with HZ aged ≥ 50 years and up to 30% of those aged ≥80 years. Management of PHN is not easy, but vaccination for prevention of PHN may be a strategic choice.
The most common complications of herpes zoster, other than PHN, often requiring hospitalization, include secondary bacterial infections, ophthalmic complications, cranial and peripheral nerve palsies, and segmental zoster paresis.
All authors agree that factors such as age, cell-mediated immunity (CMI) depression, intrauterine exposure to VZV and varicella occurring in early age (<18 months) are typically associated with HZ incidence. It further should be noted that age and CMI depression are strictly related since increasing age leads to CMI decrease. An increased incidence of hospitalization for HZ among patients aged >72 years (0.46/1000-person year), compared to those aged 15-44 years (0.03/1000-person year) was reported, suggesting that aging is also a risk factor for HZ requiring hospitalization. Besides age, HZ risk can be related to other co-morbidities, including diabetes, major depression or immunosuppressive therapies, that induce reduced VZV-specific CMI response. Immunosuppressed patients are within the high-risk group, with increasing morbidity and mortality associated with herpes zoster. Immunosuppression may be associated with malignancy (especially hematological), human immunodeficiency virus (HIV) infection or medications used for organ transplantation or autoimmune disease.
HZ incidence is similar all over the world and its trend is related to population age, with two thirds of the cases affecting subjects aged >50 years.
Among European adult population, the percentage of subjects estimated to be seropositive for anti-VZV antibodies is 95%: all of them are therefore potentially susceptible to develop HZ in their lifetime. In Italy, the annual incidence of HZ is 6.3/1000 person-years, with 73% of cases affecting adults.
Italy is one of the countries with the highest proportion of elderly people in its population, and yet data on the epidemiology of HZ and PHN are limited. As the immune system weakens with increasing age, many infectious diseases, such as HZ, are more severe and more closely associated with long-term consequences in the elderly than in younger people. With the growing aging population, a rise in the number of cases of HZ in the near future is expected; thus, this disease will become a public health issue. While awareness of childhood vaccination is well established, the prevention of infectious diseases in groups other than children is a challenging, yet fundamental, objective that public health systems should pursue in order to promote healthy aging.
In order to evaluate the epidemiological burden of HZ, hospital discharge records for HZ 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.
- Being tested
- Hospitalization
- Keywords
- Herpes Zoster, Vaccination, Hospitalizations, Comorbidities
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HospitalizationOther
Population of patients hospitalized for Herpes Zoster (ICD9-CM 053.xx)
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-morbidities among Herpes Zoster hospitalizations
Rate of patients hospitalized for Herpes Zoster with co-morbidities
Measured: 2011-2021
Secondary outcomes (4)
Shingles annual hospitalization rates
Shingles annual hospitalization rates in the Italian adult population aged 18+
Measured: 2011-2021
Shingles hospitalization rates by age classes
Shingles hospitalization rates by age classes:18-30; 31-40; 41-50; >50
Measured: 2011-2021
Herpes Zoster and COVID-19 infection
Proportion of patients with HZ vs. patients with HZ and COVID-19 infection
Measured: 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
Incidence Rate Ratio (IRR) of deaths, longer length of stay in hospital or presence of zoster-complications among Herpes Zoster-related hospitalizations in the entire Italian general adult population
Measured: 2011-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start26 Oct 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 72,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Antonella Mattei, University of L'Aquila
- Investigators
- Antonella Mattei, PhD, Principal investigator, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952271
- Sponsor's protocol ID
- 14112
- Status last verified
- Oct 2023
- First submitted
- 11 Jul 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25483522Grose 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.
PubMed 15911422Gabutti 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.
PubMed 19826547Koshy 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.
PubMed 29516900Gialloreti 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.
PubMed 20682044Stein 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.
PubMed 19027048Di 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.
PubMed 17889410Diez-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.
PubMed 25555381Pinchinat 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.
PubMed 23574765Nardone 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.
PubMed 17919788Calabro 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.
PubMed 32635467Valente 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.
PubMed 28608255Tartari 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.
PubMed 32530063Thomas 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.
PubMed 14720565Esteban-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.
PubMed 24805130
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nationwide Retrospective Observational Study of Herpes Zoster Associated Hospital Admissions in Italy
- ClinicalTrials.gov ID
- NCT05952271
- Acronym / sponsor ID
- 14112
- Keywords
- Herpes Zoster, Vaccination, Hospitalizations, Comorbidities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72,000 participants (estimated)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Varicella (chickenpox) is a highly contagious illness sustained by an α Herpes virus called varicella-zoster virus (VZV). A replication phase in the penetration site is followed by a viremic phase when VZV spreads to skin and mucosae, leading to the typical rash and infection of sensory nerves in the epithelium, and then the reach of the sensory ganglia where it becomes latent. The reactivation of the latent virus, years or decades after primary infection, causes the typical clinical expression called Herpes Zoster (HZ) or shingles.
Post-herpetic neuralgia (PHN), an intractable pain in the dermatome affected by HZ, is the most common complication. It is estimated that it affects 10-20% of all patients with HZ aged ≥ 50 years and up to 30% of those aged ≥80 years. Management of PHN is not easy, but vaccination for prevention of PHN may be a strategic choice.
The most common complications of herpes zoster, other than PHN, often requiring hospitalization, include secondary bacterial infections, ophthalmic complications, cranial and peripheral nerve palsies, and segmental zoster paresis.
All authors agree that factors such as age, cell-mediated immunity (CMI) depression, intrauterine exposure to VZV and varicella occurring in early age (<18 months) are typically associated with HZ incidence. It further should be noted that age and CMI depression are strictly related since increasing age leads to CMI decrease. An increased incidence of hospitalization for HZ among patients aged >72 years (0.46/1000-person year), compared to those aged 15-44 years (0.03/1000-person year) was reported, suggesting that aging is also a risk factor for HZ requiring hospitalization. Besides age, HZ risk can be related to other co-morbidities, including diabetes, major depression or immunosuppressive therapies, that induce reduced VZV-specific CMI response. Immunosuppressed patients are within the high-risk group, with increasing morbidity and mortality associated with herpes zoster. Immunosuppression may be associated with malignancy (especially hematological), human immunodeficiency virus (HIV) infection or medications used for organ transplantation or autoimmune disease.
HZ incidence is similar all over the world and its trend is related to population age, with two thirds of the cases affecting subjects aged >50 years.
Among European adult population, the percentage of subjects estimated to be seropositive for anti-VZV antibodies is 95%: all of them are therefore potentially susceptible to develop HZ in their lifetime. In Italy, the annual incidence of HZ is 6.3/1000 person-years, with 73% of cases affecting adults.
Italy is one of the countries with the highest proportion of elderly people in its population, and yet data on the epidemiology of HZ and PHN are limited. As the immune system weakens with increasing age, many infectious diseases, such as HZ, are more severe and more closely associated with long-term consequences in the elderly than in younger people. With the growing aging population, a rise in the number of cases of HZ in the near future is expected; thus, this disease will become a public health issue. While awareness of childhood vaccination is well established, the prevention of infectious diseases in groups other than children is a challenging, yet fundamental, objective that public health systems should pursue in order to promote healthy aging.
In order to evaluate the epidemiological burden of HZ, hospital discharge records for HZ 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HospitalizationPopulation of patients hospitalized for Herpes Zoster (ICD9-CM 053.xx) | Other | – |
Primary outcome
Co-morbidities among Herpes Zoster hospitalizations
Time frame: 2011-2021
Rate of patients hospitalized for Herpes Zoster with co-morbidities
4 secondary outcomes
Shingles annual hospitalization rates
Time frame: 2011-2021
Shingles hospitalization rates by age classes
Time frame: 2011-2021
Herpes Zoster and COVID-19 infection
Time frame: 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
Time frame: 2011-2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Background: PubMed 25483522Gabutti 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.
- Background: PubMed 15911422Grose 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.
- Background: PubMed 19826547Gabutti 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.
- Background: PubMed 29516900Koshy 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.
- Background: PubMed 20682044Gialloreti 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.
- Background: PubMed 19027048Stein 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.
- Background: PubMed 17889410Di 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.
- Background: PubMed 25555381Diez-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.
- Background: PubMed 23574765Pinchinat 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.
- Background: PubMed 17919788Nardone 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.
- Background: PubMed 32635467Calabro 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.
- Background: PubMed 28608255Valente 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonella Mattei, PhD principal investigator
University of L'Aquila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Herpes Zoster and Comorbidities and Coexisting Conditions, run by University of L'Aquila at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonella Mattei, PhD (+390862434651, antonella.mattei@univaq.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Co-morbidities among Herpes Zoster hospitalizations (time frame: 2011-2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05952271, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.