Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334861
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2023-03-13
Brief Title:
Multidisciplinary Hospital-Territory Vaccine Center a Model for Achieving the Herpes Zoster Vaccine Coverage
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Multidisciplinary Hospital-Territory Vaccine Center a Model for Achieving the Herpes Zoster Vaccine Coverage
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CeVOT-Her-Zo
Brief Summary:
The National Vaccination Program updated by the Ministry of Health in 2021 provides a new vaccination opportunity for frail patients against Herpes zoster virus HZ The new treatment option on the other hand is designed by combining VZV-specific antigen gE with an adjuvant system AS01B to induce antigen-specific cellular and humoral immune responses in individuals with preexisting immunity to VZV Efficacy assessed in people given two doses 2 months apart is around 97 in those aged 50 years and 91 in those over 70 years In the studies conducted HZ-related hospitalizations were significantly reduced The vaccine schedule calls for the administration of two doses 2 months apart The current HZ Vaccination Program implemented at the regional level recommends its active and free offer in people from 18 years of age with congenital andor acquired immunodepression through a collaborative relationship involving on the one hand multispecialist and multiprofessional medical staff and on the other hand citizens called to play a role that is no longer passive but the subject of empowerment by consciously making their own health choices The collaboration with ASL Roma1 in this sense acquires value as guarantor of the supply of the adjuvanted recombinant anti-HZ vaccine and of the appropriate reporting of vaccination coverage which to date is still far from the targets set by the PNPV17-19 in adults at risk for disease
The purpose of this study Single-center prospective longitudinal observational cohort study is to verify patients compliance with the proposed vaccination the effectiveness of counseling carried out by a multidisciplinary team in the hospital setting
The purpose of this study Single-center prospective longitudinal observational cohort study is to verify patients compliance with the proposed vaccination the effectiveness of counseling carried out by a multidisciplinary team in the hospital setting
Detailed Description:
Vaccinations are a safe and effective means of protecting populations against specific infectious diseases and are recommended at all ages The implementation of Vaccine Services also goes through the introduction of new modes of delivery with pathways increasingly suitable to promote and implement the prevention campaign The Hospital represents the place par excellence where categories of at-risk individuals are intercepted for whom adequate vaccine protection is a priority A Hospital Vaccine Center CVO therefore could effectively select patientsusers in both a programmed and an opportunity and initiative medicine perspective putting in place the national and regional indications that would like to integrate the vaccine offer with the clinical care pathways of at-risk categories that belong to different disciplines In line with these provisions of the Ministry of Health and the Lazio Region the CVO is also proposed as a referral structure for the immunization of patients with high clinical complexity in order to achieve optimization personalization and compliance with the vaccine program of individuals at higher risk who due to underlying diseases or ongoing treatments need monitoring of the antibody response and have an indication to be vaccinated in a protected environment
In concert with a forward-looking vision of Hospital as a Vaccine Care and Prevention Center the optimal vaccination pathway should be built in collaboration with the territorial reality becoming a strategic-cultural continuum of promoting vaccination both as individual protection of frail adults and as a solidaristic choice in the interest of the entire community So our project is proposed as an organizational synergy between the IRCCS Policlinico Universitario A Gemelli and ASL Roma 1 relying on the agreement stipulated between ASL Roma 1 and Policlinico Gemelli Foundation regarding the supply of vaccines thus ensuring cultural confrontation between hygienists and specialists involved in the care of frailty constituting a scientific training network of professionals dedicated to counseling and for the drafting of vaccine protocols dedicated to the various conditions of interest
The Strategic Advisory Group of Experts SAGE of the World Health Organization WHO defines vaccine hesitation as a delay in acceptance or refusal of vaccination despite vaccine availability In any case it appears mandated to put in place all interventions aimed at raising awareness of the benefits of vaccination counteracting misinformation fears and reticence The strategic value of the Hospital Vaccine Center model-pilot is inherent in offering the best and most appropriate immunological prophylaxis being able to seize the right time with respect to clinical-diagnostic and therapeutic-surgical follow-ups place and time most effective for both the user and the specialist managing patient care promoting technological and scientific innovativeness collecting and generating data immunogenicity efficacy safety compliance and integrated vaccine therapy-prevention operational protocols all in a real-world setting in specific fragile populations All this is done by leveraging the specialist-patient fiduciary relationship and facilitating the vaccine culture pathway that sees vaccine delivery integrated with patient care activities
The purpose of this study Single-center prospective longitudinal observational cohort study is to verify patients compliance with the proposed vaccination the effectiveness of counseling carried out by a multidisciplinary team in the hospital setting
Primary endpoint of the study is to verify patients compliance to the vaccination proposal in terms of the number of patients vaccinated compared to the total number of subjects eligible for vaccination and afferent to the participating OUs
Secondary endpoint
To assess the vaccination coverage of subjects afferent to the FPU Agostino Gemelli IRCCS
Assess vaccination coverage defined as the number of vaccinated patients compared to the total number of patients eligible for vaccination stratified by the different diseases from which the subjects are affected
Assessment of adverse reactions in terms of number type and time of onset since administration of the first and second dose both overall and stratified by baseline disease batch number of vaccine administered and dose
Assessment of Vaccine Confidence in the hospital setting in terms of results extracted from validation of the VAX scale both overall and stratified by the diseases they are affected by
Analysis of the economic impact of the anti-HZ vaccine pathway Patients with immunodeficiency andor immunosuppression afferent to the UOC Rheumatology UOC Hematology and Hematopoietic Stem Cell Transplantation UOC Infectious Diseases and Geriatric Internal Medicine Travel Clinic and Occupational Health Outpatient Clinic of the FPU Agostino Gemelli IRCCS who meet the inclusion criteria will be recruited
Inclusion Criteria
Patients with congenital andor acquired immunodepression
Age 18 years
Signature of informed consent
The study involves 4 phases
1 Implementation of an anti-HZ vaccine campaign from the date of approval of this study by the Local Ethics Committee at the Virtual CV afferent to the UOC Hospital Hygiene of the Agostino Gemelli IRCCS University Polyclinic Foundation
2 Vaccination slots will be sized according to requests from the Responsible Clinicians of individual DHs Vaccinations will be administered in an ad hoc identified room in each individual DH one dayweek from 8 am to 5 pm 4 vaccinationsh for a maximum of 40 vaccinationsday
3 Treating physicians will be responsible for listing selected patients for vaccination on the dedicated day The booster will be scheduled respecting the target eligible population deadline of 30 days between the first and second dose The vaccinating physicians assisted by a nurse proceed with the collection of the pre-vaccination history and the administration of informed consent Concurrently the administration of the Vaccination Attitudes Examination Scale VAX questionnaire an instrument validated in the literature for the study of vaccine hesitancy takes place Then the nurse administrators with the supervision of the nursing coordinator proceed with the administration of the vaccine After administration there is a waiting period of at least 15 minutes for surveillance of the occurrence of any adverse reactions for which appropriate medications and medical devices are provided
Suspected adverse reactions observed after vaccine administration will be reported to the Competent Authority AIFA in accordance with the provisions of the current regulations DM April 30 2015 according to the postmarketing pharmacovigilance flow httpswwwaifagovitcontentsegnalazioni-reazioni-avverse Medical and nursing staff at the vaccine site will report suspected adverse reactions that occurred during the scheduled observation period or if they become aware of them Vaccine recipients are required to report any adverse event suspected adverse reaction to the DH at which they received the vaccine and also to the treating physicians at the referring NICUs either through their GP or spontaneously by arranging for the report to be sent to AIFA through the dedicated online platform wwwvigifarmacoit or other planned modality httpswwwaifagovitcontentsegnalazioni-reazioni-avverse
4 Economic evaluation of the impact achieved by the vaccine campaign under study and data dissemination
Simile sizing Since this is a large-scale observational real-life study and given the purely exploratory primary endpoint formal sample sizing is not necessary However based on the data available from the referral departments for the past year it is estimated to include among the immunocompromised subjects covered by the recommendation to the anti-HZ vaccine campaign 50 HIV patients 50 onco-hematology subjects 50 immunocompromised rheumatology subjects 50 frail geriatric patients and 50 patients from the Travel Clinic and Occupational Health Outpatient Clinic for a total of 250 patients These numbers may be higher or lower depending on the supply of vaccine doses by ASL Roma 1
statistic analysis All variables under study will be assessed by descriptive statistical techniques In detail qualitative variables will be expressed as absolute frequencies and percentages Quantitative variables on the other hand after checking their distribution using the Shapiro Wilk test will be described as mean and standard deviation SD or median and interquartile range IQR Patients compliance with the proposed vaccination will be expressed in terms of the number and percentage of patients vaccinated out of the total number of subjects eligible for vaccination and afferent to the participating OUs in the project Potential associations between compliant and non-compliant subjects and the clinical and socio-demographic variables provided by the referring OUs will be assessed by means of the Chi-square test or Fishers exact test for qualitative data Quantitative data on the other hand will be assessed by Students t test or Mann Withneys U test depending on the distribution of the data Variables significantly associated with the univariable analysis will be included in a multivariable logistic regression model The same analyses will be conducted among the secondary endpoints by stratifying the population into subgroups according to their disease classes Adverse reactions to vaccines will be described in terms of absolute frequency and percentage of total doses administered and stratified by dose number first or second Their associations with underlying disease concomitant drugs time of onset from administration batch number and demographic variables will also be assessed using the statistical tests mentioned above The economic impact related to the introduction of the Herpes-Zoster vaccine campaign will be evaluated through a budget impact analysis BIA Specifically 2 alternative scenarios among them will be valued and their results will be expressed in the form of differential resources associated with the scenarios under analysis The perspective adopted is that of the institution ie Fondazione Policlinico Universitario Agostino Gemelli IRCCS Costs will be expressed in euros The time horizon of the analysis will be medium to short ie 1-5 years in accordance with international guidelines A cost-effectiveness evaluation will complement the BIA to simultaneously assess both costs and health outcomes associated with the presence of an anti-HZ vaccine pathway In this case both direct and indirect costs will be assessed The perspective to be taken in this analysis will be that of society Costs will be expressed in euros All analyses will be conducted with R software version 412 CRAN R Core 2021
In concert with a forward-looking vision of Hospital as a Vaccine Care and Prevention Center the optimal vaccination pathway should be built in collaboration with the territorial reality becoming a strategic-cultural continuum of promoting vaccination both as individual protection of frail adults and as a solidaristic choice in the interest of the entire community So our project is proposed as an organizational synergy between the IRCCS Policlinico Universitario A Gemelli and ASL Roma 1 relying on the agreement stipulated between ASL Roma 1 and Policlinico Gemelli Foundation regarding the supply of vaccines thus ensuring cultural confrontation between hygienists and specialists involved in the care of frailty constituting a scientific training network of professionals dedicated to counseling and for the drafting of vaccine protocols dedicated to the various conditions of interest
The Strategic Advisory Group of Experts SAGE of the World Health Organization WHO defines vaccine hesitation as a delay in acceptance or refusal of vaccination despite vaccine availability In any case it appears mandated to put in place all interventions aimed at raising awareness of the benefits of vaccination counteracting misinformation fears and reticence The strategic value of the Hospital Vaccine Center model-pilot is inherent in offering the best and most appropriate immunological prophylaxis being able to seize the right time with respect to clinical-diagnostic and therapeutic-surgical follow-ups place and time most effective for both the user and the specialist managing patient care promoting technological and scientific innovativeness collecting and generating data immunogenicity efficacy safety compliance and integrated vaccine therapy-prevention operational protocols all in a real-world setting in specific fragile populations All this is done by leveraging the specialist-patient fiduciary relationship and facilitating the vaccine culture pathway that sees vaccine delivery integrated with patient care activities
The purpose of this study Single-center prospective longitudinal observational cohort study is to verify patients compliance with the proposed vaccination the effectiveness of counseling carried out by a multidisciplinary team in the hospital setting
Primary endpoint of the study is to verify patients compliance to the vaccination proposal in terms of the number of patients vaccinated compared to the total number of subjects eligible for vaccination and afferent to the participating OUs
Secondary endpoint
To assess the vaccination coverage of subjects afferent to the FPU Agostino Gemelli IRCCS
Assess vaccination coverage defined as the number of vaccinated patients compared to the total number of patients eligible for vaccination stratified by the different diseases from which the subjects are affected
Assessment of adverse reactions in terms of number type and time of onset since administration of the first and second dose both overall and stratified by baseline disease batch number of vaccine administered and dose
Assessment of Vaccine Confidence in the hospital setting in terms of results extracted from validation of the VAX scale both overall and stratified by the diseases they are affected by
Analysis of the economic impact of the anti-HZ vaccine pathway Patients with immunodeficiency andor immunosuppression afferent to the UOC Rheumatology UOC Hematology and Hematopoietic Stem Cell Transplantation UOC Infectious Diseases and Geriatric Internal Medicine Travel Clinic and Occupational Health Outpatient Clinic of the FPU Agostino Gemelli IRCCS who meet the inclusion criteria will be recruited
Inclusion Criteria
Patients with congenital andor acquired immunodepression
Age 18 years
Signature of informed consent
The study involves 4 phases
1 Implementation of an anti-HZ vaccine campaign from the date of approval of this study by the Local Ethics Committee at the Virtual CV afferent to the UOC Hospital Hygiene of the Agostino Gemelli IRCCS University Polyclinic Foundation
2 Vaccination slots will be sized according to requests from the Responsible Clinicians of individual DHs Vaccinations will be administered in an ad hoc identified room in each individual DH one dayweek from 8 am to 5 pm 4 vaccinationsh for a maximum of 40 vaccinationsday
3 Treating physicians will be responsible for listing selected patients for vaccination on the dedicated day The booster will be scheduled respecting the target eligible population deadline of 30 days between the first and second dose The vaccinating physicians assisted by a nurse proceed with the collection of the pre-vaccination history and the administration of informed consent Concurrently the administration of the Vaccination Attitudes Examination Scale VAX questionnaire an instrument validated in the literature for the study of vaccine hesitancy takes place Then the nurse administrators with the supervision of the nursing coordinator proceed with the administration of the vaccine After administration there is a waiting period of at least 15 minutes for surveillance of the occurrence of any adverse reactions for which appropriate medications and medical devices are provided
Suspected adverse reactions observed after vaccine administration will be reported to the Competent Authority AIFA in accordance with the provisions of the current regulations DM April 30 2015 according to the postmarketing pharmacovigilance flow httpswwwaifagovitcontentsegnalazioni-reazioni-avverse Medical and nursing staff at the vaccine site will report suspected adverse reactions that occurred during the scheduled observation period or if they become aware of them Vaccine recipients are required to report any adverse event suspected adverse reaction to the DH at which they received the vaccine and also to the treating physicians at the referring NICUs either through their GP or spontaneously by arranging for the report to be sent to AIFA through the dedicated online platform wwwvigifarmacoit or other planned modality httpswwwaifagovitcontentsegnalazioni-reazioni-avverse
4 Economic evaluation of the impact achieved by the vaccine campaign under study and data dissemination
Simile sizing Since this is a large-scale observational real-life study and given the purely exploratory primary endpoint formal sample sizing is not necessary However based on the data available from the referral departments for the past year it is estimated to include among the immunocompromised subjects covered by the recommendation to the anti-HZ vaccine campaign 50 HIV patients 50 onco-hematology subjects 50 immunocompromised rheumatology subjects 50 frail geriatric patients and 50 patients from the Travel Clinic and Occupational Health Outpatient Clinic for a total of 250 patients These numbers may be higher or lower depending on the supply of vaccine doses by ASL Roma 1
statistic analysis All variables under study will be assessed by descriptive statistical techniques In detail qualitative variables will be expressed as absolute frequencies and percentages Quantitative variables on the other hand after checking their distribution using the Shapiro Wilk test will be described as mean and standard deviation SD or median and interquartile range IQR Patients compliance with the proposed vaccination will be expressed in terms of the number and percentage of patients vaccinated out of the total number of subjects eligible for vaccination and afferent to the participating OUs in the project Potential associations between compliant and non-compliant subjects and the clinical and socio-demographic variables provided by the referring OUs will be assessed by means of the Chi-square test or Fishers exact test for qualitative data Quantitative data on the other hand will be assessed by Students t test or Mann Withneys U test depending on the distribution of the data Variables significantly associated with the univariable analysis will be included in a multivariable logistic regression model The same analyses will be conducted among the secondary endpoints by stratifying the population into subgroups according to their disease classes Adverse reactions to vaccines will be described in terms of absolute frequency and percentage of total doses administered and stratified by dose number first or second Their associations with underlying disease concomitant drugs time of onset from administration batch number and demographic variables will also be assessed using the statistical tests mentioned above The economic impact related to the introduction of the Herpes-Zoster vaccine campaign will be evaluated through a budget impact analysis BIA Specifically 2 alternative scenarios among them will be valued and their results will be expressed in the form of differential resources associated with the scenarios under analysis The perspective adopted is that of the institution ie Fondazione Policlinico Universitario Agostino Gemelli IRCCS Costs will be expressed in euros The time horizon of the analysis will be medium to short ie 1-5 years in accordance with international guidelines A cost-effectiveness evaluation will complement the BIA to simultaneously assess both costs and health outcomes associated with the presence of an anti-HZ vaccine pathway In this case both direct and indirect costs will be assessed The perspective to be taken in this analysis will be that of society Costs will be expressed in euros All analyses will be conducted with R software version 412 CRAN R Core 2021
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None