Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06334861 |
| Other study ID # |
5001 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 23, 2022 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
March 2023 |
| Source |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Contact |
Patrizia Laurenti, MD Phd |
| Phone |
(+39) 06 30155701 |
| Email |
patrizia.laurenti[@]policlinicogemelli.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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 and/or 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 PNPV'17-'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.
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 patients/users 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
I.R.C.C.S. 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 and/or immunosuppression afferent to the U.O.C. Rheumatology, U.O.C.
Hematology and Hematopoietic Stem Cell Transplantation, U.O.C. 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 and/or 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 U.O.C. 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 day/week from 8 am to 5 pm (4 vaccinations/h for a maximum of 40
vaccinations/day).
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
(https://www.aifa.gov.it/content/segnalazioni-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 (www.vigifarmaco.it) or other planned modality
(https://www.aifa.gov.it/content/segnalazioni-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 Fisher's exact test for qualitative data. Quantitative data, on the
other hand, will be assessed by Student's t test or Mann Withney's 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 (i.e., Fondazione Policlinico
Universitario Agostino Gemelli IRCCS). Costs will be expressed in euros (€). The time horizon
of the analysis will be medium to short (i.e., 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 4.1.2 (CRAN ®, R Core 2021).
