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NCT06334861: CeVOT-Her-Zo
Multidisciplinary Hospital-Territory Vaccine Center: a Model for Achieving the Herpes Zoster Vaccine Coverage
trial testing Herpes Zoster adjuvanted recombinant vaccine in Herpes Zoster in 178 participants. Completed in 30 July 2024.
15 May 2024
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 178 |
| Start date | 23 June 2022 |
| Primary completion | 15 May 2024 |
| Estimated completion | 30 July 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Herpes Zoster adjuvanted recombinant vaccine — full drug profile →
Conditions studied
- Herpes Zoster — all drugs for Herpes Zoster →
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
18 and older, any sex, with Herpes Zoster. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Understanding Attitudes Toward Zoster Vaccination in the Hospital Setting: A Multidisciplinary Model to Contrast Vaccine Hesitancy in Fragile Patients-A Prospective Longitudinal Observational Study.
Regazzi L, Martinelli S, Rizzo F, Tamburrini E, et al · · 2025 · PMID 40872928 · DOI 10.3390/vaccines13080843 -
Understanding Attitudes Toward Zoster Vaccination in the Hospital Setting: A Multidisciplinary Model to Contrast Vaccine Hesitancy in Fragile Patients. A prospective longitudinal observational study
Martinelli S, Regazzi L, Rizzo F, Tamburrini E, et al · · 2024 · DOI 10.21203/rs.3.rs-5474948/v1
Verify or expand the search:
- PubMed search for NCT06334861
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Herpes Zoster
Currently open trials in the same condition.
- NCT07400003 — Study to Evaluate the Safety and Immunogenicity of a Lyophilized Herpes Zoster Virus mRNA Vaccine · Phase 1, PHASE2 · recruiting
- NCT07307170 — The Analgesic Efficacy and Safety of Mirogabalin in Patients With Herpes Zoster · NA · recruiting
- NCT07293065 — A Phase III Clinical Trial to Evaluate Long-Term Protective Efficacy of Recombinant Zoster Vaccine (CHO Cell) · Phase 3 · active not recruiting
- NCT07361796 — The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes · NA · recruiting
- NCT07378046 — The Analgesic Efficacy and Safety of Baclofen in Patients With Herpes Zoster · NA · recruiting
Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials
Trials by the same sponsor.
- NCT07514572 — Impact of Estimated Weight and Height on Nutritional Assessment in Elderly · NA · not yet recruiting
- NCT07504679 — Adipose Visceral and Epicardial Risk Evaluation · NA · not yet recruiting
- NCT07520643 — MISTIC Study: Atherosclerosis, Neurocognition & Cardiovascular Signaling · not yet recruiting
- NCT07479238 — Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy · not yet recruiting
- NCT07494227 — Development of the SC-IBD Self-Care Measurement Scale · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06334861 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Last refreshed: 27 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06334861.
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