Introduction: Recombinant Zoster Vaccine (RZV) is recommended for Herpes Zoster (HZ) prevention inhigh-risk patients over 18 years of age.Research design and methods: This is a prospective population-based study conducted over a three-year period in a Southern Italian General Hospital. The study population was represented by RZVrecipients with diverse chronic comorbidities. Adverse Events Following Immunization (AEFIs), baselinedisease flares and post-vaccination HZ episodes were evaluated through sequential follow-ups con-ducted 7 days, 3 months, and 3–38 months post-vaccination, respectively.Results: Study population included 787 RZV recipients, mostly affected by onco-hematological, cardi-ovascular and rheumatological disorders. The AEFIs reporting rate was 44.15%. The most frequentsymptoms were injection site pain/itching (37.19%), asthenia/malaise (12.74%) and fever (10.30%).Three serious AEFIs with consistent causal association with vaccination were recorded (0.22%), all ofwhich underwent full recovery. Sixteen patients (2.37%) experienced a baseline condition flare-upwithin 3 months (mean interval 33.88 ± 24.88 days). Multiple baseline disorders (OR:1.97; 95%CI:1.37–2.83; p-value < 0.001) and rheumatological conditions (OR:11.67; 95%CI:2.00–68.27; p-value <0.01) increased flare risk, while male sex decreased it. Twenty-six vaccinees manifested HZ post-vaccination (cumulative incidence rate 5.05/100,000 person-days), with particularly increased incidencein patients with recurrent/severe HZ history (IRR:14.35; 95%CI:5.64–34.04; p-value < 0.001).Conclusion: The study demonstrates RZV safety and HZ protection in vulnerable patients, consistentlywith available evidence.
Safety profile and medium- to long-term protection of the Recombinant Zoster Vaccine (RZV) in a cohort of high-risk patients: real-world data from a General Hospital in Southern Italy, 2021-2025
Pasquale Stefanizzi;Lorenza Moscara;Claudia Palmieri;Andrea Martinelli;Antonio Di Lorenzo;Chiara Scaltrito;Petra Buonvino;Francesca Oliveto;Giovanna Pice;Laura Marchisella;Giuseppe Spinelli;Silvio Tafuri
2025-01-01
Abstract
Introduction: Recombinant Zoster Vaccine (RZV) is recommended for Herpes Zoster (HZ) prevention inhigh-risk patients over 18 years of age.Research design and methods: This is a prospective population-based study conducted over a three-year period in a Southern Italian General Hospital. The study population was represented by RZVrecipients with diverse chronic comorbidities. Adverse Events Following Immunization (AEFIs), baselinedisease flares and post-vaccination HZ episodes were evaluated through sequential follow-ups con-ducted 7 days, 3 months, and 3–38 months post-vaccination, respectively.Results: Study population included 787 RZV recipients, mostly affected by onco-hematological, cardi-ovascular and rheumatological disorders. The AEFIs reporting rate was 44.15%. The most frequentsymptoms were injection site pain/itching (37.19%), asthenia/malaise (12.74%) and fever (10.30%).Three serious AEFIs with consistent causal association with vaccination were recorded (0.22%), all ofwhich underwent full recovery. Sixteen patients (2.37%) experienced a baseline condition flare-upwithin 3 months (mean interval 33.88 ± 24.88 days). Multiple baseline disorders (OR:1.97; 95%CI:1.37–2.83; p-value < 0.001) and rheumatological conditions (OR:11.67; 95%CI:2.00–68.27; p-value <0.01) increased flare risk, while male sex decreased it. Twenty-six vaccinees manifested HZ post-vaccination (cumulative incidence rate 5.05/100,000 person-days), with particularly increased incidencein patients with recurrent/severe HZ history (IRR:14.35; 95%CI:5.64–34.04; p-value < 0.001).Conclusion: The study demonstrates RZV safety and HZ protection in vulnerable patients, consistentlywith available evidence.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
