P-112. Characterization of Herpes Zoster Cases and Sustained High Vaccine Efficacy Against Herpes Zoster Complications in Individuals Vaccinated with Recombinant Zoster Vaccine During A Long-Term Follow-Up Study
Authors: Leon Rafael , Curran Desmond , Strezova Ana , Díez-Domingo Javier , Matthews Sean , Tsang Manyee , Shi Meng , Mwakingwe-Omar Agnes 
Published: January 2025

Background

ZOE-LTFU was an extension of two pivotal efficacy trials (ZOE-50/70) following participants vaccinated with adjuvanted recombinant zoster vaccine (RZV). Vaccine efficacy (VE) against herpes zoster (HZ) from 1 month post dose 2 up to 11 years was 87.7%. Here, we report characteristics of confirmed HZ cases during ZOE-LTFU, focusing on pain and complications.

Methods

ZOE-LTFU was a phase 3b, open-label study conducted in 18 countries between 2016 and 2023 (NCT02723773). Participants from the original randomized trials (NCT01165177 and NCT01165229) who received ≥1 dose of RZV were eligible. Pain experienced during an HZ episode was evaluated by the Zoster Brief Pain Inventory (ZBPI) until 90 days after first HZ visit or a 4-week pain-free period was achieved.

Results

Of 7273 participants included in the primary cohort for VE analysis, 69 experienced a confirmed HZ episode and 61 had a first ZBPI evaluation within 16 days of rash start. Median age at first vaccination was 71.0 (50.0–87.0) years (N=69). Most participants (58/61, 95.1%) reported pain, while 52 (85.2%) and 38 (62.3%) reported clinically significant pain (score ≥ 3) and severe pain (score ≥ 7), respectively (Fig. 1). Mean Worst Pain Score was 6.7 (standard deviation 3.0). Clinically significant pain resolved after a median of 19 days; Kaplan-Meier analysis is shown in Fig. 2. Most participants (85.2%) received pain medication with a trend for longer duration of use with increasing age (Table 1). VE was 87.5% (95% confidence interval [CI] 64.8, 96.8) against post-herpetic neuralgia (PHN) and 91.7% (95% CI 43.7, 99.8) against non-PHN complications in participants ≥ 50 years; complications occurred in participants ≥ 76 years 6–10 years after vaccination (Table 2).

Conclusion

The limited numbers of HZ cases in ZOE-LTFU were associated with less frequent HZ complications. Cases and complications were more common with older age. VE against PHN and non-PHN complications was sustained over 11 years of follow-up and comparable to the original studies. Overall, these findings support the long-term clinical benefit of RZV in prevention of HZ and its complications.

FUNDING: GSK

Disclosures

Rafael Leon, GSK: Employee|GSK: Stocks/Bonds (Private Company) Desmond Curran, PhD, GSK: employee|GSK: Stocks/Bonds (Public Company) Ana Strezova, MD, MSc, GSK: Employee|GSK: Stocks/Bonds (Private Company) Javier Díez-Domingo, MD, PhD, GSK: Advisor/Consultant|GSK: Grant/Research Support|GSK: Honoraria|Moderna: Advisor/Consultant|Moderna: Grant/Research Support|Moderna: Honoraria|MSD: Advisor/Consultant|MSD: Grant/Research Support|MSD: Honoraria|Pfizer: Advisor/Consultant|Pfizer: Honoraria|SANOFI: Advisor/Consultant|SANOFI: Grant/Research Support|SANOFI: Honoraria Sean Matthews, MSc, GSK: Advisor/Consultant Manyee Tsang, n/a, GSK: Employee|GSK: Stocks/Bonds (Public Company) Meng Shi, MS, GSK: Employee Agnes Mwakingwe-Omar, MD, PhD, GSK: Employed|GSK: Stocks/Bonds (Private Company)