带状疱疹复发、重组带状疱疹疫苗在≥50岁有带状疱疹病史的成年人中的安全性和免疫原性：一项3期随机对照试验

IF 11.9 1区医学 Q1 INFECTIOUS DISEASES

Journal of Infection Pub Date : 2025-08-06 DOI:10.1016/j.jinf.2025.106573

Bisi Jegede , Yingjun Zhou , Helen Hawksworth , David S.C. Hui , Nathali Montenegro Guerra , Airi Põder , Josep M. Ramon , Hanna Välimaa , Guadalupe Delfina Villanueva-Quintero , Agnes Mwakingwe-Omari , on behalf of the Z-062 study group

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引用次数: 0

摘要

目的：评估重组带状疱疹疫苗（RZV）在既往患有HZ的成年人中的HZ复发（主要目标）、安全性和免疫原性。方法：这项3期、观察者盲、多国研究（NCT04091451）招募了年龄≥50岁、6个月前有一次HZ发作缓解的参与者，以1:1的比例随机分配，间隔2个月接受两剂RZV或安慰剂。采用水痘-带状疱疹病毒聚合酶链反应（pcr）和HZ判定法对复发性HZ病例进行诊断。如果RZV组与安慰剂组HZ复发率比（IRR）的95%置信区间（CI）上限为，则满足≥26个月HZ复发的非劣效性目标。结果：在1426名接受RZV(714)/安慰剂(712)≥1剂量的参与者中，确认有8例HZ复发病例，均为安慰剂组(IRR RVZ vs安慰剂：0.00 [95%CI: 0.00-0.46]；非自卑目标达到)。没有发现任何安全信号。两剂RZV在该人群中引起了强大的免疫反应。结论：在既往患有HZ≥50年的参与者中，RZV不会增加HZ复发的风险。RZV具有免疫原性，安全性结果与疫苗已知的安全性一致，为支持在该人群中使用RZV提供了证据。

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Herpes zoster recurrence, and safety and immunogenicity of the recombinant zoster vaccine in adults aged ≥50 years with a history of herpes zoster: A phase 3, randomized controlled trial

Objectives

To assess HZ recurrence (primary objective), safety and immunogenicity of the recombinant zoster vaccine (RZV) in adults with prior HZ.

Methods

This phase 3, observer-blind, multi-country study (NCT04091451) enrolled participants ≥50 years with one resolved HZ episode >6 months prior, randomized 1:1 to receive two RZV or placebo doses 2 months apart. Recurrent HZ cases were confirmed by an algorithm comprising varicella-zoster virus-PCR and HZ adjudication determination. The non-inferiority objective for HZ recurrence over ≥26 months was met if the upper limit of the 95% confidence interval (CI) of the HZ recurrence incidence rate ratio (IRR) in the RZV vs placebo groups was <5. Reactogenicity, broad safety, humoral and cell-mediated immunogenicity were also evaluated.

Results

Among 1426 participants receiving ≥1 dose of RZV (714)/placebo (712), eight HZ recurrence cases were confirmed, all in placebo recipients (IRR RVZ vs placebo: 0.00 [95%CI: 0.00–0.46]; non-inferiority objective met). No safety signals were identified. Two RZV doses elicited robust immune responses in this population.

Conclusion

In participants ≥50 years with prior HZ, RZV does not increase HZ recurrence risk. RZV was immunogenic, and safety results were consistent with the vaccine’s known safety profile, providing evidence to support RZV use in this population.

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来源期刊

Journal of Infection 医学-传染病学

CiteScore

45.90

自引率

3.20%

发文量

475

审稿时长

16 days

期刊介绍： The Journal of Infection publishes original papers on all aspects of infection - clinical, microbiological and epidemiological. The Journal seeks to bring together knowledge from all specialties involved in infection research and clinical practice, and present the best work in the ever-changing field of infection. Each issue brings you Editorials that describe current or controversial topics of interest, high quality Reviews to keep you in touch with the latest developments in specific fields of interest, an Epidemiology section reporting studies in the hospital and the general community, and a lively correspondence section.