二价呼吸道合胞病毒 preF 疫苗与季节性流感灭活疫苗在老年人中联合使用的安全性和免疫原性。

Safety and Immunogenicity of Bivalent RSVpreF Vaccine Coadministered With Seasonal Inactivated Influenza Vaccine in Older Adults.

机构信息

Barwon Health, Deakin University, Geelong, Victoria, Australia.

Vaccine Clinical Research, Pfizer Australia Pty Ltd, Sydney, New South Wales, Australia.

出版信息

Clin Infect Dis. 2024 May 15;78(5):1360-1368. doi: 10.1093/cid/ciad707.

BACKGROUND

Respiratory syncytial virus (RSV) and influenza are both typically seasonal diseases, with winter peaks in temperate climates. Coadministration of an RSV vaccine and influenza vaccine could be a benefit, requiring 1 rather than 2 visits to a healthcare provider for individuals receiving both vaccines.

METHODS

The primary immunogenicity objective of this phase 3, 1:1 randomized, double-blind, placebo-controlled study in healthy adults aged ≥65 years in Australia was to demonstrate noninferiority of immune responses with coadministration of the stabilized RSV prefusion F protein-based vaccine (RSVpreF) and seasonal inactivated influenza vaccine (SIIV) versus SIIV or RSVpreF administered alone, using a 1.5-fold noninferiority margin (lower bound 95% confidence interval >.667). Safety and tolerability were evaluated by collecting reactogenicity and adverse event data.

RESULTS

Of 1403 participants randomized, 1399 received vaccinations (median age, 70; range, 65‒91 years). Local reactions and systemic events were mostly mild or moderate when RSVpreF was coadministered with SIIV or administered alone. No vaccine-related serious adverse events were reported. Geometric mean ratios were 0.86 for RSV-A and 0.85 for RSV-B neutralizing titers at 1 month after RSVpreF administration and 0.77 to 0.90 for strain-specific hemagglutination inhibition assay titers at 1 month after SIIV. All comparisons achieved the prespecified 1.5-fold noninferiority margin.

CONCLUSIONS

The primary study objectives were met, demonstrating noninferiority of RSVpreF and SIIV immune responses when RSVpreF was coadministered with SIIV and that RSVpreF had an acceptable safety and tolerability profile when coadministered with SIIV. The results of this study support coadministration of RSVpreF and SIIV in an older-adult population.

CLINICAL TRIALS REGISTRATION

https://clinicaltrials.gov/study/NCT05301322.

背景

呼吸道合胞病毒（RSV）和流感都是典型的季节性疾病，在温带气候中冬季达到高峰。RSV 疫苗和流感疫苗联合接种可能会带来益处，因为对于同时接种两种疫苗的个体来说，只需 1 次就诊即可完成接种，而不是 2 次。

方法

本研究是一项在澳大利亚≥65 岁健康成年人中开展的、以 1:1 随机、双盲、安慰剂对照设计进行的 3 期研究，主要免疫原性目标是证明 RSV 融合前 F 蛋白基稳定疫苗（RSVpreF）和季节性灭活流感疫苗（SIIV）联合接种与 SIIV 或 RSVpreF 单药接种相比，免疫应答具有非劣效性，使用 1.5 倍非劣效性边界（下限 95%置信区间>0.667）。通过收集不良反应和不良事件数据评估安全性和耐受性。

结果

1403 名随机分组的参与者中，1399 名（中位年龄 70 岁；范围 65 岁至 91 岁）接受了疫苗接种。当 RSVpreF 与 SIIV 联合使用或单独使用时，局部反应和全身事件主要为轻度或中度。未报告与疫苗相关的严重不良事件。RSVpreF 给药后 1 个月时，针对 RSV-A 和 RSV-B 的中和滴度的几何均数比值分别为 0.86 和 0.85，针对 SIIV 的血凝抑制试验滴度的比值为 0.77 至 0.90。所有比较均达到了预设的 1.5 倍非劣效性边界。