Safety and immunogenicity of an mRNA-based RSV vaccine in Japanese older adults aged ≥60 years: A phase 1, randomized, observer-blind, placebo-controlled trial

IF 2.4 Q2 RESPIRATORY SYSTEM
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Abstract

Background

Respiratory syncytial virus (RSV) represents a global health concern, including in older adults. This study assessed the safety and immunogenicity of mRNA-1345, an investigational mRNA RSV vaccine, in adults aged ≥60 years of Japanese descent.

Methods

In this phase 1, randomized, observer-blind, placebo-controlled study, participants were randomized to receive one injection of mRNA-1345 100 μg or placebo. Solicited local and systemic adverse reactions (ARs) were collected within 7 days following injection. Unsolicited adverse events (AEs) were collected up to 28 days after injection; AEs of special interest, medically attended AEs, and serious AEs were collected through end of study. Immunogenicity was assessed at baseline and months 1, 2, 3, and 6 following injection.

Results

Twenty-five adults of Japanese descent aged ≥60 years received one injection of mRNA-1345 100 μg (n = 21) or placebo (n = 4). mRNA-1345 was well-tolerated; the most common local and systemic solicited ARs were injection site pain, and fatigue and myalgia, respectively, which were generally mild to moderate and transient. No serious AEs were reported. Neutralizing (nAb) and binding (bAb) antibodies were detectable at baseline, consistent with prior RSV exposure. mRNA-1345 boosted RSV nAb titers and preF bAb concentrations 1 month post-injection (geometric mean fold rise: RSV-A nAb, 11.2; RSV-B nAb, 6.6; preF bAb, 9.1). Titers among mRNA-1345 recipients remained above baseline through 6 months.

Conclusions

mRNA-1345 100 μg was well-tolerated among older adults of Japanese descent and induced nAbs and bAbs which were durable through 6 months, supporting its continued development.

Trial registration

ClinicalTrials.gov, NCT04528719.

基于 mRNA 的 RSV 疫苗在年龄≥60 岁的日本老年人中的安全性和免疫原性:1期随机、观察盲、安慰剂对照试验
背景呼吸道合胞病毒(RSV)是全球关注的健康问题,包括老年人。这项研究评估了 mRNA-1345 的安全性和免疫原性,mRNA-1345 是一种研究性 mRNA RSV 疫苗,适用于年龄≥60 岁的日裔成人。方法在这项 1 期随机、观察盲、安慰剂对照研究中,参与者被随机分配接受一次 mRNA-1345 100 μg 或安慰剂注射。研究人员在注射后 7 天内收集了患者的局部和全身不良反应(ARs)。在注射后 28 天内收集主动提出的不良反应 (AE);在研究结束前收集特别关注的不良反应、医疗护理不良反应和严重不良反应。结果25名年龄≥60岁的日裔成人接受了一次 mRNA-1345 100 μg(n = 21)或安慰剂(n = 4)注射。mRNA-1345的耐受性良好;最常见的局部和全身性征求不良反应分别是注射部位疼痛、疲劳和肌痛,一般为轻度至中度和一过性。无严重不良反应报告。注射后 1 个月,mRNA-1345 可提高 RSV nAb 滴度和 preF bAb 浓度(几何平均折叠上升:RSV-A nAb,11.2;RSV-B nAb,6.6;preF bAb,9.1)。结论 mRNA-1345 100 μg 在日裔老年人中耐受性良好,诱导的 nAb 和 bAb 可持续 6 个月,支持继续开发。
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来源期刊
Respiratory investigation
Respiratory investigation RESPIRATORY SYSTEM-
CiteScore
4.90
自引率
6.50%
发文量
114
审稿时长
64 days
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