A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Single Vaccination of Ad26.RSV.preF-Based Regimen in Japanese Adults Aged 60 Years and Older

IF 4.3 4区医学 Q1 INFECTIOUS DISEASES Influenza and Other Respiratory Viruses Pub Date : 2024-06-16 DOI:10.1111/irv.13336

Takashi Eto, Yusuke Okubo, Atsushi Momose, Hiroshi Tamura, Richuan Zheng, Benoit Callendret, Arangassery Rosemary Bastian, Christy A. Comeaux

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Abstract

Background

Respiratory syncytial virus (RSV) is increasingly recognized as a significant cause of lower respiratory tract disease (LRTD) in older adults. The Ad26.RSV.preF/RSV preF protein vaccine demonstrated protective efficacy against RSV related LRTD in a Phase 2b study in the United States. Hence, Ad26.RSV.preF/RSV preF protein vaccine candidate was evaluated in the Japanese older adult population.

Methods

This Phase 1 study evaluated safety, reactogenicity, and immunogenicity of Ad26.RSV.preF/RSV preF protein vaccine at dose level of 1 × 10¹¹ vp/150 μg in Japanese healthy adult aged ≥60 years. The study included a screening Phase, vaccination, 28-day follow up Phase, a 182-day follow-up period, and final visit on Day 183. A total of 36 participants were randomized in a 2:1 ratio to receive Ad26.RSV.preF/RSV preF protein vaccine (n = 24) or placebo (n = 12). After study intervention administration, the safety and immunogenicity analysis were performed as per planned schedule. Immune responses including virus-neutralizing and preF-specific binding antibodies were measured on Days 1, 15, 29, and 183.

Results

There were no deaths, SAEs, or AEs leading to discontinuation reported during the study. The Ad26.RSV.preF/RSV preF protein vaccine had acceptable safety and tolerability profile with no safety concern in Japanese older adults. The Ad26.RSV.preF/RSV preF protein vaccine induced RSV-specific humoral immunity, with increase in antibody titers on Days 15 and 29 compared with baseline which was well maintained until Day 183.

Conclusions

A single dose of Ad26.RSV.preF/RSV preF protein vaccine had an acceptable safety and tolerability profile and induced RSV-specific humoral immunity in Japanese healthy adults.

Trial Registration

NCT number: NCT04354480; Clinical Registry number: CR108768.

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一项随机、双盲、安慰剂对照的 1 期研究，旨在评估基于 Ad26.RSV.preF 方案的单次疫苗接种对 60 岁及以上日本成人的安全性、致反应性和免疫原性。

背景：呼吸道合胞病毒（RSV）越来越被认为是导致老年人下呼吸道疾病（LRTD）的重要原因。在美国进行的一项 2b 期研究中，Ad26.RSV.preF/RSV preF 蛋白疫苗证明了对 RSV 相关 LRTD 的保护效力。因此，Ad26.RSV.preF/RSV preF 蛋白候选疫苗在日本老年人群中进行了评估：这项 1 期研究评估了 Ad26.RSV.preF/RSV preF 蛋白疫苗的安全性、反应原性和免疫原性，疫苗剂量为 1 × 1011 vp/150 μg，接种对象为年龄≥60 岁的日本健康成年人。该研究包括筛选阶段、接种阶段、28 天的随访阶段、182 天的随访期以及第 183 天的最终访问。共有 36 名参与者按 2:1 的比例随机接种 Ad26.RSV.preF/RSV preF 蛋白疫苗（n = 24）或安慰剂（n = 12）。研究干预给药后，按计划进行安全性和免疫原性分析。在第 1、15、29 和 183 天测量免疫反应，包括病毒中和抗体和前 F 特异性结合抗体：结果：研究期间没有死亡、SAE 或导致停药的 AE 报告。Ad26.RSV.preF/RSV preF蛋白疫苗在日本老年人中具有可接受的安全性和耐受性，没有安全问题。Ad26.RSV.preF/RSV preF蛋白疫苗可诱导RSV特异性体液免疫，第15天和第29天的抗体滴度与基线相比有所上升，并一直维持到第183天：单剂量 Ad26.RSV.preF/RSV preF 蛋白疫苗具有可接受的安全性和耐受性，可诱导日本健康成年人产生 RSV 特异性体液免疫：NCT 编号：NCT04354480试验注册：NCT04354480；临床注册编号：CR108768：CR108768。

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来源期刊

Influenza and Other Respiratory Viruses 医学-病毒学

CiteScore

7.20

自引率

4.50%

发文量

120

审稿时长

6-12 weeks

期刊介绍： Influenza and Other Respiratory Viruses is the official journal of the International Society of Influenza and Other Respiratory Virus Diseases - an independent scientific professional society - dedicated to promoting the prevention, detection, treatment, and control of influenza and other respiratory virus diseases. Influenza and Other Respiratory Viruses is an Open Access journal. Copyright on any research article published by Influenza and Other Respiratory Viruses is retained by the author(s). Authors grant Wiley a license to publish the article and identify itself as the original publisher. Authors also grant any third party the right to use the article freely as long as its integrity is maintained and its original authors, citation details and publisher are identified.