NVX-CoV2373（TAK-019）疫苗在健康日本成年人中的安全性和免疫原性：一项 I/II 期随机对照试验的中期报告。
Safety and immunogenicity of NVX-CoV2373 (TAK-019) vaccine in healthy Japanese adults: Interim report of a phase I/II randomized controlled trial.
机构信息
Japan Development, Global Vaccine Business Unit, Takeda Pharmaceutical Company Ltd, Japan.
Japan Medical and Policy Affairs, Medical Affairs Office, Global Vaccine Business Unit, Takeda Pharmaceutical Company Ltd, Japan.
出版信息
Vaccine. 2022 May 26;40(24):3380-3388. doi: 10.1016/j.vaccine.2022.04.035. Epub 2022 Apr 29.
BACKGROUND
We evaluated the safety and immunogenicity of NVX-CoV2373, a recombinant SARS-CoV-2 nanoparticle vaccine, in healthy Japanese participants.
METHODS
This phase 1/2, randomized, observer-blind, placebo-controlled trial conducted in Japan (two sites), enrolled healthy Japanese adults aged ≥ 20 years with no history/risk of SARS-CoV-2 infection and no prior exposure to other approved/investigational SARS-CoV-2 vaccines or treatments. Participants were stratified by age (< 65 or ≥ 65 years) and randomized to receive two doses of either NVX-CoV2373 (5 μg SARS-CoV-2 rS; 50 μg Matrix-M1) or placebo, 21 days apart. Primary outcomes were safety and immunogenicity assessed by serum IgG antibody levels against SARS-CoV-2 rS protein on day 36. Herein, we report the primary data analysis at 4 weeks after the second dose, ahead of 12-month follow-up completion (data cut-off: 8 May 2021).
RESULTS
Between 12 February 2021 and 17 March 2021, 326 subjects were screened, and 200 participants enrolled and randomized: NVX-CoV2373, n = 150; placebo, n = 50. Solicited adverse events (AEs) through 7 days after each injection occurred in 121/150 (80.7%) and 11/50 (22.0%) participants in the NVX-CoV2373 and placebo arms, respectively. In the NVX-CoV2373 arm, tenderness and injection site pain were the most frequently reported solicited AEs after each vaccination, irrespective of age. Robust immune responses occurred with NVX-CoV2373 (n = 150) by day 36: IgG geometric mean fold rise (95% confidence interval) 259 (219, 306); seroconversion rate 100% (97.6, 100). No such response occurred with placebo (n = 49).
CONCLUSION
Two doses of NVX-CoV2373 given with a 21-day interval demonstrated acceptable safety and induced robust anti-SARS-CoV-2 immune responses in healthy Japanese adults.
FUNDING
Takeda Pharmaceutical Company Limited and Japan Agency for Medical Research and Development (AMED).
CLINICALTRIALS
gov identifier: NCT04712110.
背景
我们评估了 NVX-CoV2373（一种重组 SARS-CoV-2 纳米颗粒疫苗）在健康日本参与者中的安全性和免疫原性。
方法
这项在日本（两个地点）进行的 1/2 期、随机、观察者盲法、安慰剂对照试验纳入了无 SARS-CoV-2 感染史/风险且无其他已批准/正在研究的 SARS-CoV-2 疫苗或治疗药物既往暴露史的健康日本成年人，年龄≥20 岁。参与者按年龄（<65 岁或≥65 岁）分层，并随机接受两剂 NVX-CoV2373（5μg SARS-CoV-2 rS；50μg Matrix-M1）或安慰剂，间隔 21 天。主要结局是通过血清 IgG 抗体水平评估 SARS-CoV-2 rS 蛋白在第 36 天的安全性和免疫原性。在此，我们报告了第二次给药后 4 周的主要数据分析，早于 12 个月随访完成（数据截止日期：2021 年 5 月 8 日）。
结果
在 2021 年 2 月 12 日至 3 月 17 日期间，筛选了 326 名受试者，200 名受试者入组并随机分组：NVX-CoV2373 组，n=150；安慰剂组，n=50。NVX-CoV2373 组和安慰剂组分别有 121/150（80.7%）和 11/50（22.0%）的受试者在每次注射后 7 天内出现了不良事件（AE）。在 NVX-CoV2373 组中，无论年龄大小，每次接种后，压痛和注射部位疼痛是最常报告的不良事件。NVX-CoV2373（n=150）在第 36 天产生了强烈的免疫应答：IgG 几何平均倍数升高（95%置信区间）259（219，306）；血清转化率 100%（97.6，100）。安慰剂组（n=49）未出现这种反应。
结论
间隔 21 天给予两剂 NVX-CoV2373 具有可接受的安全性，并在健康日本成年人中诱导了强烈的抗 SARS-CoV-2 免疫应答。
资金
武田制药有限公司和日本医疗研究与发展机构（AMED）。
临床试验
gov 标识符：NCT04712110。
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