Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F (RSVPreF3) Candidate Vaccine in Older Adults: Phase 1/2 Randomized Clinical Trial.
Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F (RSVPreF3) Candidate Vaccine in Older Adults: Phase 1/2 Randomized Clinical Trial.
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呼吸道合胞病毒预融合 F (RSVPreF3) 候选疫苗在老年人中的安全性和免疫原性：1/2 期随机临床试验。
DOI：
10.1093/infdis/jiac327
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发表时间：
2023-03-28
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影响因子：
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本研究旨在研究呼吸道合胞病毒(RSV)融合蛋白稳定预融合构象(RSVPreF3)疫苗制剂的安全性和免疫原性。这项1/2阶段的随机对照观察者盲法研究在2019年1月至8月期间招募了48名年轻人(YAS；年龄18-40岁)和1005名老年人(OAS；年龄60-80岁)。参与者被随机分成相同大小的组，分别接受2剂非佐剂(YAS和OAS)或AS01佐剂(OAS)疫苗或安慰剂，间隔2个月。第二次免疫后1个月(YAS)或12个月(OAS)评估疫苗的安全性和免疫原性。RSVPreF3疫苗可增强体液免疫应答(RSVPreF3特异性免疫球蛋白G[IgG]和RSV-A中和抗体)，且呈抗原浓度依赖性增加，且在接种1次后最高。与接种前相比，免疫后多功能CD4+T细胞几何平均频率增加，且佐剂组显著高于未接种组。接种后的免疫反应一直持续到随访结束。征集到的不良反应大多是轻微到中度和短暂的。尽管观察到含有AS01的疫苗具有较高的反应性，但没有发现任何评估配方的安全问题。根据安全性和免疫原性，选择了含120μg rSVPreF3的AS01E佐剂疫苗用于进一步的临床开发。NCT03814590。含有呼吸道合胞病毒融合蛋白稳定预融合构象(RSVPreF3)的呼吸道合胞病毒疫苗制剂具有良好的耐受性和免疫原性。根据安全性和免疫原性特征，选择了含120μg重组病毒前F3的AS01E佐剂疫苗用于进一步的临床研究。
The aim of this study was to investigate safety and immunogenicity of vaccine formulations against respiratory syncytial virus (RSV) containing the stabilized prefusion conformation of RSV fusion protein (RSVPreF3). This phase 1/2, randomized controlled, observer-blind study enrolled 48 young adults (YAs; aged 18–40 years) and 1005 older adults (OAs; aged 60–80 years) between January and August 2019. Participants were randomized into equally sized groups to receive 2 doses of unadjuvanted (YAs and OAs) or AS01-adjuvanted (OAs) vaccine or placebo 2 months apart. Vaccine safety and immunogenicity were assessed until 1 month (YAs) or 12 months (OAs) after second vaccination. The RSVPreF3 vaccines boosted humoral (RSVPreF3-specific immunoglobulin G [IgG] and RSV-A neutralizing antibody) responses, which increased in an antigen concentration-dependent manner and were highest after dose 1. Compared to prevaccination, the geometric mean frequencies of polyfunctional CD4+ T cells increased after each dose and were significantly higher in adjuvanted than unadjuvanted vaccinees. Postvaccination immune responses persisted until end of follow-up. Solicited adverse events were mostly mild to moderate and transient. Despite a higher observed reactogenicity of AS01-containing vaccines, no safety concerns were identified for any assessed formulation. Based on safety and immunogenicity profiles, the AS01E-adjuvanted vaccine containing 120 μg of RSVPreF3 was selected for further clinical development. NCT03814590. Vaccine formulations against respiratory syncytial virus (RSV) containing the stabilized prefusion conformation of RSV fusion protein (RSVPreF3) were well tolerated and immunogenic. Based on safety/immunogenicity profiles, the AS01E-adjuvanted vaccine containing 120 μg of RSVPreF3 was selected for further clinical development.
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影响因子：
3.7
作者：
Hause AM;Henke DM;Avadhanula V;Shaw CA;Tapia LI;Piedra PA
通讯作者：
Piedra PA
影响因子：
7.8
作者：
Stephens LM;Varga SM
通讯作者：
Varga SM
DOI：
10.1093/infdis/jit839
发表时间：
2014-06-15
期刊：
The Journal of infectious diseases
影响因子：
--
作者：
Falsey AR;McElhaney JE;Beran J;van Essen GA;Duval X;Esen M;Galtier F;Gervais P;Hwang SJ;Kremsner P;Launay O;Leroux-Roels G;McNeil SA;Nowakowski A;Richardus JH;Ruiz-Palacios G;St Rose S;Devaster JM;Oostvogels L;Durviaux S;Taylor S
通讯作者：
Taylor S
影响因子：
8.6
作者：
Leroux-Roels, Geert;Marchant, Arnaud;Van Mechelen, Marcelle
通讯作者：
Van Mechelen, Marcelle
影响因子：
4.8
作者：
Schwarz, Tino F.;Volpe, Stephanie;Bastidas, Adriana
通讯作者：
Bastidas, Adriana