背景:最近批准的基于AS01E佐剂的呼吸道合胞病毒(RSV)融合前F蛋白的老年人疫苗(RSVPreF3OA)在≥60岁的人群中表现出对RSV相关疾病的高疗效。
方法:这项在≥60岁人群中进行的3期研究评估了RSVPreF3OA疫苗接种后3年的免疫持久性。这里,我们描述了体液和细胞介导的免疫原性的中期结果,反应原性,和安全性,直到1年剂量后1。
结果:总计,1653名参与者接种了疫苗。剂量1后一个月,中和滴度相对于剂量1前增加10.5倍(RSV-A)和7.8倍(RSV-B)。然后,滴度在第6个月下降到比剂量1前高4.4倍(RSV-A)和3.5倍(RSV-B)的水平,并保持3.1倍(RSV-A)和2.3倍(RSV-B)高于1年后的剂量1水平。RSVPreF3结合免疫球蛋白G水平和CD4+T细胞频率显示相似的动力学。62.2%和49.5%的参与者报告了可疑的给药部位和全身不良事件(主要是轻度至中度和短暂)。3.9%的参与者在剂量1后6个月内报告了严重不良事件;1例被认为与疫苗相关。
结论:一种RSVPreF3OA剂量引起细胞介导的和RSV-A-和RSV-B-特异性体液免疫反应,随着时间的推移而下降,但保持在剂量1前水平以上至少1年。该疫苗具有良好的耐受性,具有可接受的安全性。临床试验注册。NCT04732871(ClinicalTrials.gov)。
呼吸道合胞病毒(RSV)是老年人患病和住院的主要原因。GSK开发的老年人RSV疫苗最近获得批准。该疫苗具有良好的耐受性,并在至少1个RSV季节期间在≥60岁的成年人中提供针对RSV疾病的保护。在这项正在进行的研究中,我们正在评估免疫反应的强度和持久性,以及疫苗的安全性,5个国家/地区≥60岁的成年人接种疫苗后3年。这里,我们报告了1剂疫苗接种后1年的中期分析结果.总的来说,1653名参与者接种了疫苗。我们发现疫苗诱导了强烈的免疫反应,这在接种疫苗1个月后很明显,之后下降,但持续了至少1年。研究参与者最常报告注射部位疼痛,肌肉疼痛,疲倦,和头痛作为不良反应,大多为轻度至中度,持续时间短。一个严重的不良反应被认为与疫苗有关。在该研究中观察到的长期免疫应答与在至少1个RSV季节期间提供保护的疫苗一致。
BACKGROUND: The recently approved AS01E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine for older adults (RSVPreF3 OA) demonstrated high efficacy against RSV-related disease in ≥60-year-olds.
METHODS: This ongoing phase 3 study in ≥60-year-olds evaluates immune persistence until 3 years after RSVPreF3 OA vaccination. Here, we describe interim results on humoral and cell-mediated immunogenicity, reactogenicity, and safety until 1 year post-dose 1.
RESULTS: In total, 1653 participants were vaccinated. One month post-dose 1, neutralization titers increased 10.5-fold (RSV-A) and 7.8-fold (RSV-B) vs pre-dose 1. Titers then declined to levels 4.4-fold (RSV-A) and 3.5-fold (RSV-B) above pre-dose 1 at month 6 and remained 3.1-fold (RSV-A) and 2.3-fold (RSV-B) above pre-dose 1 levels after 1 year. RSVPreF3-binding immunoglobulin G levels and CD4+ T-cell frequencies showed similar kinetics. Solicited administration-site and systemic adverse events (mostly mild to moderate and transient) were reported by 62.2% and 49.5% of participants. Serious adverse events were reported by 3.9% of participants within 6 months post-dose 1; 1 case was considered vaccine related.
CONCLUSIONS: One RSVPreF3 OA dose elicited cell-mediated and RSV-A- and RSV-B-specific humoral immune responses that declined over time but remained above pre-dose 1 levels for at least 1 year. The vaccine was well tolerated with an acceptable safety profile. Clinical Trials Registration. NCT04732871 (ClinicalTrials.gov).
Respiratory syncytial virus (RSV) is a major cause of illness and hospitalization in older adults. An RSV vaccine for older adults developed by GSK was recently approved. The vaccine was well tolerated and provided protection against RSV disease in adults aged ≥60 years during at least 1 RSV season. In this ongoing study, we are evaluating the magnitude and durability of the immune response, as well as vaccine safety, until 3 years after vaccination of adults aged ≥60 years from 5 countries. Here, we report the results of an interim analysis until 1 year after vaccination with 1 dose. In total, 1653 participants were vaccinated. We found that the vaccine induced a strong immune response that was evident 1 month after vaccination, after which it declined but persisted for at least 1 year. Study participants most often reported pain at the injection site, muscle pain, tiredness, and headache as adverse reactions, which were mostly mild to moderate and of short duration. One serious adverse reaction was considered related to the vaccine. The long-term immune response that was observed in this study is consistent with the vaccine providing protection during at least 1 RSV season.