Abstract：
BACKGROUND: The adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine (RSVPreF3 OA) is approved in adults aged ≥60 years. We evaluated RSVPreF3 OA immunogenicity and safety in adults aged 50-59 years without or with increased risk for RSV disease due to specific chronic medical conditions.
METHODS: This observer-blind, phase 3, noninferiority trial included adults aged 50-59 years, stratified into 2 subcohorts: those with and those without predefined, stable, chronic medical conditions leading to an increased risk for RSV disease. Participants in both subcohorts were randomized 2:1 to receive RSVPreF3 OA or placebo. A control group of adults aged ≥60 years received RSVPreF3 OA. Primary outcomes were RSV-A and RSV-B neutralization titers (geometric mean titer ratios and sero-response rate differences) 1 month post-vaccination in 50-59-year-olds versus ≥60-year-olds. Cell-mediated immunity and safety were also assessed.
RESULTS: The exposed population included 1152 participants aged 50-59 years and 381 participants aged ≥60 years. RSVPreF3 OA was immunologically noninferior in 50-59-year-olds versus ≥60-year-olds; noninferiority criteria were met for RSV-A and RSV-B neutralization titers in those with and those without increased risk for RSV disease. Frequencies of RSVPreF3-specific polyfunctional CD4+ T cells increased substantially from pre- to 1 month post-vaccination. Most solicited adverse events had mild-to-moderate intensity and were transient. Unsolicited and serious adverse event rates were similar in all groups.
CONCLUSIONS: RSVPreF3 OA was immunologically noninferior in 50-59-year-olds compared to ≥60-year-olds, in whom efficacy was previously demonstrated. The safety profile in 50-59-year-olds was consistent with that in ≥60-year-olds.
BACKGROUND: ClinicalTrials.gov: NCT05590403.
METHODS: This observer-blind, phase 3, noninferiority trial included adults aged 50-59 years, stratified into 2 subcohorts: those with and those without predefined, stable, chronic medical conditions leading to an increased risk for RSV disease. Participants in both subcohorts were randomized 2:1 to receive RSVPreF3 OA or placebo. A control group of adults aged ≥60 years received RSVPreF3 OA. Primary outcomes were RSV-A and RSV-B neutralization titers (geometric mean titer ratios and sero-response rate differences) 1 month post-vaccination in 50-59-year-olds versus ≥60-year-olds. Cell-mediated immunity and safety were also assessed.
RESULTS: The exposed population included 1152 participants aged 50-59 years and 381 participants aged ≥60 years. RSVPreF3 OA was immunologically noninferior in 50-59-year-olds versus ≥60-year-olds; noninferiority criteria were met for RSV-A and RSV-B neutralization titers in those with and those without increased risk for RSV disease. Frequencies of RSVPreF3-specific polyfunctional CD4+ T cells increased substantially from pre- to 1 month post-vaccination. Most solicited adverse events had mild-to-moderate intensity and were transient. Unsolicited and serious adverse event rates were similar in all groups.
CONCLUSIONS: RSVPreF3 OA was immunologically noninferior in 50-59-year-olds compared to ≥60-year-olds, in whom efficacy was previously demonstrated. The safety profile in 50-59-year-olds was consistent with that in ≥60-year-olds.
BACKGROUND: ClinicalTrials.gov: NCT05590403.
摘要：
背景：基于佐剂的呼吸道合胞病毒（RSV）融合前F蛋白的疫苗（RSVPreF3OA）已在≥60岁的成年人中获得批准。我们评估了年龄在50-59岁的成年人中的RSVPreF3OA免疫原性和安全性，这些成年人没有或由于特定的慢性病而增加了RSV疾病的风险。
方法：这种观察者盲，第三阶段，非劣效性试验包括50-59岁的成年人，分为2个子队列：有和没有预定义的，稳定,导致RSV疾病风险增加的慢性医疗条件。两个亚组的参与者以2：1随机分配接受RSVPreF3OA或安慰剂。对照组年龄≥60岁的成年人接受RSVPreF3。主要结果是在50-59岁与≥60岁的人群中，接种后1个月的RSV-A和RSV-B中和滴度（几何平均滴度比和血清反应率差异）。还评估了细胞介导的免疫和安全性。
结果：暴露人群包括1152名50-59岁的参与者和381名年龄≥60岁的参与者。与≥60岁的人相比，50-59岁的人的RSVPreF3OA在免疫学上不差；在有和没有增加RSV疾病风险的人中，RSV-A和RSV-B中和滴度均符合非劣效性标准。RSVPreF3特异性多功能CD4+T细胞的频率从接种前到接种后1个月显著增加。大多数征求的不良事件具有轻度至中度的强度，并且是短暂的。所有组的主动和严重不良事件发生率相似。
结论：RSVPreF3OA在50-59岁人群中与≥60岁人群相比在免疫学上不差，以前证明过的疗效。50-59岁人群的安全性与≥60岁人群的安全性一致。
背景：ClinicalTrials.gov：NCT05590403。
方法：这种观察者盲，第三阶段，非劣效性试验包括50-59岁的成年人，分为2个子队列：有和没有预定义的，稳定,导致RSV疾病风险增加的慢性医疗条件。两个亚组的参与者以2：1随机分配接受RSVPreF3OA或安慰剂。对照组年龄≥60岁的成年人接受RSVPreF3。主要结果是在50-59岁与≥60岁的人群中，接种后1个月的RSV-A和RSV-B中和滴度（几何平均滴度比和血清反应率差异）。还评估了细胞介导的免疫和安全性。
结果：暴露人群包括1152名50-59岁的参与者和381名年龄≥60岁的参与者。与≥60岁的人相比，50-59岁的人的RSVPreF3OA在免疫学上不差；在有和没有增加RSV疾病风险的人中，RSV-A和RSV-B中和滴度均符合非劣效性标准。RSVPreF3特异性多功能CD4+T细胞的频率从接种前到接种后1个月显著增加。大多数征求的不良事件具有轻度至中度的强度，并且是短暂的。所有组的主动和严重不良事件发生率相似。
结论：RSVPreF3OA在50-59岁人群中与≥60岁人群相比在免疫学上不差，以前证明过的疗效。50-59岁人群的安全性与≥60岁人群的安全性一致。
背景：ClinicalTrials.gov：NCT05590403。
