PDF(Pubmed)
Abstract：
This study assessed three Ad26.RSV.preF/RSV preF protein combinations, combining different Ad26.RSV.preF doses and naturally aged preF protein, representing the expected critical vaccine quality attributes close to release, around intermediate shelf-life (ISL) and near-presumed end-of-shelf-life (EoSL), as a way to evaluate the vaccine immunogenicity and safety throughout its shelf-life. A single dose of Ad26.RSV.preF/RSV preF protein vaccine was administered to adults 60-75 years of age. Solicited adverse events (AEs), unsolicited AEs, and serious AEs (SAEs) were assessed for 7-day, 28-day, and 6-month periods after vaccination, respectively. RSV preF-binding antibody concentrations and RSV neutralizing titers were measured 14 days post-vaccination as primary and secondary endpoints, respectively; binding antibodies were also measured 6 months post-vaccination. The RSV preF-binding antibody responses induced by Ad26.RSV.preF/RSV preF protein vaccine lots representing the critical quality attributes around ISL and near presumed EoSL were noninferior to the responses induced by the vaccine lot representing the critical quality attributes near release. The RSV preF-binding and RSV neutralizing antibody levels measured 14 days post-vaccination were similar across the 3 groups. RSV preF-binding antibody concentrations were also similar 6 months post-vaccination. Solicited AEs were mostly mild to moderate in intensity, and a decreased reactogenicity was observed from the Release group to the ISL and EoSL group. None of the reported SAEs were considered related to study vaccination. The study provided evidence of sustained immunogenicity and safety over the intended shelf-life of the Ad26.RSV.pref/RSV preF protein vaccine. The three vaccine lots had acceptable safety profiles.
摘要：
这项研究评估了三个Ad26。RSV.preF/RSVpreF蛋白组合，结合不同的Ad26。RSV.preF剂量和自然老化的preF蛋白，代表接近发布的预期关键疫苗质量属性，在中间保质期(ISL)和近乎推定的保质期结束(EoSL)附近，作为评估疫苗在整个保质期内的免疫原性和安全性的一种方法。单剂量的Ad26。RSV.对60~75岁的成人使用preF/RSVpreF蛋白疫苗.引起的不良事件（AE），未经请求的AE，和严重的AE（SAE）进行了7天的评估，28天,接种疫苗后6个月，分别。接种后14天测量RSV前F结合抗体浓度和RSV中和滴度作为主要和次要终点，分别;接种后6个月还测量了结合抗体。由Ad26诱导的RSV前F结合抗体应答。RSV.代表ISL和接近假定EoSL的关键质量属性的preF/RSVpreF蛋白疫苗批次不劣于代表接近释放的关键质量属性的疫苗批次诱导的反应。接种后14天测量的RSV前F结合和RSV中和抗体水平在3组中相似。接种后6个月RSV前F结合抗体浓度也相似。诱发的AE强度大多为轻度至中度，从释放组到ISL和EoSL组观察到反应原性降低。没有报告的SAE被认为与研究疫苗接种有关。该研究提供了在Ad26的预期保质期内的持续免疫原性和安全性的证据。RSV.pref/RSVpreF蛋白疫苗。三个疫苗批次具有可接受的安全性。
