一项在已接种 SARS-CoV-2 疫苗的≥75 岁成年人中评估不同 COVID-19 疫苗免疫原性和反应原性的多国、2 期、随机、自适应方案：在 VACCELERATE 网络内开展的一项试验。
A multinational, phase 2, randomised, adaptive protocol to evaluate immunogenicity and reactogenicity of different COVID-19 vaccines in adults ≥75 already vaccinated against SARS-CoV-2 (EU-COVAT-1-AGED): a trial conducted within the VACCELERATE network.
机构信息
Faculty of Medicine and University Hospital Cologne, Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Herderstr. 52, 50931, Cologne, Germany.
Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.
出版信息
Trials. 2022 Oct 8;23(1):865. doi: 10.1186/s13063-022-06791-y.
BACKGROUND
In the ongoing COVID-19 pandemic, advanced age is a risk factor for a severe clinical course of SARS-CoV-2 infection. Thus, older people may benefit in particular from booster doses with potent vaccines and research should focus on optimal vaccination schedules. In addition to each individual's medical history, immunosenescence warrants further research in this population. This study investigates vaccine-induced immune response over 1 year.
METHODS/DESIGN: EU-COVAT-1-AGED is a randomised controlled, adaptive, multicentre phase II protocol evaluating different booster strategies in individuals aged ≥75 years (n=600) already vaccinated against SARS-CoV-2. The initial protocol foresaw a 3rd vaccination (1st booster) as study intervention. The present modified Part B of this trial foresees testing of mRNA-1273 (Spikevax®) vs. BNT162b2 (Comirnaty®) as 4th vaccination dose (2nd booster) for comparative assessment of their immunogenicity and safety against SARS-CoV-2 wild-type and variants. The primary endpoint of the trial is to assess the rate of 2-fold antibody titre increase 14 days after vaccination measured by quantitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wild-type virus. Secondary endpoints include the changes in neutralising antibody titres (Virus Neutralisation Assay) against wild-type as well as against Variants of Concern (VOC) at 14 days and up to 12 months. T cell response measured by qPCR will be performed in subgroups at 14 days as exploratory endpoint. Biobanking samples are being collected for neutralising antibody titres against potential future VOC. Furthermore, potential correlates between humoral immune response, T cell response and neutralising capacity will be assessed. The primary endpoint analysis will be triggered as soon as for all patients the primary endpoint (14 days after the 4th vaccination dose) has been observed.
DISCUSSION
The EU-COVAT-1-AGED trial Part B compares immunogenicity and safety of mRNA-1273 (Spikevax®) and BNT162b2 (Comirnaty®) as 4th SARS-CoV-2 vaccine dose in adults ≥75 years of age. The findings of this trial have the potential to optimise the COVID-19 vaccination strategy for this at-risk population.
TRIAL REGISTRATION
ClinicalTrials.gov NCT05160766 . Registered on 16 December 2021.
PROTOCOL VERSION
V06_0: 27 July 2022.
背景
在持续的 COVID-19 大流行中，高龄是 SARS-CoV-2 感染严重临床病程的一个危险因素。因此，老年人可能特别受益于强效疫苗的加强针，研究应侧重于最佳的疫苗接种时间表。除了每个人的病史外，免疫衰老也需要在该人群中进一步研究。本研究调查了 1 年内的疫苗诱导免疫反应。
方法/设计：EU-COVAT-1-AGED 是一项随机对照、适应性、多中心的 II 期方案，评估了≥75 岁的个体（n=600）中不同加强针策略，这些个体已接种 SARS-CoV-2 疫苗。初始方案预计将第三次接种（第 1 次加强针）作为研究干预措施。本试验的现行修改后的第 B 部分预计将测试 mRNA-1273（Spikevax®）与 BNT162b2（Comirnaty®）作为第 4 次接种剂量（第 2 次加强针），以比较评估它们对野生型 SARS-CoV-2 及其变体的免疫原性和安全性。该试验的主要终点是评估接种后 14 天通过定量酶联免疫吸附试验（Anti-RBD-ELISA）测量的针对野生型病毒的 2 倍抗体滴度增加率。次要终点包括接种后 14 天和 12 个月时针对野生型和关注变异株（VOC）的中和抗体滴度（病毒中和试验）的变化。T 细胞反应将在 14 天作为探索性终点在亚组中进行测量。正在采集生物样本库样本，以测量针对潜在未来 VOC 的中和抗体滴度。此外，还将评估体液免疫反应、T 细胞反应和中和能力之间的潜在相关性。一旦所有患者（第 4 次接种后 14 天）观察到主要终点，将立即触发主要终点分析。
讨论
EU-COVAT-1-AGED 试验第 B 部分比较了 mRNA-1273（Spikevax®）和 BNT162b2（Comirnaty®）作为≥75 岁成年人的第 4 次 SARS-CoV-2 疫苗剂量的免疫原性和安全性。本试验的结果有可能优化高危人群的 COVID-19 疫苗接种策略。
试验注册
ClinicalTrials.gov NCT05160766。注册于 2021 年 12 月 16 日。
方案版本
V06_0：2022 年 7 月 27 日。
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