Cremer Louise Marie, Bethe Ullrich, Borchmann Peter, Di Cristanziano Veronica, Gieselmann Lutz, Grimm Sarah, Hellmich Martin, Jakobs Julia, Nacov Julia A, Neuhann Julia M, Prattes Juergen, Scheid Christoph, Sprute Rosanne, Steger Gertrud, Stemler Jannik, Mellinghoff Sibylle C, Cornely Oliver A
Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.
Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.
JMIR Res Protoc. 2025 May 26;14:e60675. doi: 10.2196/60675.
Despite the availability of vaccines, immunocompromised patients are still at high risk for severe COVID-19. Vaccination has been proven to be an effective measure in preventing severe SARS-CoV-2 infections; however, data on B- and T-cell responses are lacking. While vaccination schedules for the general population have been defined, achieving immunogenicity in patients who are immunocompromised remains a challenge.
The primary objective is to analyze anti-spike-immunoglobulin G (IgG) titers after repeated messenger ribonucleic acid vaccinations in patients who are immunocompromised. Further objectives are to analyze data on humoral immune responses and to evaluate data on cellular immune responses.
This multicenter, prospective, noninterventional study aims to determine the immunogenicity and reactogenicity of an implemented standard-of-care COVID-19 vaccination strategy in patients who are immunocompromised. A total of 100 patients will be recruited at three study sites. Patients are eligible for study inclusion when they are 18 years or older, vaccinated according to the recent version of the COVID-19 vaccination standard, and if the patient is immunocompromised according to stage 3 of the classification "Stages of Immunosuppression." The study analyzes B- and T-cell responses generated within the standard-of-care COVID-19 vaccination strategy. Additional blood samples will be drawn at each scheduled outpatient visit. Study-related blood samples will be used to extract ethylenediaminetetraacetic acid plasma and peripheral blood mononuclear cells for evaluation of B- and T-cell responses to COVID-19 vaccinations. For this study, no additional visits or invasive procedures will be performed in addition to standard care.
As of August 2024, the study has enrolled 32 patients. The recruitment phase is still ongoing.
Results will be used to optimize vaccination and booster schedules for patients who are immunocompromised and to increase rates of protection against severe SARS-CoV-2 infections. Further, results may identify risk and treatment factors, which lead to low immune responses in patients vaccinated against COVID-19, as well as the impact of repeated vaccination on B- and T-cell responses.
ClinicalTrials.gov NCT05597761; https://clinicaltrials.gov/study/NCT05597761.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/60675.
尽管有疫苗可用，但免疫功能低下的患者仍面临严重 COVID-19 的高风险。疫苗接种已被证明是预防严重 SARS-CoV-2 感染的有效措施；然而，关于 B 细胞和 T 细胞反应的数据尚缺。虽然已确定了普通人群的疫苗接种计划，但在免疫功能低下的患者中实现免疫原性仍然是一项挑战。
主要目的是分析免疫功能低下患者在重复接种信使核糖核酸疫苗后的抗刺突免疫球蛋白 G（IgG）滴度。进一步的目的是分析体液免疫反应数据并评估细胞免疫反应数据。
这项多中心、前瞻性、非干预性研究旨在确定在免疫功能低下患者中实施的标准护理 COVID-19 疫苗接种策略的免疫原性和反应原性。将在三个研究地点招募总共 100 名患者。当患者年龄在 18 岁及以上、根据最新版 COVID-19 疫苗接种标准进行接种、且根据“免疫抑制阶段”分类的第 3 阶段属于免疫功能低下时， eligible for study inclusion。该研究分析标准护理 COVID-19 疫苗接种策略中产生的 B 细胞和 T 细胞反应。在每次预定的门诊就诊时将采集额外的血样。与研究相关的血样将用于提取乙二胺四乙酸血浆和外周血单核细胞，以评估对 COVID-19 疫苗接种的 B 细胞和 T 细胞反应。对于本研究，除标准护理外，不会进行额外的就诊或侵入性操作。
截至 2024 年 8 月，该研究已招募 32 名患者。招募阶段仍在进行中。
研究结果将用于优化免疫功能低下患者的疫苗接种和加强接种计划，并提高预防严重 SARS-CoV-2 感染的保护率。此外，结果可能会确定导致 COVID-19 疫苗接种患者免疫反应低下的风险和治疗因素，以及重复接种对 B 细胞和 T 细胞反应的影响。
ClinicalTrials.gov NCT05597761；https://clinicaltrials.gov/study/NCT05597761。
国际注册报告标识符（IRRID）：DERR1-10.2196/60675。
