Prospective Cohort-study for the Investigation of the Vac-cine-induced Immune Response After Vaccination Against RESPiratory Viral Infections in Immunocompromised Pa-tients With or Without Haemato-ONcological diseaSEs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Humoral immune response after vaccination
研究概览
简要总结
Managing respiratory virus infections in immunocompromised patients requires a multidisciplinary approach, including vaccination, though its effectiveness is often suboptimal in these individuals.
In hematological patients, poor humoral immunogenicity is common, especially when the B cell axis is affected by disease or treatment, while T cell responses may offer better protection. Current immunologic data on these patients is limited, focusing mostly on serologic parameters. To address this, we will conduct an observational study analyzing early and late booster vaccinations, with a focus on virus-specific T cell responses in vaccinated patients.
详细描述
Respiratory virus infections are a significant cause of morbidity and mortality, partic-ularly among immunocompromised patients. These infections are caused by a varie-ty of viral pathogens, including influenza viruses, respiratory syncytial virus (RSV), parainfluenza viruses, adenoviruses, rhinoviruses, and coronaviruses, among oth-ers. In the general population, these infections typically result in self-limiting ill-nesses; however, in individuals with compromised immune systems, such as those undergoing chemotherapy, organ transplant recipients, patients with haematological malignancies, and those with HIV, the consequences can be severe and often life-threatening. For example, patients with haematological and oncological diseases are at elevated risk for severe morbidity and mortality by influenza infections. Com-pared to influenza-associated hospitalization rates in the general population (37.9 per 100,000 person-years for persons age 50 to 64 years)1 patients with cancer were hospitalized at a rate of 219 per 100,000 person-years for patients younger than 65 years.
The immune system plays a crucial role in defending against viral pathogens. Im-munocompromised patients, due to either primary immune deficiencies or second-ary immunosuppression (e.g., from immunosuppressive therapies), have impaired immune responses that hinder the effective clearance of viral infections. This im-pairment can lead to prolonged viral shedding, increased risk of secondary bacterial infections, and more severe disease manifestations, including acute respiratory dis-tress syndrome (ARDS) and multi-organ failure. The management of respiratory vi-rus infections in immunocompromised patients requires a multidisciplinary ap-proach. Prophylactic measures, including vaccination and the use of antiviral prophylaxis, are crucial in reducing the incidence of these infections.
Given the significant impact of respiratory virus infections on immunocompromised patients, ongoing research is crucial to improve preventive strategies. This research includes studies on viral pathophysiology, host immune responses, and the devel-opment of optimal vaccination schedules. The emergence of new viral pathogens, such as SARS-CoV-2, underscores the importance of surveillance and prepared-ness in this vulnerable population.
Respiratory virus infections represent a major health concern for immunocompro-mised patients, necessitating comprehensive and specialised care. Continued ad-vancements in diagnostics, therapeutics, and preventive measures are vital to miti-gate the impact of these infections and improve the quality of life and survival of immunocompromised individuals.
The management of respiratory virus infections in immunocompromised patients requires a multidisciplinary approach and prophylactic measures, including vaccina-tion, to reduce the incidence and severity of these infections. However, the efficacy of vaccination is often suboptimal in immunocompromised individuals and not well assessed in clinical trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent form
- •Patients with immunosuppression either by treatment or underlying diseases
- •Patients who are vaccinated or willing to be vaccinated against respiratory virus infections in ac-cordance with current recommendations
- •Age of 18 years or older
排除标准
- •Patients unwilling/ineligible for vaccination under current recommendations
结局指标
主要结局
Humoral immune response after vaccination
时间窗: 12 months
To compare antibody titres between different subgroups of immunocompromised patients after vaccination against respiratory virus infections
次要结局
- Cellular immune response after vaccination(12 months)
- Seroconversion(12 months)
研究者
Sibylle C Mellinghoff
Board certified medical doctor
University of Cologne
