Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612515
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Vaccine-induced Immunity in Immunocompromised Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESPONSE
Brief Summary:
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
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
Detailed Description:
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 379 per 100000 person-years for persons age 50 to 64 years1 patients with cancer were hospitalized at a rate of 219 per 100000 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 eg 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
A poor humoral immunogenicity has been shown for most available vaccines in haematological patients Especially affection of the B cell axis by either disease treatment or both impacts humoral vaccine immune response
The humoral vaccine-induced immune response facilitates early protection directly after vaccination while long-term protection warrants antibody persistence as well as immune memory cells Data from immunocompetent persons suggest that cell mediated immune response may be a better correlate of protection against virus in-fections in vaccinated patients with poor immune responses than humoral im-munity due to its major role in recovery from infection and in virus clearance
Immunologic data in patients with haematological malignancies are generally scarce and mainly focus on serologic parameters However cellular response and especially T cell response seems often to be induced more reliably in those patients than humoral response as seen in other immunocompromised populations18 and other vaccines
To close this knowledge gap we will perform an observational study to prospectively analyse the effect of early and late booster vaccination with special focus on the virus-specific T cells Samples will be collected from patients that have been vac-cinated as part of clinical routine
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 eg 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
A poor humoral immunogenicity has been shown for most available vaccines in haematological patients Especially affection of the B cell axis by either disease treatment or both impacts humoral vaccine immune response
The humoral vaccine-induced immune response facilitates early protection directly after vaccination while long-term protection warrants antibody persistence as well as immune memory cells Data from immunocompetent persons suggest that cell mediated immune response may be a better correlate of protection against virus in-fections in vaccinated patients with poor immune responses than humoral im-munity due to its major role in recovery from infection and in virus clearance
Immunologic data in patients with haematological malignancies are generally scarce and mainly focus on serologic parameters However cellular response and especially T cell response seems often to be induced more reliably in those patients than humoral response as seen in other immunocompromised populations18 and other vaccines
To close this knowledge gap we will perform an observational study to prospectively analyse the effect of early and late booster vaccination with special focus on the virus-specific T cells Samples will be collected from patients that have been vac-cinated as part of clinical routine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None