Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597916
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
RSV Vaccination in Immunocompromised Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase-2b Controlled Study to Evaluate the Humoral and Cellular Immune Response and Safety Following One and Two Doses of an Adjuvanted RSV Subunit Vaccine in Immunocompromised Patients Aged 18 Years and Older
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:
None
Brief Summary:
Respiratory syncytial Virus RSV causes respiratory infections worldwide and typically presents with a seasonal pattern peaking in autumnwinter in temperate climate zones Apart from infants and elderly individuals patients with underlying substantial respiratory cardiovascular endocrinological diseases and immunocompromised patients are at increased risk to develop lower respiratory tract infection LRTI requiring intensive care associated with increased mortality For certain risk groups such as patients after hematologic stem cell transplantation HSCT in-hospital mortality may be as high as 70 A causally related RSV specific treatment does not exist and treatment is therefore usually supportive and non-specific
The study is aiming to determine if immunocompromised patients benefit from two doses of a RSV subunit vaccine as opposed to one dose The additional dose will be administered off label
The study is aiming to determine if immunocompromised patients benefit from two doses of a RSV subunit vaccine as opposed to one dose The additional dose will be administered off label
Detailed Description:
The aim of this study is to assess immunogenicity and safety of the adjuvanted RSV vaccine Arexvy in different cohorts of immunocompromised patients These data are needed as a basis for RSV vaccine recommendations
Currently one dose of the RSV vaccine is recommended for the elderly 60 years according to the SmPC and national recommendations However it is not clear yet whether in immunocompromised patients such as those with solid tumors hemato-oncological malignancies with and without hematopoietic stem cell transplantation HSCT or those with biological treatments one dose of RSV vaccine would be sufficient to induce immune responses or if these patients would benefit from a second dose
It is planned to evaluate immune responses after one and two doses with the adjuvanted RSV vaccine Arexvy in immunocompromised study groups compared to responses of healthy elderly individuals receiving one vaccine dose only Our analysis plan will include humoral and cellular immune responses after the first and second dose in immunocompromised patients belonging to different study groups compared to responses after one vaccine dose in controls
Currently one dose of the RSV vaccine is recommended for the elderly 60 years according to the SmPC and national recommendations However it is not clear yet whether in immunocompromised patients such as those with solid tumors hemato-oncological malignancies with and without hematopoietic stem cell transplantation HSCT or those with biological treatments one dose of RSV vaccine would be sufficient to induce immune responses or if these patients would benefit from a second dose
It is planned to evaluate immune responses after one and two doses with the adjuvanted RSV vaccine Arexvy in immunocompromised study groups compared to responses of healthy elderly individuals receiving one vaccine dose only Our analysis plan will include humoral and cellular immune responses after the first and second dose in immunocompromised patients belonging to different study groups compared to responses after one vaccine dose in controls
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