Ignite Creation Date:
2024-07-17 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501963
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-09
Brief Title:
Revealing Protective Immunity to Influenza Using Systems Immunology
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Revealing Protective Immunity to Influenza Using Systems Immunology
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRISM
Brief Summary:
The goals of this study are to better understand the human immune response to influenza vaccines specifically the live attenuated weakened influenza vaccine given as a nasal spray Better understanding why this vaccine does not work as well in adults as it does in children may help design better influenza vaccines
Detailed Description:
Influenza flu viruses cause significant disease and death every year Influenza vaccines protect against illness but their effectiveness can be limited The influenza virus is notorious for its continuous mutation and potential to cause pandemics This essentially creates a moving target for vaccine development posing a significant challenge for global health Current vaccines offer a certain degree of protection but are not fully effective due to the viruss ever-changing nature In response to this a live attenuated influenza vaccine LAIV was developed with the objective of providing a higher degree of protection This type of vaccine has demonstrated remarkable effectiveness in children surpassing the protection provided by inactivated flu vaccines This made LAIV a preferred choice for administration to young children
However when it comes to adults individuals over 18 years of age the scenario is markedly different Recent studies have indicated a significant decline in LAIVs effectiveness in adults compared to children Various clinical trials have reported that LAIV exhibits approximately 85 efficacy in children under the age of 18 which dramatically decreases to around 40-60 in adults aged 18-49 years This suggests that adults do not respond as well to LAIV as children do In adults the LAIV-induced immunity appears to be short-lived often lasting for only one influenza season while in children LAIV has shown to provide long-lasting protection even against mismatched strains Understanding the factors behind this discrepancy is critical to improve the protective efficacy of influenza vaccines across all age brackets Unraveling this mystery could open the doors to the development of a superior flu vaccine one that offers robust protection across all age groups
This study will enroll healthy adult age 18-49 participants who have not received the influenza vaccine recently Participants will be asked to come in for 3 visits over 1 month Participants will receive the FDA-approved live attenuated influenza vaccine given as a nasal spray Study staff will collect baseline and follow-up biologic samples to compare how the immune system reacts The biologic samples will be collected from the blood and nose to look at immune cells in these parts of the body
However when it comes to adults individuals over 18 years of age the scenario is markedly different Recent studies have indicated a significant decline in LAIVs effectiveness in adults compared to children Various clinical trials have reported that LAIV exhibits approximately 85 efficacy in children under the age of 18 which dramatically decreases to around 40-60 in adults aged 18-49 years This suggests that adults do not respond as well to LAIV as children do In adults the LAIV-induced immunity appears to be short-lived often lasting for only one influenza season while in children LAIV has shown to provide long-lasting protection even against mismatched strains Understanding the factors behind this discrepancy is critical to improve the protective efficacy of influenza vaccines across all age brackets Unraveling this mystery could open the doors to the development of a superior flu vaccine one that offers robust protection across all age groups
This study will enroll healthy adult age 18-49 participants who have not received the influenza vaccine recently Participants will be asked to come in for 3 visits over 1 month Participants will receive the FDA-approved live attenuated influenza vaccine given as a nasal spray Study staff will collect baseline and follow-up biologic samples to compare how the immune system reacts The biologic samples will be collected from the blood and nose to look at immune cells in these parts of the body
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None