Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05921448
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2023-06-18
Brief Title:
Vaccine Pandemic Preparedness Through Airway Immunology Characterization
Sponsor:
Chronic Obstructive Pulmonary Disease Trial Network Denmark
Organization:
Chronic Obstructive Pulmonary Disease Trial Network Denmark
Study Overview
Official Title:
In-depth Immunological Analysis of Airway Immunity Following Nasal Live Attenuated and Intramuscular Influenza Vaccine
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
VAXXAIR
Brief Summary:
The study aims to compare the effectiveness of live attenuated influenza vaccines LAIV and intramuscular-inactivated vaccines IIV in healthy individuals aged 18-49 It will investigate cellular and humoral responses identify immunological markers for targeted vaccine improvement and establish a collaborative platform for accelerated immunological and clinical vaccine research
Detailed Description:
There are several types of vaccines and the focus on the important role of vaccines in health has increased after the SARS-CoV-2 pandemic Therefore it is desired to investigate whether so-called live attenuated influenza vaccines LAIV can prove more effective than the most frequently used intramuscular-inactivated vaccines IIV
Several studies have previously compared the humoral and cellular response to LAIV and IIV and some of these have shown that LAIV elicits a more robust cellular response than intramuscularly administered vaccines
In the study the immunological differences in cellular and humoral response following vaccination either intramuscularly or nasally will be characterized The patient group will consist of healthy individuals between 18-49 years of age It is further desired to identify immunological markers that vaccines can be directed against in order to improve the immunological response Finally a platform for collaboration on accelerated immunological and clinical vaccine research will be established
The study is a randomized double-blind placebo-controlled study It is carried out in several locations and is Good Clinical Practice monitored
Several studies have previously compared the humoral and cellular response to LAIV and IIV and some of these have shown that LAIV elicits a more robust cellular response than intramuscularly administered vaccines
In the study the immunological differences in cellular and humoral response following vaccination either intramuscularly or nasally will be characterized The patient group will consist of healthy individuals between 18-49 years of age It is further desired to identify immunological markers that vaccines can be directed against in order to improve the immunological response Finally a platform for collaboration on accelerated immunological and clinical vaccine research will be established
The study is a randomized double-blind placebo-controlled study It is carried out in several locations and is Good Clinical Practice monitored
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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