Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00170508
Status:
COMPLETED
Last Update Posted:
2013-08-23
First Post:
2005-09-09
Brief Title:
Young Adult Influenza Vaccine Immunogenicity Substudy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
In Depth Immunologic Studies in Healthy Young Adults Who Receive The Standard Dose Fluzone 15mcgHAVirus Strain Trivalent Inactivated Influenza Virus Vaccine
Status:
COMPLETED
Status Verified Date:
2011-07
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:
This is a complimentary study to an elderly influenza study Subjects 18-40 will receive a single dose flu vaccine and be evaluated for humoral and cell mediated immunity to influenza antigens
Detailed Description:
The goals of this study are to provide in depth humoral and cellular immune responses to the standard-dose trivalent SV influenza virus vaccine containing 15 pg HA of each virus strain in healthy young adults Serum samples will be submitted for the following analysis measurement of serum anti-HA hemagglutinin IgG and IgA antibodies by ELISA IgG antibody subclasses IgG and IgA Avidity Virus neutralizing functional assay HAI antibody titer Peripheral blood mononuclear cells PBMC isolated from these subjects will be evaluated for the following central TCM and effector TEM memory T cell responses including their proliferative responses and cytokine production profiles by flow cytometry IFN-7 production by ELISPOT following specific antigenic stimulation Serum samples will be submitted for the following analysis measurement ex vivo of the frequency of circulating influenza-specificT cells by using commercially available MHCtetramers andor MHCpentamers and flow cytometry role of regulatory T cells in the modulation of influenza responses in young adults Fifteen healthy young adult subjects age 18-40 years inclusive will be recruited from the general population to be enrolled in this study No randomization or masking procedures will be used All eligible subjects will be administered one intramuscular IM injection of the same FDA approved standard-dose 15 mcg HA per strain trivalent inactivated influenza vaccine 2004-2005 season and key humoral and cell-mediated immunity CMI responses will be compared to those of elderly subjects enrolled under DMID 05-0028 On both Day 0 pre-vaccination and day 28 post-vaccination an 100 ml volume of whole blood will be obtained for a complete blood count CBC with differential and to isolate and cryopreserve serum and PBMCs This study will evaluate key humoral and cell-mediated immunity CMI responses in healthy young adults to establish a baseline immune response which will be used to evaluate changes associated with immunosenescence This study is linked to DMID protocol 05-0028
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Influenza CVD 12000 | None | None | None |