Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514547
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Vaccine Immunity and Inflammation in the Aging Person Living With HIV
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Vaccine Immunity and Inflammation in the Aging Person Living With HIV
Status:
RECRUITING
Status Verified Date:
2024-07
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:
VIVID
Brief Summary:
This study will track immune responsiveness to conjugate pneumococcal vaccines over time to help determine how long protection from this vaccine lasts in individuals with chronic medical conditions in this study - HIV and with age
Detailed Description:
Persons living with HIV PLWH are at increased risk of chronic inflammation and the associated adverse health outcomes There is considerable evidence that chronic inflammatory conditions like metabolic disease and autoimmune disorders as associated with weakened vaccine responses and existing vaccine studies in PLWH do not adequately sample older individuals who are disproportionately affected by this inflammaging We hypothesize the effect of age on poor vaccine responses is greater among PLWH given the additional burdens of HIV driven inflammation The overall project goal is to examine this premise by measuring the impact of HIV status age and chronic immune activation on conjugate pneumococcal vaccine responses We will study acute 30 day and longer-term 2 year immune responses following PCV vaccination among a cohort of participants including 4 groups a older PLWH age 50 n100 b older HIV uninfected controls age 50 n50 c younger PLWH age 50 n50 d younger HIV uninfected controls age 50 n50 With these cohorts we will 1 Comprehensively characterize the impact of HIV and age on the immunogenicity of conjugate pneumococcal vaccination by longitudinally tracking adaptive vaccine-specific antibody B cell and cluster of differentiation 4 T cell responses We will compare these responses by age and HIV status We will also 2 Determine the influence of chronic inflammation on vaccine-specific immunity among PLWH across the adult lifespan by measuring the associate between vaccine immunity and biomarkers of chronic inflammation This project will provide valuable knowledge on how HIV and age influence vaccine immune responses with the hope of informing vaccine development and schedule to optimize the long-term health of persons living with HIV
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