Hennepin Healthcare System
Minneapolis, Minnesota, 55415, United States
Location status: Recruiting
Location contact
Anne Frosch, MD
CONTACT
NCT Number: NCT06514547
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Minneapolis, Minnesota, 55415, United States
Location status: Recruiting
Anne Frosch, MD
CONTACT
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 (n=100), b) older HIV uninfected controls, age ≥50 (n=50), c) younger PLWH, age <50 (n=50), d) younger HIV uninfected controls, age <50 (n=50). 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Controls inclusion criteria:
Vaccine
Other names: Prevnar20
Time frame: 30 days and 2 years
Evaluate the impact of HIV status on pneumococcal vaccine immunogenicity and durability as measured pneumococcal-specific Ab concentration, memory B cell responses (frequency and phenotype) and CD4 T cell responses (frequency and phenotype) at an acute (primary comparison) and memory (secondary comparison) post-vaccination timepoints.
Time frame: 30 days and 2 years
Explore the impact of advanced age on pneumococcal vaccine immunogenicity and durability in PLWH. This will be evaluated by evaluating the relationship of age and pneumococcal-specific Ab concentration, memory B cell responses (frequency and phenotype) and CD4 T cell responses (frequency and phenotype) at acute and memory timepoints.
Contact information is provided by the study sponsor or research team.
Anne Frosch, MD
CONTACT
Marya Abd El Hadi, BSc
CONTACT
Hennepin Healthcare Research Institute
Other
Acronym: VIVID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07737340
Blood-Borne Infections, Communicable Diseases
Ankara, Turkey (Türkiye)
View Trial DetailsNCT07728123
Blood-Borne Infections, Communicable Diseases
Tampa, Florida, United States
View Trial DetailsNCT07473778
Blood-Borne Infections, Communicable Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT07682961
Blood-Borne Infections, Communicable Diseases
Fort Lauderdale, Florida, United States
View Trial Details