Age, HIV Infections
Conditions
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 (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.
Interventions
BIOLOGICALConjugate Pneumococcal Vaccine 20 (PCV20)
Vaccine
Sponsors
National Institute on Aging (NIA)
Hennepin Healthcare Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
1\) Some participants will receive this vaccine as part of routine clinical care, and we will coordinate our study visits based on the receipt of that vaccine. 2) Some participants will receive this vaccine outside of the Centers for Disease Control and Prevention recommended schedule, but as in accordance with FDA approved use and 3) Some participant who are receiving this vaccination outside of current FDA approval for a single dose in those above 18 by receiving a second dose.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age\>=18 years * HIV Diagnosis * On Antiretroviral Therapy with HIV Viral Load\<200 within last year
Exclusion criteria
* Other significant immunosuppressing condition * Age\< 18 years * Pregnancy (at enrollment) * Contraindication to pneumococcal vaccination * Known contraindication to non-clinical blood draws (severe anemia last hemoglobin \<8g/dl) * Subjects who, in the opinion of the Investigator, may be non-adherent to study schedules or procedures. * Adults unable to consent * Individuals with impaired ability to consent * Incarceration at time of enrollment Controls inclusion criteria: * Age\>=18 years * HIV Ag-Ab test negative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary objective | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary objective | 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. |
Countries
United States
Contacts
Primary ContactAnne Frosch, MD
Backup ContactMarya Abd El Hadi, BSc
Outcome results
None listed