Vaccine Immunity and Inflammation in the Aging Person Living With HIV
Overview
- Phase
- Phase 4
- Intervention
- Conjugate Pneumococcal Vaccine 20 (PCV20)
- Conditions
- HIV Infections
- Sponsor
- Hennepin Healthcare Research Institute
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Primary objective
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
Anne Frosch
Principal Investigator
Hennepin Healthcare Research Institute
Eligibility Criteria
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:
Arms & Interventions
Pneumococcal Vaccination
All participants will receive a pneumococcal vaccine.
Intervention: Conjugate Pneumococcal Vaccine 20 (PCV20)
Outcomes
Primary Outcomes
Primary objective
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.
Secondary Outcomes
- Secondary objective(30 days and 2 years)