Vaccine Immunity and Inflammation in the Aging Person Living With HIV (VIVID)

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Infections; Age
• Intervention / Treatment: Biological: Conjugate Pneumococcal Vaccine 20 (PCV20)

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Anne Frosch, MD; Phone Number: (612)-283-4349; Email: Anne.Frosch@hcmed.org
• Study Contact Backup: Name: Marya Abd El Hadi, BSc; Phone Number: (612)-873-6252; Email: MAbdElHadi@hhrinstitute.org

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Recruiting
      • Hennepin Healthcare System
      • Contact: Anne Frosch, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pneumococcal Vaccination; All participants will receive a pneumococcal vaccine.	Biological: Conjugate Pneumococcal Vaccine 20 (PCV20); Vaccine; Other Names: Prevnar20

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary objective	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.	30 days and 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary objective	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.	30 days and 2 years

Collaborators and Investigators

• Sponsor: Hennepin Healthcare Research Institute
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2024
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Immunologic Factors; Physiological Effects of Drugs; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: FY2024-738; 1R01AG084437-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No