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NCT Number: NCT06514547

Vaccine Immunity and Inflammation in the Aging Person Living With HIV

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hennepin Healthcare System

Minneapolis, Minnesota, 55415, United States

Location status: Recruiting

Location contact

Anne Frosch, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conjugate Pneumococcal Vaccine 20 (PCV20)

Biological

Vaccine

Other names: Prevnar20

Primary outcomes

  1. 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

  1. Secondary objective

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Frosch, MD

CONTACT

[email protected]

(612)-283-4349

Marya Abd El Hadi, BSc

CONTACT

[email protected]

(612)-873-6252

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: VIVID

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jul 23, 2024
Registry last updated
Jun 12, 2025

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.

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