Vaccine Immunity and Inflammation in the Aging Person Living With HIV

NCT06514547 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: FY2024-7381R01AG084437-01A1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Age

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary objective

  30 days and 2 years

Study Arms (1)

Pneumococcal Vaccination

EXPERIMENTAL

All participants will receive a pneumococcal vaccine.

Biological: Conjugate Pneumococcal Vaccine 20 (PCV20)

Interventions

Conjugate Pneumococcal Vaccine 20 (PCV20) BIOLOGICAL

Vaccine

Also known as: Prevnar20

Pneumococcal Vaccination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>=18 years
• HIV Diagnosis
• On Antiretroviral Therapy with HIV Viral Load\<200 within last year

You may not qualify if:

• 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
• Age\>=18 years
• HIV Ag-Ab test negative

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Hennepin Healthcare System

Minneapolis, Minnesota, 55415, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Anne Frosch, MD

CONTACT

(612)-283-4349; Anne.Frosch@hcmed.org

Marya Abd El Hadi, BSc

CONTACT

(612)-873-6252; MAbdElHadi@hhrinstitute.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 23, 2024
• Study Start: July 8, 2024
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

US (1)