Recruiting

Pneumococcal Vaccines

Sponsor:

Hennepin Healthcare Research Institute

Code:

NCT06514547

Conditions

HIV Infections

Age

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Conjugate Pneumococcal Vaccine 20 (PCV20)

Study Details

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

Study ID

NCT06514547

Start date

Jul 8, 2024

Status verified date

Jun, 2025

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Sep 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

250 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Pneumococcal Vaccination

All participants will receive a pneumococcal vaccine.

Interventions

Conjugate Pneumococcal Vaccine 20 (PCV20)

Vaccine

Primary outcome measure

  • Primary objective [ Time Frame: 30 days and 2 years ]

Central Contacts and Locations

Central contacts

Anne Frosch, MD

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

Marya Abd El Hadi, BSc

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

Locations

Hennepin Healthcare System

Recruiting

Minneapolis, Minnesota, United States, 55415

More Information

Sponsor

Hennepin Healthcare Research Institute

Last update posted

Jun 12, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hennepin Healthcare Research Institute on 2025-06-12.