NCT06514547 · Hennepin Healthcare Research Institute
Vaccine Immunity and Inflammation in the Aging Person Living With HIV
(VIVID)
What this study is about
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.
View original scientific description
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.
Interventions
BIOLOGICAL
Conjugate Pneumococcal Vaccine 20 (PCV20)
Vaccine
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Minneapolis, Minnesota
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 12, 2025 · Source of record for eligibility and locations