HIV InfectionsPhase 4VIVIDNCT06514547
Vaccine Immunity and Inflammation in the Aging Person Living With HIV
A Phase 4 study testing Conjugate Pneumococcal Vaccine 20 (PCV20) in people with HIV Infections and Age, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Age
- What is being tested?
- Conjugate Pneumococcal Vaccine 20 (PCV20)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2024to 30 Jun 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age>=18 years
- HIV Diagnosis
- On Antiretroviral Therapy with HIV Viral Load<200 within last year
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hennepin Healthcare System
Minneapolis, Minnesota, 55415
Anne Frosch, MD
About this study
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.
Read the 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.
- Conditions
- HIV Infections, Age
- Being tested
- Conjugate Pneumococcal Vaccine 20 (PCV20)
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conjugate Pneumococcal Vaccine 20 (PCV20)Biological
Also called Prevnar20
Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Pneumococcal Vaccination | Experimental | All participants will receive a pneumococcal vaccine. Receives: Biological: Conjugate Pneumococcal Vaccine 20 (PCV20) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days and 2 years
Secondary outcomes (1)
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.
Measured: 30 days and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start8 Jul 2024
- Primary completion15 Sep 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Anne Frosch, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514547
- Sponsor's protocol ID
- FY2024-738
- Other IDs
- 1R01AG084437-01A1
- Acronym
- VIVID
- Status last verified
- Jun 2025
- First submitted
- 12 Jul 2024
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccine Immunity and Inflammation in the Aging Person Living With HIV
- ClinicalTrials.gov ID
- NCT06514547
- Acronym / sponsor ID
- VIVID / FY2024-738
- Conditions
- HIV Infections, Age
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pneumococcal Vaccination | Experimental | Biological: Conjugate Pneumococcal Vaccine 20 (PCV20)All participants will receive a pneumococcal vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age>=18 years
- HIV Diagnosis
- On Antiretroviral Therapy with HIV Viral Load<200 within last year
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conjugate Pneumococcal Vaccine 20 (PCV20)Also: Prevnar20Vaccine | Biological | Pneumococcal Vaccination |
Primary outcome
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.
1 secondary outcome
Secondary objective
Time frame: 30 days and 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conjugate Pneumococcal Vaccine 20 (PCV20) in people with HIV Infections and Age, run by Hennepin Healthcare Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Frosch, MD ((612)-283-4349, Anne.Frosch@hcmed.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective (time frame: 30 days and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.