Tracking vaccine responses in older adults living with HIV
Vaccine Immunity and Inflammation in the Aging Person Living With HIV
This study is testing how well a pneumonia vaccine works over time in older adults living with HIV compared to younger people, to see if age and HIV affect their immune response.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hennepin Healthcare Research Institute Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06514547 on ClinicalTrials.gov |
What this trial studies
This study examines how age and HIV status affect immune responses to the conjugate pneumococcal vaccine over time. It focuses on individuals aged 50 and older living with HIV, as well as younger individuals with and without HIV, to understand the impact of chronic inflammation on vaccine efficacy. Participants will be monitored for both short-term and long-term immune responses following vaccination, allowing researchers to assess the durability of vaccine protection in this population. The study aims to fill gaps in existing research by including older adults who are often underrepresented in vaccine studies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older living with HIV who are on antiretroviral therapy and have a controlled viral load.
Not a fit: Patients with significant immunosuppressive conditions or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved vaccination strategies for older adults living with HIV, enhancing their immune protection.
How similar studies have performed: While there is existing research on vaccine responses in HIV populations, this specific focus on older adults and chronic inflammation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Minneapolis, Minnesota
- Hennepin Healthcare System — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Anne Frosch, MD
- Email: Anne.Frosch@hcmed.org
- Phone: (612)-283-4349
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.