Evaluating how HIV and aging affect immune responses to flu vaccination
Tfh Dysfunction in HIV and Aging
This study tests how aging and HIV affect how well different flu vaccines work for people, to help improve vaccination strategies for those groups.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT04487041 on ClinicalTrials.gov |
What this trial studies
This research evaluates blood samples from individuals infected with HIV and those who are not, focusing on how aging and HIV influence immune responses to the flu vaccine. Participants will receive either a standard or high dose influenza vaccination to assess the effectiveness of these vaccines in different age groups. The study aims to understand the immune function in relation to HIV and aging, which could inform better vaccination strategies for these populations.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 35 years or younger and 65 years or older, both HIV positive and negative, with specific health criteria.
Not a fit: Patients with active malignancies or those on immunosuppressive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved flu vaccination strategies for older adults and those living with HIV.
How similar studies have performed: Other studies have explored immune responses to vaccinations in similar populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. For HIV positive participants:
* HIV infection, as documented by any licensed ELISA test kit. Participants on ART as a result of prior HIV documented infection will not be required to provide proof of diagnosis of HIV infection.
* Additional criteria for HIV positive
1. on ART for at least 1 year. Occasional viral blips up to 1000 copies/ml also acceptable provided the patients are on continuing treatment,
2. Cluster of differentiation 4 (CD4) count available in the prior 6 months and \>200/mm3
3. Undetectable viral load (\< 40 copies/mL). Blips of \<1000 copies/mL will be allowed.
2. For HIV negative participants:
* Documented negative HIV test at the time of study entry, either by any licensed ELISA.
3. For all participants:
1. Individuals age: ≤35 years and ≥65 years.
2. No history of other immunodeficiency disorders
3. Not on steroid or other immunosuppressive/immunomodulators medications.
4. No active malignancies.
5. Agreeable to receive both regular standard (STD-TIV) and high dose (HD-TIV) influenza vaccination.
6. Agreeable to participate in study for a complete course of study full visits including 2 consecutive flu seasons.
7. Able to provide informed consent.
Exclusion criteria
1. Contraindication to receive influenza vaccination.
2. Non-adherence to ART for HIV positive
3. Unable to provide informed consent.
4. Influenza vaccination already given during the current vaccination season.
5. Known drug abuse including cocaine by history
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Savita Pahwa, MD — University of Miami
- Study coordinator: Suresh Pallikkuth, PhD
- Email: spallikkuth@med.miami.edu
- Phone: 3052435315
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.