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Flu shot study seeks clues in HIV and aging

NCT ID NCT04487041

Knowledge-focused Sponsor: University of Miami Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study looks at blood samples from 400 people with and without HIV to understand how aging and HIV infection change the body's immune response to the flu vaccine. Researchers will measure antibody levels and immune cell types to see who responds well to the vaccine and who does not. The goal is to learn more, not to test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2020

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

HIV infectious disease influenza

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Human influenza

Contacts and locations

Locations

  • University of Miami

    Miami, Florida, 33136, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.