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Could HIV and age weaken vaccine protection? study investigates

NCT ID NCT03729778

Knowledge-focused Sponsor: VA Eastern Colorado Health Care System Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This study looks at how HIV infection and aging impact the body's response to the Prevnar 13 vaccine, which protects against pneumococcal bacteria. Researchers will measure antibody levels in the lungs, nasal passages, and blood of participants aged 21-45 or 55-75, comparing those with and without HIV. The goal is to understand why these groups face higher risks of serious infections and whether their immune systems respond differently to vaccination.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Prevnar 13 vaccine
What this could lead to
If successful, this could help tailor vaccination strategies for people with HIV and older adults, potentially reducing their risk of serious infections.
What could go wrong
This is an early-phase study with a small sample size, so results may not apply broadly. The vaccine's effectiveness in these groups remains uncertain.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 100 people

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

Started

Jan 2017

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

21 to 75 years

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: * Veterans only (accessibility to non-veterans pending) * Age 21-45 or 55-75 Years Old * Have not received pneumococcal vaccine Prevnar PCV-13 * Able to attend 2-3 study visits over 1 month HIV+: -Undetectable Viral load HIV negative controls: -no history or risks for HIV infection Exclusion Criteria: * Spleen removed * Chronic Kidney disease (creatinine ≥ 2.0 mg/dL) * Active liver disease * Currently taking: Corticosteroids (prednisone, medrol, etc), Chemotherapy, Immunosuppressive medication (cyclosporine, methotrexate, azathioprine, infliximab, adalimumab, rituximab, etanercept, etc), or illicit drugs (methamphetamine, cocaine, crack, or heroin)

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease pneumococcal infection

As listed by the trial registrant

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

HIV infections HIV-1-infection HIV/AIDS Human immunodeficiency virus

Contacts and locations

Locations

  • Rocky Mountain Regional VA Medical Center

    Aurora, Colorado, 80045, United States

More trials for these conditions

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