Prevnar-13 Vaccine Response in Aging HIV Patients

Phase < 1

Waitlist Available

Led By Edward N Janoff, MD

Research Sponsored by VA Eastern Colorado Health Care System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 21-45 or 55-75 Years Old

Have not received pneumococcal vaccine Prevnar PCV-13

Must not have

Chronic Kidney disease (creatinine ≥ 2.0 mg/dL)

Spleen removed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up a change from baseline, measured at pre-vaccination, and 1 month post vaccine

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial looks at HIV-1, aging, & their impact on infection risk & vaccine response.

Who is the study for?

This trial is for veterans aged 21-45 or 55-75 with HIV but no history of serious infections, who haven't had the Prevnar PCV-13 vaccine. Participants must have an undetectable viral load and be able to attend a few study visits over a month. Those with chronic kidney disease, active liver issues, no spleen, or on certain medications like steroids or immunosuppressants can't join.

What is being tested?

The study aims to understand how HIV and aging affect the body's response to the Prevnar 13 vaccine, which helps prevent pneumonia and other diseases caused by pneumococcal bacteria.

What are the potential side effects?

While not specified here, common side effects of vaccines like Prevnar may include pain at injection site, fatigue, headache, muscle pain, joint pain, decreased appetite among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21-45 or 55-75 years old.

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I have not received the Prevnar PCV-13 pneumococcal vaccine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is impaired (creatinine ≥ 2.0 mg/dL).

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I have had my spleen removed.

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I have an ongoing liver condition.

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I am currently taking steroids, chemotherapy, immunosuppressants, or using illicit drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ a change from baseline, measured at pre-vaccination, and 1 month post vaccine

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~a change from baseline, measured at pre-vaccination, and 1 month post vaccine

This trial's timeline: 3 weeks for screening, Varies for treatment, and a change from baseline, measured at pre-vaccination, and 1 month post vaccine for reporting.