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Vaccine

Prevnar-13 Vaccine Response in Aging HIV Patients

Phase 4
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up a change from baseline, measured at pre-vaccination, and 1 month post vaccine
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am between 21-45 or 55-75 years old.
Select...
I have not received the Prevnar PCV-13 pneumococcal vaccine.

Timeline

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine pneumococcal specific IgG levels in BAL (BronchoAlveolar Lavage) fluid and NPF (Nasopharyngeal Fluid)
Determine pneumococcal specific IgG levels in serum

Trial Design

2Treatment groups
Active Control
Group I: HIV+Active Control1 Intervention
One time administration of Prevnar-13 vaccine to HIV+ participants
Group II: HIV Negative ControlsActive Control1 Intervention
One time administration of Prevnar-13 vaccine to HIV Negative Control participants

Find a Location

Who is running the clinical trial?

VA Eastern Colorado Health Care SystemLead Sponsor
53 Previous Clinical Trials
26,078 Total Patients Enrolled
Edward N Janoff, MDPrincipal InvestigatorUniversity of Colorado Anschutz; Rocky Mountain Regional VAMC
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Prevnar-13 (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03729778 — Phase 4
Human Immunodeficiency Virus Infection Research Study Groups: HIV+, HIV Negative Controls
Human Immunodeficiency Virus Infection Clinical Trial 2023: Prevnar-13 Highlights & Side Effects. Trial Name: NCT03729778 — Phase 4
Prevnar-13 (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03729778 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~12 spots leftby Apr 2025