Your session is about to expire
← Back to Search
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 belowSelect...
I am between 21-45 or 55-75 years old.
Select...
I have not received the Prevnar PCV-13 pneumococcal vaccine.
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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 21-45 or 55-75 years old.I have not received the Prevnar PCV-13 pneumococcal vaccine.I can attend 2-3 study visits over a month.My kidney function is impaired (creatinine ≥ 2.0 mg/dL).I have had my spleen removed.I have an ongoing liver condition.I am currently taking steroids, chemotherapy, immunosuppressants, or using illicit drugs.
Research Study Groups:
This trial has the following groups:- Group 1: HIV+
- Group 2: HIV Negative Controls
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Share this study with friends
Copy Link
Messenger