HIV-1-infection, HIV/AIDS, HIV Infections, Human Immunodeficiency Virus
Conditions
Keywords
HIV, Streptococcus pneumoniae infection, Prevnar-13, PCV-13, Pneumococcal vaccine, Pneumococcal vaccines, Streptococcus pneumoniae colonization
Brief summary
The purpose of this study is to learn more about both HIV-1 infection and advancing age, and their association with increased risk of serious infection and impaired response to the Prevnar 13 vaccine.
Detailed description
After being informed about the study and potential risks, patients will be screened to determine eligibility for the study and consented. Patients who meet eligibility requirements will be immunized with PCV 20. HIV-infected adults will be tested prior to and after vaccination by blood, nasal filter paper, and stool samples to characterize mucosal and systemic antibody responses . HIV-uninfected control adults will be tested at vaccination and post vaccination to characterize mucosal and systemic antibody responses .
Interventions
BIOLOGICALPrevnar-13
One time administration of prevnar-13 vaccine
Sponsors
VA Eastern Colorado Health Care System
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Masking description
Participants with be given a screening number and a participant number as a unique identifier that does not involve their name.
Intervention model description
Healthy control and HIV-1-infected adults aged 21-45 and 55-75 years old. For HIV-1+ undetectable plasma HIV-1 RNA and documented PPSV23. Two-time blood draw, nasopharyngeal fluid collection, physical function test, fecal collection and questionnaire. Participants will be given PCV13.
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine pneumococcal specific IgG levels in BAL (BronchoAlveolar Lavage) fluid and NPF (Nasopharyngeal Fluid) | A change from baseline, measured at pre-vaccination, and 1 month post vaccine | Determine pneumococcal specific IgG levels in BAL fluid and NPF and to standardize the results we will compare it to the total levels in the BAL/NPF fluid collected at all timepoints |
| Determine pneumococcal specific IgG levels in serum | A change from baseline, measured at pre-vaccination, and 1 month post vaccine | Determine pneumococcal specific IgG levels in serum 1 month post vaccination response criteria must meet \>2-fold rise with a post-vaccination level \>1000 ng/ml for \> 7 of the 12 serotypes |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREdward N Janoff, MD
University of Colorado Anschutz; Rocky Mountain Regional VAMC
Outcome results
None listed