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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.
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV+ | Active Comparator | One time administration of Prevnar-13 vaccine to HIV+ participants |
|
| HIV Negative Controls | Active Comparator | One time administration of Prevnar-13 vaccine to HIV Negative Control participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevnar-13 | Biological | One time administration of prevnar-13 vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine pneumococcal specific IgG levels in BAL (BronchoAlveolar Lavage) fluid and NPF (Nasopharyngeal Fluid) | 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 | A change from baseline, measured at pre-vaccination, and 1 month post vaccine |
| Determine pneumococcal specific IgG levels in serum | 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 | A change from baseline, measured at pre-vaccination, and 1 month post vaccine |
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Inclusion Criteria:
HIV+:
-Undetectable Viral load
HIV negative controls:
-no history or risks for HIV infection
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward N Janoff, MD | University of Colorado Anschutz; Rocky Mountain Regional VAMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Regional VA Medical Center | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15995950 | Result | Kyaw MH, Rose CE Jr, Fry AM, Singleton JA, Moore Z, Zell ER, Whitney CG; Active Bacterial Core Surveillance Program of the Emerging Infections Program Network. The influence of chronic illnesses on the incidence of invasive pneumococcal disease in adults. J Infect Dis. 2005 Aug 1;192(3):377-86. doi: 10.1086/431521. Epub 2005 Jun 23. | |
| 21150868 |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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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.
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Participants with be given a screening number and a participant number as a unique identifier that does not involve their name.
| Nuorti JP, Whitney CG; Centers for Disease Control and Prevention (CDC). Prevention of pneumococcal disease among infants and children - use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine - recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2010 Dec 10;59(RR-11):1-18. |
| 22048728 | Result | Centers for Disease Control and Prevention (CDC). Invasive pneumococcal disease and 13-valent pneumococcal conjugate vaccine (PCV13) coverage among children aged </=59 months---selected U.S. regions, 2010--2011. MMWR Morb Mortal Wkly Rep. 2011 Nov 4;60(43):1477-81. |
| 25785969 | Result | Bonten MJ, Huijts SM, Bolkenbaas M, Webber C, Patterson S, Gault S, van Werkhoven CH, van Deursen AM, Sanders EA, Verheij TJ, Patton M, McDonough A, Moradoghli-Haftvani A, Smith H, Mellelieu T, Pride MW, Crowther G, Schmoele-Thoma B, Scott DA, Jansen KU, Lobatto R, Oosterman B, Visser N, Caspers E, Smorenburg A, Emini EA, Gruber WC, Grobbee DE. Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults. N Engl J Med. 2015 Mar 19;372(12):1114-25. doi: 10.1056/NEJMoa1408544. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |