Clinical trial NCT03729778: Impact of HIV-1 and Aging on Mucosal Vaccine Responses
Official title: Impact of HIV-1 and Aging on Mucosal Vaccine Responses
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: HIV-1-infection
Human Immunodeficiency Virus
HIV/AIDS
HIV Infections
Keywords: HIV
Streptococcus pneumoniae infection
Prevnar-13
PCV-13
Pneumococcal vaccine
Pneumococcal vaccines
Streptococcus pneumoniae colonization
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
First posted: 2018-11-05
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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 .

Eligibility criteria: 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)

Primary outcomes:
measure: Determine pneumococcal specific IgG levels in BAL (BronchoAlveolar Lavage) fluid and NPF (Nasopharyngeal Fluid)
timeFrame: A change from baseline, measured at pre-vaccination, and 1 month post vaccine
measure: Determine pneumococcal specific IgG levels in serum
timeFrame: A change from baseline, measured at pre-vaccination, and 1 month post vaccine
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center
state: Colorado
Study officials:
affiliation: University of Colorado Anschutz; Rocky Mountain Regional VAMC
name: Edward N Janoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.