Impact of HIV-1 and Aging on Mucosal Vaccine Responses

NCT03729778 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 16-1919
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

HIV+

ACTIVE COMPARATOR

One time administration of Prevnar-13 vaccine to HIV+ participants

Biological: Prevnar-13

HIV Negative Controls

ACTIVE COMPARATOR

One time administration of Prevnar-13 vaccine to HIV Negative Control participants

Biological: Prevnar-13

Interventions

Prevnar-13 BIOLOGICAL

One time administration of prevnar-13 vaccine

HIV Negative Controls; HIV+

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Eastern Colorado Health Care System: lead

Study Sites (1)

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

Location

Related Publications (4)

• 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.

  PMID: 15995950 RESULT

• 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.

  PMID: 21150868 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.

  PMID: 22048728 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.

  PMID: 25785969 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections; Pneumococcal Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Edward N Janoff, MD

  University of Colorado Anschutz; Rocky Mountain Regional VAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants with be given a screening number and a participant number as a unique identifier that does not involve their name.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: November 5, 2018
• Study Start: January 18, 2017
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 15, 2024

Record last verified: 2024-06

Locations

US (1)