Mechanisms of Impaired HIV-associated B Cell and Pneumococcal Vaccine Responses
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Pneumonia, Vaccines, Infectious Disease, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 6/10/2018 |
| Start Date: | August 2014 |
| End Date: | June 2019 |
Human Immunodeficiency Virus (HIV) infection is complicated by high rates of infections and
cancers which are often the cause of death rather than the HIV/acquired immune deficiency
syndrome (AIDS) virus itself. Treatment of HIV with antiretroviral medications has decreased
the frequency of many complications by over 90%, but bacterial pneumonia remains extremely
high. Current vaccines are not very effective in preventing these infections in patients with
HIV infection. The investigators are studying the cells (B cells) that make antibodies to
fight infection by binding to and killing bacteria. The goal is to understand how HIV impairs
the ability of B cells to make antibodies in sufficient quantity and of sufficient quality to
protect patients with HIV to learn how to enhance protection against these infections. The
investigators also seek to understand the role of the bacteria (specifically Streptococcus
pneumoniae) that normally live in the nose and throat in the development of pneumonia and
other infections.
cancers which are often the cause of death rather than the HIV/acquired immune deficiency
syndrome (AIDS) virus itself. Treatment of HIV with antiretroviral medications has decreased
the frequency of many complications by over 90%, but bacterial pneumonia remains extremely
high. Current vaccines are not very effective in preventing these infections in patients with
HIV infection. The investigators are studying the cells (B cells) that make antibodies to
fight infection by binding to and killing bacteria. The goal is to understand how HIV impairs
the ability of B cells to make antibodies in sufficient quantity and of sufficient quality to
protect patients with HIV to learn how to enhance protection against these infections. The
investigators also seek to understand the role of the bacteria (specifically Streptococcus
pneumoniae) that normally live in the nose and throat in the development of pneumonia and
other infections.
Inclusion Criteria:
For HIV-infected subjects:
- adults aged 18-55 years
- >200 CD4+ T-cells/microliter
- no antiretroviral therapy (at the time of nasal swab/week 0)
- receiving antiretroviral therapy for >6 weeks (at the time of vaccination/week 12)
For HIV-seronegative controls:
- adults aged 18-55 years
Exclusion Criteria:
For all subjects:
- age <18 or >55 years
- history of prior pneumococcal vaccination
- immunosuppressive therapy, defined as: prednisone >15mg/day currently or >14 days in
the past 3 months, cytotoxic agents, anti-metabolites, cyclosporine, anti-tumor
necrosis factor, B cell monoclonal antibodies
- current or chronic pulmonary infection (bacterial, fungal, mycobacterial), pneumonia,
or rhinosinusitis within 2 months
- chronic lung disease
- renal insufficiency, defined as serum creatinine >1.6
- active liver disease, including hepatitis C virus infection
- history of splenectomy
- history of antibacterial therapy within 3 months of nasal swab (week 0)
- current alcohol abuse
- chronic heart disease
- diabetes
- current cigarette smoking
We found this trial at
3
sites
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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