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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI108479 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV-seronegative | Experimental | HIV-seronegative subjects will receive Prevnar (PCV-13) at week 0. |
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| HIV-infected | Experimental | HIV-infected subjects will receive Prevnar (PCV-13) at week 0, and Pneumovax (PPSV-23) at week 8 per Advisory Committee on Immunization Practices (ACIP) guidelines. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCV-13 | Biological |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| B and T cell subsets | Activation and subset distribution of B and T cell subsets and cluster of differentiation positive (CD4+) T cells and T follicular helper (TFH) cells on days 0 and 7 after stimulation | Weeks -12, 0, 1, 8, 9, 16 |
| Total IgG, IgM and IgA | Total immunoglobulin G (IgG), immunoglobulin M (IgM) and immunoglobulin A (IgA) produced from culture of peripheral blood mononuclear cells (PBMC) stimulated in triplicate with B cell stimuli on day 7 by enzyme-linked immunosorbent assay (ELISA) | Weeks -12, 0, 1, 8, 9, 16 |
| Antibody-secreting cells | Total IgG, IgM and IgA antibody-secreting cells (ASC) enumerated by enzyme-linked immunospot (ELISPOT) on day 0 and day 7 | Weeks 0, 1, 8, 9 |
| AID and BCL-6 production | RNA extraction for activation-induced cytidine deaminase (AID) and B cell lymphoma protein 6 (BCL6) expression and mutation from stimulated B cells | Weeks -12, 0, 1, 8, 9, 16 |
| Measure | Description | Time Frame |
|---|---|---|
| S.pneumoniae colonization and nasopharyngeal microbiome | Prevalence of nasopharyngeal S. pneumoniae determined by quantitative polymerase chain reaction(Q-PCR) and 16S ribosomal RNA (rRNA) sequencing, related microbiota (commensal bacteria) and correlation between colonization and levels of pneumococcal capsule-specific IgG | Weeks -12, 0, 8, 16 |
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Inclusion Criteria:
For HIV-infected subjects:
For HIV-seronegative controls:
Exclusion Criteria:
For all subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Edward N Janoff, MD | University of Colorado-Denver, Denver VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado-Denver | Aurora | Colorado | 80045 | United States | ||
| Denver Health and Hospitals |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 16, 2022 | |
| Reset | Jun 15, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 16, 2022 | Jun 15, 2022 |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| PPSV-23 |
| Biological |
|
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| S.pneumoniae urine antigen positivity | S. pneumoniae urine antigen positivity in relation to colonization | Week -12 |
| Denver |
| Colorado |
| 80204 |
| United States |
| Denver VA Medical Center | Denver | Colorado | 80220 | United States |
| D007239 | Infections |
| D045424 |
| Complex Mixtures |
| D017778 | Vaccines, Combined |