Pneumococcal Infection Clinical Trial
Official title:
Immune Response to Pneumococcal Vaccination in Aging HIV Positive Individuals
The investigators hypothesized that vaccination with either the 23-valent pneumococcal
polysaccharide vaccine (PPV23) alone or the 13-valent pneumococcal conjugate vaccine (PCV
13) followed by PPV23 results in similar antibody levels/functional activity and induce a
similar pneumococcal polysaccharide (PPS)-specific B cell response in HIV-positive
individuals >50 years of age and HIV-negative persons>50 years of age. The investigators
immunized the study group HIV+ persons>50 and controls (HIV negative >50 years) with PCV13
followed by PPV23 and HIV+>50 with PPV23 alone. The investigators examined immune responses
to PPS23F and PPS14 on a quantitative and qualitative level using ELISA and opsonophagocytic
assays (OPA).
To test the hypothesis that the levels of antigen specific B cells identified with PPS were
comparable between the PPV23 and PCV13 vaccine recipients. Pre- and post-immunization
peripheral blood samples were obtained. Extensive B cell phenotype analysis using
fluorescent antibodies was used to characterize PPS-labeled B cells. Specific phenotypes
were correlated with antibody levels and OPA and compared to historic populations immunized
with PPV.
Status | Completed |
Enrollment | 51 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 50 Years to 65 Years |
Eligibility |
Inclusion Criteria: - HIV negative: - never immunized with PCV13 - HIV positive: - need for pneumococcal vaccination per standard of care Exclusion Criteria: - steroid use - other immunosuppressive agents; - pregnancy - incapable of completing consent form |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | The University of Toledo-Health Science Campus | Toledo | Ohio |
Lead Sponsor | Collaborator |
---|---|
University of Toledo Health Science Campus | National Institute on Aging (NIA) |
United States,
Ballet JJ, Sulcebe G, Couderc LJ, Danon F, Rabian C, Lathrop M, Clauvel JP, Seligmann M. Impaired anti-pneumococcal antibody response in patients with AIDS-related persistent generalized lymphadenopathy. Clin Exp Immunol. 1987 Jun;68(3):479-87. — View Citation
Janoff EN, Douglas JM Jr, Gabriel M, Blaser MJ, Davidson AJ, Cohn DL, Judson FN. Class-specific antibody response to pneumococcal capsular polysaccharides in men infected with human immunodeficiency virus type 1. J Infect Dis. 1988 Nov;158(5):983-90. — View Citation
Klein RS, Selwyn PA, Maude D, Pollard C, Freeman K, Schiffman G. Response to pneumococcal vaccine among asymptomatic heterosexual partners of persons with AIDS and intravenous drug users infected with human immunodeficiency virus. J Infect Dis. 1989 Nov;1 — View Citation
Kroon FP, van Dissel JT, Ravensbergen E, Nibbering PH, van Furth R. Enhanced antibody response to pneumococcal polysaccharide vaccine after prior immunization with conjugate pneumococcal vaccine in HIV-infected adults. Vaccine. 2000 Nov 22;19(7-8):886-94. — View Citation
Rodriguez-Barradas MC, Musher DM, Lahart C, Lacke C, Groover J, Watson D, Baughn R, Cate T, Crofoot G. Antibody to capsular polysaccharides of Streptococcus pneumoniae after vaccination of human immunodeficiency virus-infected subjects with 23-valent pneu — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Antibody response measured by ELISA (ug/ml) | Change in ug/ml from day 0 to day 30 | No | |
Primary | Opsonophagocytic antibody activity measured by opsonophagocytic assay (OPA titer) | Change in OPA titer from day 0 to day 30 | No | |
Primary | Antibody response measured by ELISA (ug/ml) | Change in ug/ml from day 0 to day 90 | No | |
Primary | Opsonophagocytic antibody activity measured by opsonophagocytic assay (OPA titer) | Change in OPA titer from day 0 to day 90 | No | |
Secondary | B cell phenotype of PPS-specific B cells expressing CD27+IgM+: flowcytometry (%) | Change from day 0 to day 7 in % | No | |
Secondary | Serum C-reactive protein (ng/ml) | day 0 | No | |
Secondary | Flow cytometry : percentage cells expressing BAFF-R on surface (%) | Change from day 0 to day 7 | No | |
Secondary | Flow cytometry : percentage cells expressing BAFF-R on surface (%) | Change from day 56 to day 63 | No | |
Secondary | B cell phenotype of PPS-specific B cells expressing CD27IgM: flowcytometry (%) | Change from day 56 to day 63 (%) | No | |
Secondary | Serum IL-6 level (pg/ml) | Day 0 | No | |
Secondary | Serum sCD27 (U/ml) | Day 0 | No | |
Secondary | Serum sCD30 (U/ml) | Day 0 | No | |
Secondary | Serum BAFF concentration (pg/ml) | Day 0 | No | |
Secondary | Serum TACI concentration (pg/ml) | Day 0 | No | |
Secondary | Serum BCMA concentration (pg/ml) | Day 0 | No | |
Secondary | Flow cytometry : percentage cells expressing CD40 on surface (%) | Change from day 0 to day 7 (%) | No | |
Secondary | Flow cytometry : percentage cells expressing CD40 on surface (%) | Change from day 56 to day 63 (%) | No | |
Secondary | Flow cytometry : percentage cells expressing CD21 on surface (%) | Change from day 0 to day 7 (%) | No | |
Secondary | Flow cytometry : percentage cells expressing CD21 on surface (%) | Change from day 56 to day 63 (%) | No | |
Secondary | Flow cytometry : percentage cells expressing TACI on surface (%) | Change from day 0 to day 7 (%) | No | |
Secondary | Flow cytometry : percentage cells expressing TACI on surface (%) | Change from day 56 to day 63 (%) | No |
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