Pneumonia Vaccine in Aging HIV Positive Individuals
Completed · Early Phase 1
Conditions studied: Pneumococcal Infection
In brief
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.
Key facts
- Study ID
- NCT02558751
- Run by
- University of Toledo Health Science Campus
- People needed
- 51
- Starts
- 2013-07-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2015-09-24
Who can join
Age: 50 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- HIV negative:
- never immunized with PCV13
- HIV positive:
- need for pneumococcal vaccination per standard of care
You may not qualify if…
- steroid use
- other immunosuppressive agents;
- pregnancy
- incapable of completing consent form
Where it is running
- The University of Toledo-Health Science Campus — Toledo, Ohio, United States
Full record on ClinicalTrials.gov
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