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NCT02558751 · ClinicalTrials.gov registry record · Early Phase 1
Pneumonia Vaccine in Aging HIV Positive Individuals
A Early Phase 1 study, sponsored by University of Toledo Health Science Campus.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 51
- Enrollment target
NCT02558751: Completed Early Phase 1 study, sponsored by University of Toledo Health Science Campus.
NCT02558751 is a Early Phase 1 study that has completed, run by University of Toledo Health Science Campus. The registered enrollment target is 51 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02558751, a Early Phase 1 study, has completed, sponsored by University of Toledo Health Science Campus.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
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.
Interventions
- BIOLOGICAL 23-valent pneumococcal polysaccharide vaccine
- BIOLOGICAL 13-valent pneumococcal conjugate vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2013-07 |
| Est. Completion | 2015-06 |
| Phase | Early Phase 1 |
What the finished NCT02558751 record still lists
NCT02558751 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which 23-valent pneumococcal polysaccharide vaccine is the first listed.
NCT02558751 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02558751 about?
NCT02558751 is a clinical study titled "Pneumonia Vaccine 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 polysacchari...
What is the current status of trial NCT02558751?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 51 participants. The study started on 2013-07. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02558751?
The interventions under investigation include: 23-valent pneumococcal polysaccharide vaccine (BIOLOGICAL), 13-valent pneumococcal conjugate vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02558751?
This trial is sponsored by University of Toledo Health Science Campus, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02558751's enrollment target sits among peer trials
51 486th of 2000 higher than 1,509 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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