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NCT03039491 · ClinicalTrials.gov registry record · Early Phase 1
Immune Response to Pneumococcal Vaccination in Aging HIV Positive Adults
A Early Phase 1 study of Aging and HIV Lipodystrophy, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 160
- Enrollment target
- 1
- Study location
NCT03039491: Completed Early Phase 1 study of Aging and HIV Lipodystrophy, sponsored by Medical University of South Carolina.
NCT03039491 is a Early Phase 1 study of Aging and HIV Lipodystrophy that has completed, run by Medical University of South Carolina. The registered enrollment target is 160 participants, below the 2,194-participant average among 262 other Aging trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03039491, a Early Phase 1 study of Aging and HIV Lipodystrophy, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 160 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators hypothesized that pneumococcal vaccination with either the 23-valent pneumococcal polysaccharide vaccine PPV-23 (Pneumovax-23) alone or the 13-valent pneumococcal conjugate vaccine PCV-13 (Prevnar-13) followed by PPV-23 results in a similar antibody levels/functional antibody activity and induce similar pneumococcal polysaccharide (PPS)-specific B cell response in HIV positive individuals \> 50 years of age, HIV positive individuals 21-40 years of age as compared to HIV negative \> 50 years of age. The investigators immunized the study groups HIV+ persons \>50, HIV+ persons 21-40 and controls (HIV negative) with PCV 13 followed by PPV23 and HIV\>50 with PPV alone and examined immune responses to polysaccharide (PPS) 23 (F),14, 3, 7 (F) and 19 (A) using polysaccharide specific ELISA and opsonophagocytic assays (OPA). 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 populations immunized with PPV
Primary Outcome
Measure antibody response by ELISA (ug/mL)
Conditions Studied
Interventions
- BIOLOGICAL Pneumococcal polysaccharide vaccine 23 valent
- BIOLOGICAL 13 valent conjugated pneumococcal vaccine
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2015-09-01 |
| Est. Completion | 2020-03-30 |
| Phase | Early Phase 1 |
What the finished NCT03039491 record still lists
NCT03039491 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 2,194-participant average among 262 other Aging trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Aging appearing as the primary indexed condition, and to 2 interventions - of which Pneumococcal polysaccharide vaccine 23 valent is the first listed.
NCT03039491 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT03039491 about?
NCT03039491 is a clinical study titled "Immune Response to Pneumococcal Vaccination in Aging HIV Positive Adults". The investigators hypothesized that pneumococcal vaccination with either the 23-valent pneumococcal polysaccharide vaccine PPV-23 (Pneumovax-23) alone or the 13-valent pneumococcal conjugate vaccine PCV-13 (Prevnar-13) followed by PPV-23 results in a similar antibody levels/functional antibody activ...
What is the current status of trial NCT03039491?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 160 participants. The study started on 2015-09-01. Estimated completion is 2020-03-30.
What conditions does trial NCT03039491 study?
This clinical trial studies the following conditions: Aging, HIV Lipodystrophy.
What interventions are being tested in trial NCT03039491?
The interventions under investigation include: Pneumococcal polysaccharide vaccine 23 valent (BIOLOGICAL), 13 valent conjugated pneumococcal vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03039491?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03039491 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03039491's enrollment target sits among peer trials
160 58th of 262 higher than 204 of 262 other Aging trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aging 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.
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