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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 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.

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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

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

FieldValue
Enrollment Target 160 participants
Start Date 2015-09-01
Est. Completion 2020-03-30
Phase Early Phase 1

What the Registry Record Tells You About NCT03039491

The ClinicalTrials.gov registry entry for NCT03039491 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,194-participant average among 262 other Aging trials with a reported enrollment target (93% lower). The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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