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Immune Response to Pneumococcal Vaccination in Aging HIV Positive Adults

NCT03039491 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2020-06-16

No results posted yet for this 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

  • HIV Lipodystrophy
  • Aging

Interventions

BIOLOGICAL

Pneumococcal polysaccharide vaccine 23 valent

This is the pneumococcal vaccine consisting of the capsular polysaccharides of 23 serotypes of Streptococcus pneumoniae

BIOLOGICAL

13 valent conjugated pneumococcal vaccine

This is the pneumococcal vaccine consisting of the capsular polysaccharides of 13 serotypes of Streptococcus pneumoniae conjugated to non-toxic diphtheria carrier protein 197

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Maria A. Julia Westerink, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-01
Primary Completion
2020-03-30
Completion
2020-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03039491 on ClinicalTrials.gov