Immune Response to Pneumococcal Vaccination in Aging HIV Positive Adults
Completed · Early Phase 1
Conditions studied: HIV Lipodystrophy, Aging
In brief
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
Key facts
- Study ID
- NCT03039491
- Run by
- Medical University of South Carolina
- People needed
- 160
- Starts
- 2015-09-01
- Expected to finish
- 2020-03-30
- Last updated by the study team
- 2020-06-16
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Previous immunization with pneumococcal vaccine less than 5 years ago
- pregnancy and absence of contraceptive practice in women of childbearing age and breast feeding
- known anaphylaxis, hypersensitivity to the pneumonia vaccine
- those who received blood products or gammaglobulin in last 3 months
- inability to comprehend or sihn informed consent
- Medications known to affect immune function (chemotherapy, an angiotensin-converting-enzyme (ACE) inhibitors, corticosteroids, anti-TNFalpha agents)
- previous disease/present illness that may affect response to vaccination: previous pneumococcal disease, removal of spleen, auto-immune disease, end stage renal disease (ESRD) or end stage liver disease, cancer)
- significant (3x upper limit of normal) in complete blood count (CBC), chemistries, immunoglobulin levels
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.