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Study Design

Type
Clinical Trial
Population
Healthy adult volunteers
Methods
Controlled experimental study

Abstract

Healthy adult volunteers were vaccinated on day 0 and 28 and at 15 months with a Pseudomonas aeruginosa immunotype 5 O polysaccharide-toxin A conjugate vaccine. Immunization resulted in mild, transient local reactions in less than 20% of the subjects. Maximal immunoglobulin G (IgG) antibody titers to both toxin A and lipopolysaccharide (LPS) as determined by enzyme-linked immunosorbent assay were seen at day 42, at which time 50% of the vaccinees showed a fourfold or greater rise in toxin A-neutralizing titers. By 15 months postvaccination, both antitoxin A and anti-LPS IgG antibodies had markedly declined. A booster dose of vaccine administered at 15 months evoked a vigorous anti-toxin A IgG antibody response with 100% of the volunteers showing a fourfold or greater rise in neutralizing antibody titer compared with preimmunization levels. In contrast, there was no significant elevation of anti-LPS IgG antibody levels. At 24 months postimmunization, only anti-toxin A antibody levels were significantly higher than preimmunization levels.

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