Safety, pharmacokinetics, and functional activity of human anti-Pseudomonas aeruginosa monoclonal antibodies in septic and nonseptic patients

J Infect Dis. 1991 Oct;164(4):803-6. doi: 10.1093/infdis/164.4.803.

Abstract

A mixture of five IgM human monoclonal antibodies (MAbs) against lipopolysaccharide antigens of Pseudomonas aeruginosa, plus a human IgG1 MAb against exotoxin A, were studied in 12 noninfected patients and 8 patients with P. aeruginosa bacteremia or pneumonia (or both). The preparation was well tolerated over a dose range of 0.3-1.2 ml/kg (0.75-3.0 mg/kg IgM protein). After a single infusion of 1.2 ml/kg (3.0 mg/kg IgM protein), serum antibody titers were boosted into therapeutic range, with serum half-lives ranging from 34 to 99 h. Also, opsonophagocytic activity in serum rose more than 1 log10 for all but one antibody. In no patient was an immunologic response against the MAb preparation detected.

MeSH terms

  • Adult
  • Aged
  • Antibodies, Bacterial / blood
  • Antibodies, Bacterial / pharmacokinetics
  • Antibodies, Bacterial / therapeutic use
  • Antibodies, Monoclonal / blood
  • Antibodies, Monoclonal / pharmacokinetics
  • Antibodies, Monoclonal / therapeutic use*
  • Dose-Response Relationship, Immunologic
  • Drug Tolerance
  • Female
  • Half-Life
  • Humans
  • Male
  • Middle Aged
  • Opsonin Proteins
  • Phagocytosis
  • Pneumonia / therapy*
  • Pseudomonas Infections / therapy*
  • Pseudomonas aeruginosa / immunology*
  • Sepsis / therapy*

Substances

  • Antibodies, Bacterial
  • Antibodies, Monoclonal
  • Opsonin Proteins