Phase 1 trial of a 24-valent Klebsiella capsular polysaccharide vaccine and an eight-valent Pseudomonas O-polysaccharide conjugate vaccine administered simultaneously

Vaccine. 1994 Nov;12(14):1288-94. doi: 10.1016/s0264-410x(94)80054-4.

Abstract

A Klebsiella (K) vaccine consisting of 24 capsular polysaccharide antigens and a Pseudomonas aeruginosa (P) vaccine consisting of eight O-polysaccharide antigens conjugated to P toxin A have been developed to prevent sepsis by means of active or passive immunoprophylaxis. In search for a practical immunization schedule, the two vaccines were injected in opposite arms simultaneously (20 volunteers) or 14 days apart (21 volunteers). The vaccines were similarly well tolerated by both volunteer groups. Geometric mean antibody concentrations and mean fold antibody rises to the 33 vaccine antigens (including toxin A) were similar in the two groups at 2 months, and the decline in antibody measured at 18 months was also similar. Because the two vaccines were safe and similarly immunogenic in the two vaccine groups, they can be administered simultaneously to patients or plasma donors in a practical vaccination schedule.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Controlled Clinical Trial
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Bacterial / biosynthesis
  • Antibodies, Bacterial / blood
  • Bacterial Toxins / immunology
  • Bacterial Vaccines / administration & dosage*
  • Bacterial Vaccines / adverse effects
  • Bacterial Vaccines / immunology*
  • Female
  • Humans
  • Klebsiella / immunology*
  • Male
  • Polysaccharides, Bacterial / immunology*
  • Pseudomonas Vaccines
  • Pseudomonas aeruginosa / immunology*
  • Vaccines, Conjugate / immunology

Substances

  • Antibodies, Bacterial
  • Bacterial Toxins
  • Bacterial Vaccines
  • Polysaccharides, Bacterial
  • Pseudomonas Vaccines
  • Pseudomonas aeruginosa O polysaccharide-toxin A conjugate vaccine
  • Vaccines, Conjugate