Preliminary assessment of the safety and immunogenicity of a new CTXPhi-negative, hemagglutinin/protease-defective El Tor strain as a cholera vaccine candidate.

Academic Article

Abstract

  • Vibrio cholerae 638 (El Tor, Ogawa), a new CTXPhi-negative hemagglutinin/protease-defective strain that is a cholera vaccine candidate, was examined for safety and immunogenicity in healthy adult volunteers. In a double-blind placebo-controlled study, no significant adverse reactions were observed in volunteers ingesting strain 638. Four volunteers of 42 who ingested strain 638 and 1 of 14 who received placebo experienced loose stools. The strain strongly colonized the human small bowel, as evidenced by its isolation from the stools of 37 of 42 volunteers. V. cholerae 638, at doses ranging from 4 x 10(7) to 2 x 10(9) vibrios, elicited significant serum vibriocidal antibody and anti-Ogawa immunoglobulin A antibody secreting cell responses.
  • Keywords

  • Adult, Animals, Bacteriophages, Cholera Toxin, Cholera Vaccines, Humans, Male, Metalloendopeptidases, Mutagenesis, Rabbits, Vaccines, Synthetic, Vibrio cholerae
  • Author List

  • Benítez JA; García L; Silva A; García H; Fando R; Cedré B; Pérez A; Campos J; Rodríguez BL; Pérez JL
  • Start Page

  • 539
  • End Page

  • 545
  • Volume

  • 67
  • Issue

  • 2