Outpatient studies of the safety and immunogenicity of an auxotrophic Escherichia coli K-12-Shigella flexneri 2a hybrid vaccine candidate, EcSf2a-2

David N. Taylor, Douglas F. Phillip, Michael Zapor, Andrew Trofa, Lillian Van de Verg, Antoinette Hartman, Natalie Bendiuk, John W. Newland, Samuel B. Formal, Jerald C. Sadoff, Thomas L. Hale

Research output: Contribution to journalArticlepeer-review

Abstract

A phase II study was conducted in 244 volunteers at Fort Ord, CA, to determine the safety and immunogenicity of EcSf2a-2, a live, oral Shigella vaccine constructed by transfer of genes from Shigella flexneri to Escherichia coli K-12. In this placebo-controlled study, four doses of vaccine ranging from 2.3 to 9.0 × 108 colony-forming units were given on days 0, 3, 14 and 17. Vaccine shedding occurred from 1 to 3 days after each dose. The vaccine was well tolerated at every dose tested. Significant levels of IgA, IgG or IgM antibody-secreting cells (ASC) recognizing S. flexneri 2a lipopolysaccharide (LPS) were found in 94% of a volunteer subset tested 7 days after the first dose of EcSf2a-2. Seven days after the third dose, ASC were detected less often (57%), and were mainly IgA. Significant rises in serum antibody to LPS were detected in 37% of vaccine recipients.

Original languageEnglish (US)
Pages (from-to)565-568
Number of pages4
JournalVaccine
Volume12
Issue number6
DOIs
StatePublished - May 1994

Keywords

  • ELISA
  • Escherichia coli-Shigella hybrid vaccine
  • antibody-secreting cells
  • mucosal immunization
  • phase II study

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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