In a randomized, double-blinded, placebo-controlled trial, the single oral dose typhoid vaccine, M01ZH09, is safe and immunogenic at doses up to 1.7 × 1010 colony-forming units

C. E. Lyon, K. S. Sadigh, M. P. Carmolli, C. Harro, E. Sheldon, J. C. Lindow, C. J. Larsson, T. Martinez, A. Feller, C. H. Ventrone, D. A. Sack, B. DeNearing, A. Fingar, K. Pierce, E. A. Dill, H. I. Schwartz, E. E. Beardsworth, B. Kilonzo, J. P. May, W. LamA. Upton, R. Budhram, B. D. Kirkpatrick

Research output: Contribution to journalArticlepeer-review

Abstract

M01ZH09, S. Typhi (Ty2ΔaroCΔssaV) ZH9, is a single oral dose typhoid vaccine with independently attenuating deletions. A phase II randomized, double-blind, placebo-controlled, dose-escalating trial evaluated the safety and immunogenicity of M01ZH09 to 1.7 × 1010 colony-forming units (CFU). 187 Healthy adults received vaccine or placebo in four cohorts. Serologic responses and IgA ELISPOT were measured. At all doses, the vaccine was well tolerated and without bacteremias. One subject had a transient low-grade fever. 62.2-86.1% of subjects seroconverted S. Typhi-specific LPS IgG and 83.3-97.4% IgA; 92.1% had a positive S. Typhi LPS ELISPOT. M01ZH09 is safe and immunogenic up to 1.7 × 1010 CFU. Efficacy testing of this single-dose oral typhoid vaccine is needed.

Original languageEnglish (US)
Pages (from-to)3602-3608
Number of pages7
JournalVaccine
Volume28
Issue number20
DOIs
StatePublished - Apr 30 2010

Keywords

  • Oral vaccine
  • Typhoid
  • Typhoid vaccine

ASJC Scopus subject areas

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

Fingerprint Dive into the research topics of 'In a randomized, double-blinded, placebo-controlled trial, the single oral dose typhoid vaccine, M01ZH09, is safe and immunogenic at doses up to 1.7 × 10<sup>10</sup> colony-forming units'. Together they form a unique fingerprint.

Cite this