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 x 10(10)
colony-forming units.
Author(s): Lyon CE, Sadigh KS, Carmolli MP, Harro C, Sheldon E, Lindow JC, Larsson CJ,
Martinez T, Feller A, Ventrone CH, Sack DA, DeNearing B, Fingar A, Pierce K, Dill
EA, Schwartz HI, Beardsworth EE, Kilonzo B, May JP, Lam W, Upton A, Budhram R,
Kirkpatrick BD.
Affiliation(s): The University of Vermont College of Medicine, Burlington, VT 05405, USA.
Publication date & source: 2010, Vaccine. , 28(20):3602-8
M01ZH09, S. Typhi (Ty2 Delta aroC Delta ssaV) 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 x 10(10) 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 x 10(10)CFU.
Efficacy testing of this single-dose oral typhoid vaccine is needed.
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