title: 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.
abstract: 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.
authors.affiliation: The University of Vermont College of Medicine, Burlington, VT 05405, USA.
authors.forename: C E
authors.initials: CE
authors.lastname: Lyon
authors.forename: K S
authors.initials: KS
authors.lastname: Sadigh
authors.forename: M P
authors.initials: MP
authors.lastname: Carmolli
authors.forename: C
authors.initials: C
authors.lastname: Harro
authors.forename: E
authors.initials: E
authors.lastname: Sheldon
authors.forename: J C
authors.initials: JC
authors.lastname: Lindow
authors.forename: C J
authors.initials: CJ
authors.lastname: Larsson
authors.forename: T
authors.initials: T
authors.lastname: Martinez
authors.forename: A
authors.initials: A
authors.lastname: Feller
authors.forename: C H
authors.initials: CH
authors.lastname: Ventrone
authors.forename: D A
authors.initials: DA
authors.lastname: Sack
authors.forename: B
authors.initials: B
authors.lastname: DeNearing
authors.forename: A
authors.initials: A
authors.lastname: Fingar
authors.forename: K
authors.initials: K
authors.lastname: Pierce
authors.forename: E A
authors.initials: EA
authors.lastname: Dill
authors.forename: H I
authors.initials: HI
authors.lastname: Schwartz
authors.forename: E E
authors.initials: EE
authors.lastname: Beardsworth
authors.forename: B
authors.initials: B
authors.lastname: Kilonzo
authors.forename: J P
authors.initials: JP
authors.lastname: May
authors.forename: W
authors.initials: W
authors.lastname: Lam
authors.forename: A
authors.initials: A
authors.lastname: Upton
authors.forename: R
authors.initials: R
authors.lastname: Budhram
authors.forename: B D
authors.initials: BD
authors.lastname: Kirkpatrick
mesh_terms: D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D007074:Immunoglobulin G / Q000097:blood; D008297:Male; D008875:Middle Aged; D014435:Typhoid Fever / Q000517:prevention & control; D014436:Typhoid-Paratyphoid Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000276:immunology; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D014436:Typhoid-Paratyphoid Vaccines; D014613:Vaccines, Attenuated; C503988:typhoid vaccine M01ZH09