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. Lam; A. Upton; R. Budhram; B. D. Kirkpatrick

doi:10.1016/j.vaccine.2010.02.017

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

Bloomberg School of Public Health

Research output: Contribution to journal › Article › peer-review

33 Scopus citations

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 language	English (US)
Pages (from-to)	3602-3608
Number of pages	7
Journal	Vaccine
Volume	28
Issue number	20
DOIs	https://doi.org/10.1016/j.vaccine.2010.02.017
State	Published - Apr 30 2010

Keywords

Oral vaccine
Typhoid
Typhoid vaccine

ASJC Scopus subject areas

Molecular Medicine
General Immunology and Microbiology
General Veterinary
Public Health, Environmental and Occupational Health
Infectious Diseases

Access to Document

10.1016/j.vaccine.2010.02.017

Cite this

Lyon, C. E., Sadigh, K. S., Carmolli, M. P., Harro, C., Sheldon, E., Lindow, J. C., Larsson, C. J., Martinez, T., Feller, A., Ventrone, C. H., Sack, D. A., DeNearing, B., Fingar, A., Pierce, K., Dill, E. A., Schwartz, H. I., Beardsworth, E. E., Kilonzo, B., May, J. P., ... Kirkpatrick, B. D. (2010). 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. Vaccine, 28(20), 3602-3608. https://doi.org/10.1016/j.vaccine.2010.02.017

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 2010, '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', Vaccine, vol. 28, no. 20, pp. 3602-3608. https://doi.org/10.1016/j.vaccine.2010.02.017

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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.",

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AU - Lyon, C. E.

AU - Sadigh, K. S.

AU - Carmolli, M. P.

AU - Harro, C.

AU - Sheldon, E.

AU - Lindow, J. C.

AU - Larsson, C. J.

AU - Martinez, T.

AU - Feller, A.

AU - Ventrone, C. H.

AU - Sack, D. A.

AU - DeNearing, B.

AU - Fingar, A.

AU - Pierce, K.

AU - Dill, E. A.

AU - Schwartz, H. I.

AU - Beardsworth, E. E.

AU - Kilonzo, B.

AU - May, J. P.

AU - Lam, W.

AU - Upton, A.

AU - Budhram, R.

AU - Kirkpatrick, B. D.

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N2 - 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.

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