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
| Autor: | E. Sheldon, R. Budhram, W. Lam, Catherine J. Larsson, Marya P. Carmolli, A. Upton, B. Kilonzo, Kristen K. Pierce, J. P. May, Janet C. Lindow, Andrea Feller, Caroline E. Lyon, Beth D. Kirkpatrick, Elizabeth A. Dill, E. E. Beardsworth, T. Martinez, Katrin Sadigh, David A. Sack, H. I. Schwartz, Barbara DeNearing, A. Fingar, Cassandra H. Ventrone, Clayton Harro |
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| Rok vydání: | 2009 |
| Předmět: |
Adult
Male Adolescent Placebo-controlled study Placebo Vaccines Attenuated complex mixtures Typhoid fever law.invention Young Adult Randomized controlled trial Double-Blind Method law medicine Humans Typhoid Fever General Veterinary General Immunology and Microbiology business.industry Immunogenicity ELISPOT Typhoid-Paratyphoid Vaccines Public Health Environmental and Occupational Health Middle Aged bacterial infections and mycoses medicine.disease Antibodies Bacterial Immunoglobulin A Vaccination Infectious Diseases Immunoglobulin G Typhoid vaccine Immunology Molecular Medicine Female business |
| Zdroj: | Vaccine. 28(20) |
| ISSN: | 1873-2518 |
| Popis: | M01ZH09, S. Typhi (Ty2Δ aroC Δ 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 × 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 × 10 10 CFU. Efficacy testing of this single-dose oral typhoid vaccine is needed. |
| Databáze: | OpenAIRE |
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