The purpose of this project is to conduct a clinical evaluation of the safety, immunogenicity and efficacy in children in an endemic area of investigational vaccines designed to prevent shigellosis. The contractor is to perform Phase 2 study (safety and immunogenicity) of Shigella flexneri type 2a EPA and S. sonnei EPA conjugate vaccines in children aged 4 to 6 years old. Each vaccine shall be injected into 50 children, ages 4 to 6 years old. A total of 100 children shall be vaccinated. One hundred children, who have received the Hepatitis B vaccine shall serve as controls for this study. This project has been approved by the NIH (Protocol Number OH94-CH-NO94) and FDA (BB-IND-4331-S. Sonnei and BB-IND- 3866-S. flexneri).
| Chowers, Yehuda; Kirschner, Joachim; Keller, Nathan et al. (2007) O-specific [corrected] polysaccharide conjugate vaccine-induced [corrected] antibodies prevent invasion of Shigella into Caco-2 cells and may be curative. Proc Natl Acad Sci U S A 104:2396-401 |
| Passwell, Justen H; Ashkenazi, Shai; Harlev, Efrat et al. (2003) Safety and immunogenicity of Shigella sonnei-CRM9 and Shigella flexneri type 2a-rEPAsucc conjugate vaccines in one- to four-year-old children. Pediatr Infect Dis J 22:701-6 |
