Safety and immunogenicity of CVD 1208S, a live, oral DeltaguaBA Deltasen Deltaset Shigella flexneri 2a vaccine grown on animal-free media.

@article{Kotloff2007SafetyAI,
  title={Safety and immunogenicity of CVD 1208S, a live, oral DeltaguaBA Deltasen Deltaset Shigella flexneri 2a vaccine grown on animal-free media.},
  author={Karen L. Kotloff and Jakub K. Simon and Marcela F Pasetti and Marcelo B. Sztein and Stacey L Wooden and Sofie Livio and James P Nataro and William C Blackwelder and Eileen M. Barry and Wendy L. Picking and Myron M. Levine},
  journal={Human vaccines},
  year={2007},
  volume={3 6},
  pages={268-75}
}
A previous Phase 1 trial demonstrated that Shigella flexneri 2a deleted in guaBA, sen and set (strain CVD 1208) is well-tolerated and immunogenic after a single oral dose of 10(8) or 10(9) CFU. To facilitate further clinical development, the strain was reconstructed using animal-free media to conform to regulatory guidelines, and designated CVD1208S. Healthy inpatient volunteers were randomized (double-blind) to receive a single oral dose of either CVD 1208S (10(8) [n = 7] or 10(9) [n = 7] CFU… CONTINUE READING

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