Dennis J Kopecko
Affiliation: Food and Drug Administration
- Molecular cloning and characterization of genes for Shigella sonnei form I O polysaccharide: proposed biosynthetic pathway and stable expression in a live salmonella vaccine vectorDe-Qi Xu
Oral Infection and Immunity Branch, National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, Maryland 20892, USA
Infect Immun 70:4414-23. 2002..sonnei challenge, thereby supporting the promise of live, oral vaccines for the prevention of shigellosis...
- Core-linked LPS expression of Shigella dysenteriae serotype 1 O-antigen in live Salmonella Typhi vaccine vector Ty21a: preclinical evidence of immunogenicity and protectionDe Qi Xu
Laboratory of Enteric and Sexually Transmitted Diseases, FDA CBER, Bethesda, MD 20892, United States
Vaccine 25:6167-75. 2007..These data further demonstrate the utility of S. Typhi Ty21a as a live, bacterial vaccine delivery system for heterologous O-antigens, supporting the promise of a bifunctional oral vaccine for prevention of shigellosis and typhoid fever...
- Considerations in the development of live biotherapeutic products for clinical useJennifer J Ross
Division of Vaccines and Related Products Applications, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration PHS, Rockville, MD, USA
Curr Issues Mol Biol 10:13-6. 2008..S. for a specific clinical use. Product information is an important component of an IND to support a proposed clinical study...
- Anthrax protective antigen delivered by Salmonella enterica serovar Typhi Ty21a protects mice from a lethal anthrax spore challengeManuel Osorio
Division of Bacterial, Parasitic and Allergenic Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland 20892, USA
Infect Immun 77:1475-82. 2009..anthracis 7702. The ultimate goal is a temperature-stable, safe, oral human vaccine against anthrax infection that can be self-administered in a few doses over a short period of time...
- Bacterial delivery of siRNAs: a new approach to solid tumor therapyDe Qi Xu
Laboratory of Enteric and Sexually Transmitted Diseases, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD, USA
Methods Mol Biol 487:161-87. 2009..This chapter describes the use of attenuated bacteria as tumor-targeting delivery systems for cancer therapy...
- Campylobacter jejuni-mediated induction of CC and CXC chemokines and chemokine receptors in human dendritic cellsLan Hu
Laboratory of Enteric and Sexually Transmitted Diseases, Center for Biologics Evaluation and Research, U S Food and Drug Administration, Bethesda, Maryland, USA
Infect Immun 80:2929-39. 2012..These results suggest that DCs play a significant role in the initiation and modulation of the inflammatory response by enlisting monocytes, neutrophils, and T lymphocytes during human intestinal infection with Campylobacter...
- Genetic stability of vaccine strain Salmonella Typhi Ty21a over 25 yearsDennis J Kopecko
Laboratory of Enteric and Sexually Transmitted Diseases, Center for Biologics Evaluation and Research, Food and Drug Administration, 29 Lincoln Drive, NIH Campus, Bldg 29 420, HFM440, Bethesda, MD 20892, USA
Int J Med Microbiol 299:233-46. 2009..Finally, we have confirmed the correlation of these genetic mutations with the expected phenotypic attenuations for the seed lots used in vaccine manufacture over 25 years...
- Ca2+ release from host intracellular stores and related signal transduction during Campylobacter jejuni 81-176 internalization into human intestinal cellsLan Hu
Laboratory of Enteric and Sexually Transmitted Diseases, FDA-Center for Biologics Evaluation and Research, 29 Lincoln Drive, Bldg 29/420 HFM440, Bethesda, MD 20892, USA
Microbiology 151:3097-105. 2005..jejuni invasion. These results demonstrate that C. jejuni induces the mobilization of Ca(2+) from host intracellular stores, which is an essential step in the invasion of intestinal cells by this pathogen...
- Effects of plasmid-based Stat3-specific short hairpin RNA and GRIM-19 on PC-3M tumor cell growthLing Zhang
Prostate Diseases Prevention and Treatment Research Center and Department of Pathophysiology, School of Basic Medicine, Jilin University, Changchun, PR China
Clin Cancer Res 14:559-68. 2008..To enhance the therapeutic efficacy of Stat3-specific shRNA, we applied a combination treatment involving gene associated with retinoid-IFN-induced mortality 19 (GRIM-19), another inhibitor of STAT3, along with shRNA...
- Activation of hilA expression at low pH requires the signal sensor CpxA, but not the cognate response regulator CpxR, in Salmonella enterica serovar TyphimuriumShu-Ichi Nakayama
Department of Bacteriology, National Institute of Infectious Diseases, Toyama, 1-23-1, Shinjuku-ku, Tokyo 162-8640, Japan
Microbiology 149:2809-17. 2003..Further, the results show that this CpxA-mediated activation does not require its putative cognate response regulator, CpxR. This suggests that CpxA may interact with regulator(s) other than CpxR to achieve activation at low pH...