The objective of this contract is to perform testing of vaccine preparations as required prior to initial clinical evaluation. This includes testing candidate vaccine products for safety and immunogenicity (both cellular and humoral) in small animals and, if appropriate, in non-human primates. For clinical grade materials the manufacturer must perform all required vaccine lot characterization tests. The contractor must also work together with other contractors performing manufacturing of the vaccine product or producing FDA-required documentation in support of an IND.
| Whiteside, Sarah K; Snook, Jeremy P; Ma, Ying et al. (2018) IL-10 Deficiency Reveals a Role for TLR2-Dependent Bystander Activation of T Cells in Lyme Arthritis. J Immunol 200:1457-1470 |
| Chiaro, Tyson R; Soto, Ray; Zac Stephens, W et al. (2017) A member of the gut mycobiota modulates host purine metabolism exacerbating colitis in mice. Sci Transl Med 9: |
| Kubinak, Jason L; Petersen, Charisse; Stephens, W Zac et al. (2015) MyD88 signaling in T cells directs IgA-mediated control of the microbiota to promote health. Cell Host Microbe 17:153-63 |
| Kubinak, Jason L; Stephens, W Zac; Soto, Ray et al. (2015) MHC variation sculpts individualized microbial communities that control susceptibility to enteric infection. Nat Commun 6:8642 |
| Petersen, Charisse; Round, June L (2014) Defining dysbiosis and its influence on host immunity and disease. Cell Microbiol 16:1024-33 |
