The Clinical Core is to provide centralized clinical expertise for conducting research in human subjects to facilitate and support the ultimate goals of the Center, which is to optimize mucosal immunity via targeting dendritic cell subsets. This Core will operate according to the highest standards of good clinical practice (GCP). Our studies in human subjects will include: a) healthy normal volunteers who will be immunized with licensed influenza vaccines;and b) individuals with naturally-acquired influenza infection. We have initiated a careful and detailed process for testing and evaluation of the different vaccine candidates developed by the Center using a number of in vitro assays and in vivo models, including both Humouse and the nonhuman primates. It is essential that we analyze side by side the immune responses induced by the most promising vaccine candidates with the immune responses generated after immunization with licensed influenza vaccines and naturally acquired infection. This Clinical Core will take advantage of the established infrastructure and successful collaboration initiated during the previous U19 Center award between the investigators at BUR and the infectious diseases clinical investigators at UT Southwestern Medical Center. Our studies will include three aims:
AIM 1. To obtain sequential clinical samples including both nasal wash and blood specimens from a group of healthy adult volunteers immunized with both live attenuated (LAIV) and inactivated influenza (TIV) vaccines.
AIM 2. To obtain large numbers of immune cells via cell apheresis to perform detailed analysis of immune responses in a small number of healthy volunteers immunized with' LAIV and TIV.
AIM 3. To obtain sequential clinical samples (nasal wash and blood) to assess immune responses in previously healthy adults (age-matched with volunteers) who develop natural influenza infection. By consolidating all proposed clinical studies in one unified structure, the Clinical Core will provide high-quality clinical samples for the different analyses and immune studies proposed across the projects in the Center facilitating the work of the Center investigators,and providing synergy and integration. This infrastructure will optimize the use of samples and resources in an efficient and cost-effective manner.

Public Health Relevance

The Clinical Core consolidates all of the clinical studies for the Center. It will collect clinical specimens (nasal washes, blood, and apheresis) from volunteers who either are immunized with current influenza vaccines or who have contracted influenza naturally. These specimens will be provided to Center investigators.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Program--Cooperative Agreements (U19)
Project #
5U19AI057234-10
Application #
8464006
Study Section
Special Emphasis Panel (ZAI1-KS-I)
Project Start
Project End
Budget Start
2013-05-01
Budget End
2014-04-30
Support Year
10
Fiscal Year
2013
Total Cost
$205,569
Indirect Cost
$59,284
Name
Baylor Research Institute
Department
Type
DUNS #
145745022
City
Dallas
State
TX
Country
United States
Zip Code
75204
Schmitt, Nathalie; Liu, Yang; Bentebibel, Salah-Eddine et al. (2016) Molecular Mechanisms Regulating T Helper 1 versus T Follicular Helper Cell Differentiation in Humans. Cell Rep 16:1082-95
Salabert, Nina; Todorova, Biliana; Martinon, Frédéric et al. (2016) Intradermal injection of an anti-Langerin-HIVGag fusion vaccine targets epidermal Langerhans cells in nonhuman primates and can be tracked in vivo. Eur J Immunol 46:689-700
Kovats, S; Turner, S; Simmons, A et al. (2016) West Nile virus-infected human dendritic cells fail to fully activate invariant natural killer T cells. Clin Exp Immunol 186:214-226
Blohmke, Christoph J; Darton, Thomas C; Jones, Claire et al. (2016) Interferon-driven alterations of the host's amino acid metabolism in the pathogenesis of typhoid fever. J Exp Med 213:1061-77
Yin, Wenjie; Gorvel, Laurent; Zurawski, Sandra et al. (2016) Functional Specialty of CD40 and Dendritic Cell Surface Lectins for Exogenous Antigen Presentation to CD8(+) and CD4(+) T Cells. EBioMedicine 5:46-58
Ueno, Hideki; Banchereau, Jacques; Vinuesa, Carola G (2015) Pathophysiology of T follicular helper cells in humans and mice. Nat Immunol 16:142-52
Schmitt, Nathalie; Ueno, Hideki (2015) Regulation of human helper T cell subset differentiation by cytokines. Curr Opin Immunol 34:130-6
Joo, HyeMee; Upchurch, Katherine; Zhang, Wei et al. (2015) Opposing Roles of Dectin-1 Expressed on Human Plasmacytoid Dendritic Cells and Myeloid Dendritic Cells in Th2 Polarization. J Immunol 195:1723-31
Akinbobuyi, Babatope; Byrd, Matthew R; Chang, Charles A et al. (2015) Facile syntheses of functionalized toll-like receptor 7 agonists. Tetrahedron Lett 56:458-460
Trobaugh, Derek; Green, Sharone (2015) Of Mice and Men: Protective and Pathogenic Immune Responses to West Nile virus Infection. Curr Trop Med Rep 2:41-48

Showing the most recent 10 out of 120 publications