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Principal Investigator: Daniel F. Hoft
Organization: SAINT LOUIS UNIVERSITY
Fiscal Year: 2024
Award: $1,189,190
Funding agency: National Institute of Allergy and Infectious Diseases
Saint Louis University (SLU) seeks to expand its service to the Vaccine and Treatment Evaluation Unit
(VTEU) network providing resources and expertise to help the network achieve its objectives of evaluating
vaccines, preventive biologics, therapeutics and diagnostics for infectious diseases. Dr. Daniel Hoft, SLU VTEU
PI, also serves as Co-PI for a VTEU Leadership Group (LG) application supported by all current VTEUs;
however, regardless of who leads the LG, SLU will provide full support to promote outstanding VTEU research.
Outstanding infrastructure for phase I-IV vaccine & therapeutic trials against priority pathogens: SLU has served
as a VTEU for 29 years, conducted hundreds of phase I-IV trials in healthy and special populations of all ages,
and can provide unique knowledge and extensive infrastructure to support VTEU network goals.
Diverse knowledge scientific skills for trial design priority areas: SLU investigators include experts in vaccinology,
immunology, seasonal and pandemic influenza, tuberculosis, biodefense, urgent/emergent pandemic trials,
liver/enteric diseases, sexually transmitted infections, malaria/neglected tropical diseases, epidemiology and
arboviral diseases. We also provide state-of-the art multi-platform omics core expertise.
Urgent national preparedness trials: SLU has led urgent trials of vaccines against potential bioweapons
(smallpox, anthrax, plague and tularemia), and emergent diseases (2009 H1N1 pandemic flu, avian H5 and H7
flu and Zika/Yellow Fever). In addition to streamlined institutional review and contracting, SLU can contribute
containment facilities for select agent work and inpatient human challenge.
Controlled Human Infection Models: SLU has developed the capacity for human challenge models to study
influenza, parainfluenza, vaccinia, salmonella and tuberculosis immunity. We provide a 23-bed airborne
containment facility for challenge studies with wild type GMP influenza strains, and have developed an active
collaboration with SGS to standardize challenge protocols and obtain influenza challenge strains.
Expertise in First-in-Human, investigator-initiated and pharmacokinetic/pharmacodynamic studies: SLU has
completed dozens of first-in-human and investigator-initiated trials of vaccines against influenza, tuberculosis,
HCV, enteric pathogens, potential bioweapons and emerging flaviviruses. Experimental biology studies of
mucosal and systemic immunity with human samples of blood, tissue and mucosal samples have identified
biomarkers and targets for iterative influenza and tuberculosis vaccine development.
Sexually transmitted infection (STI) expertise: SLU's 10 years in the HIV Vaccine Trials Network provided SLU
with expertise in STI. SLU also led a 44-site herpes vaccine efficacy trial (Herpevac), and two of the highest
enrolling Herpevac sites have agreed to serve as Protocol-Specific Sites to expand our STI expertise. SLU ID
follows ~450 HIV patients and closely collaborates with several molecular virologists.
SLU looks forward to providing its expertise and capacities to meet the new ID challenges of the future.
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Immunology><Mucosa><Mucosal Tissue><Mucous Membrane><Mycobacterium bovis><Mycobacterium tuberculosis (MTB) infection><Mycobacterium tuberculosis infection><Mycobacterium tuberculosis var. bovis><NIAID><NIH><National Institute of Allergy and Infectious Disease><National Institutes of Health><Norovirus><Norwalk-like Viruses><Nurses><Orthoflavivirus><Outbreaks><PK/PD><Paludism><Parainfluenza><Parasitic Diseases><Patients><Pediatrics><Ph.D.><PhD><Pharmacists><Phase><Plague><Plasmodium Infections><Preparedness><Prevention><Preventive><Procedures><Process><Protocol><Protocols documentation><Qualifying><Quarantine><Readiness><Recombinants><Reporting><Research><Research Personnel><Research Resources><Researchers><Resources><Safety><Salmonella><Sampling><Scientist><Seasons><Services><Sexually Transmitted Diseases><Sexually Transmitted Disorder><Sexually Transmitted Infection><Simplexvirus><Simplexvirus Vaccines><Site><Smallpox><Special Population><Specialist><Standardization><Study 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infection><tuberculous spondyloarthropathy><vaccination study><vaccination trial><vaccine against M. tuberculosis><vaccine against Mtb><vaccine against Mycobacterium tuberculosis><vaccine against TB><vaccine against flu><vaccine against influenza><vaccine against tuberculosis><vaccine against yellow fever><vaccine candidates against tuberculosis><vaccine development><vaccine efficacy><vaccine evaluation><vaccine screening><vaccine study><vaccine testing><vaccine trial><vaccinology><variola major><viral pathogen><virus pathogen><yellow fever virus vaccine><zika fever>