Document text
Principal Investigator: Karen L. Kotloff
Organization: UNIVERSITY OF MARYLAND BALTIMORE
Fiscal Year: 2021
Award: $1,585,845
Funding agency: National Institute of Allergy and Infectious Diseases
Project Summary/Abstract
The University of Maryland School of Medicine (UMSOM) Center for Vaccine Development and Global Health
(CVD) has been an established VTEU site since 1974. The goal of the VTEUs is to initiate innovative concepts
for clinical research and implement clinical site protocols for evaluating vaccines, other preventive biologics,
therapeutics, diagnostics, and devices for the treatment and prevention of infectious diseases, and CVD is
uniquely poised to accomplish this goal. CVD's expert and accomplished investigative team has
complementary skill sets in all areas necessary to address the NIAID priority areas, with established
management plans to effectively allocate work and conduct multiple projects simultaneously. CVD is
internationally recognized for our capacity and capability to conduct controlled human infection trials for
malaria, influenza, and enteric pathogens and to implement treatment and prevention trials in endemic areas
for malaria and neglected tropical diseases (NTD), both of which have been a focus of its research for many
years. CVD has access to U.S. populations of healthy subjects in all age groups for this research and subjects
with special risks, such as patients attending outpatient clinics with sexually transmitted infection (STI) and
other conditions that generally do not requiring hospitalization. Strong domestic collaborations at sites
experienced in clinical trials provide the CVD's VTEU with surge capacity among healthy subjects of all ages
and vulnerable populations such as pregnant women in the U.S. to address public health emergencies. CVD's
international collaborators, including two long-standing permanent field sites in Africa, are an invaluable
resource for vetted international trial sites in low resource countries endemic for malaria and NTD with
experience in conducting high quality NIAID and VTEU studies. This proposal describes mechanisms to
implement protocols that arise from concepts proposed by the Leadership Group (LG) and the research
community including investigators from other VTEUs, academia, industry, non-governmental organizations,
and DMID. These concepts will focus on NIAID priority areas, including malaria, NTD, respiratory infections,
particularly influenza, enteric diseases, STI, and emerging infectious diseases and other infectious disease
considerations. Under our VTEU contract that is nearing completion (2013-2023), CVD was awarded over 23
Task Orders, enrolled over 1,500 participants, and successfully collaborated with national and international
sites. This renewal application is intended to supplement the new VTEU award (1UM1AI148689) that we
received in December, 2019 in response to AI18-046; funding for this award was limited to one year as a result
of an omission by our Sponsored Programs Administration to include a request for 7 full years of funding. The
current proposal seeks to supplement that one year award with an additional 6 years of funding.
Terms: <Academia><Address><Africa><Ambulatory Care Facilities><Area><Award><Biologic Therapy><Biological Response Modifier Therapy><Biological Therapy><COVID-19><COVID19><CV-19><CV19><Childhood><Clinic><Clinical><Clinical Protocols><Clinical Research><Clinical Study><Clinical Trials><Collaborations><Communicable Diseases><Communities><Conduct Clinical Trials><Consultations><Contracting Opportunities><Contracts><Country><Devices><Diagnosis><Diagnostic><Disease><Disease Outbreaks><Disorder><Ebola><Emerging Communicable Diseases><Emerging Infectious Diseases><Enrollment><Enteral><Enteric><Epidemic><Epidemiologic Research><Epidemiologic Studies><Epidemiological Studies><Epidemiology Research><Equipment><Evaluation><Formulation><Funding><Goals><Government><Grippe><Guidelines><Health><Hospital Admission><Hospitalization><Human><Human Resources><Immune response><Immunological response><Industry><Infection><Infectious Disease Pathway><Infectious Diseases><Infectious Disorder><Influenza><International><Intervention><Intervention Strategies><Investigation><Investigators><Laboratories><Laws><Leadership><Malaria><Manpower><Maryland><Medical Device><Mentors><Methods><Modeling><Modern Man><Moderna COVID-19 vaccine><Moderna coronavirus disease 2019 vaccine><Molecular Marker of Prognosis><NIAID><NIH><National Institute of Allergy and Infectious Disease><National Institutes of Health><Non-governmental Organizations><Nongovernmental Organizations><Organization Charts><Out-patients><Outbreaks><Outpatient Clinics><Outpatients><Paludism><Participant><Patients><Personal Satisfaction><Phase><Plasmodium Infections><Policies><Population><Pregnant Women><Prevention><Prevention trial><Preventive><Prognosis Marker><Prognostic Marker><Program Development><Protocol><Protocols documentation><Public Health><Publishing><Reagent><Regulation><Reporting><Research><Research Personnel><Research Resources><Research Subjects><Researchers><Resources><Respiratory Infections><Respiratory Tract Infections><Risk><Sampling><Schedule><Scientist><Services><Sexually Transmitted Diseases><Sexually Transmitted Disorder><Sexually Transmitted Infection><Site><Source><System><Systems Biology><Therapeutic><United States National Institutes of Health><Universities><Vaccines><Venereal Diseases><Venereal Disorders><Venereal Infections><Vulnerable Populations><Work><access to vaccination><access to vaccines><age group><aged population><aging population><base><biological therapeutic><biological treatment><biotherapeutics><biotherapy><clinical research site><clinical site><corona virus disease 2019><coronavirus disease 2019><design><designing><develop a vaccine><development of a vaccine><dosage><enroll><enteral pathogen><enteric pathogen><enteropathogen><epidemiologic investigation><epidemiology study><evaluate vaccines><expectant mother><expecting mother><experience><global health><healthy volunteer><host response><human subject><immune system response><immunoresponse><improved><innovate><innovation><innovative><interventional strategy><intestinal pathogen><intestine pathogen><mRNA-1273><mRNA1273><medical college><medical schools><microbial consortia><microbial flora><microbiota><microflora><multispecies consortia><neglected tropical diseases><new diagnostics><new vaccines><next generation><next generation diagnostics><next generation vaccines><novel><novel diagnostics><novel vaccines><organizational structure><pathogen><patient population><pediatric><personnel><population aging><population based><pre-clinical><preclinical><predictive biomarkers><predictive marker><predictive molecular biomarker><pregnant mothers><prevent><preventing><product development><prognostic biomarker><prognostic indicator><programs><public health emergency><research study><response><sample collection><school of medicine><serology survey><serosurvey><site targeted delivery><skills><specimen collection><targeted delivery><therapeutic vaccine><tool><treatment trial><treatment vaccines><vaccination access><vaccination availability><vaccine access><vaccine availability><vaccine candidate><vaccine development><vaccine evaluation><vaccine for the treatment><vaccine for treatment><vaccine formulation><vaccine screening><vaccine testing><vulnerable group><well-being><wellbeing>