IDCRC Newsletter: June 2023
IDCRC Investigator Profile: Karen Kotloff, MD
Karen Kotloff is the John A. Scholl, MD and Mary Louise Scholl, MD Distinguished Professor; head of infectious disease and tropical pediatrics, in the Department of Pediatrics; associate director of clinical research at the Center for Vaccine Development and Global Health; and PI of the University of Maryland, Baltimore VTEU at the University of Maryland School of Medicine. Kotloff is a pediatric infectious disease physician, conducting clinical trials and studies in infectious diseases for the past 40 years. Her research focuses on measuring infectious disease burden and conducting vaccine trials to reduce that burden, especially from enteric infections. She has conducted trials of vaccines and other interventions to prevent Shigella and other enteric infections
such as cholera, typhoid, and Clostridium difficile, respiratory pathogens such as influenza and coronavirus, and invasive bacterial infections such as group A streptococcus and Staph aureus.
Manual of Procedures Sections
View approved IDCRC Manual of Procedures (MOP) sections which describe structure, operating policies, roles and responsibilities of entities and individuals within the unit/consortium:
Cincinnati Children's Hospital Medical Center
Highlights from the most recent grant year were presented by all VTEUs at our 2023 Annual Meeting. This month we are featuring Cincinnati Children's Hospital Medical Center. Note, these were created by the IDCRC Leadership Operations Center and are not intended to be a comprehensive list.
ID specialists are critical to the health preparedness workforce but need support
Infectious diseases doctors are unique in terms of the wide range of pathogens they prevent, research, diagnose and treat, and the critical parts they play across different health care settings and areas of public health. But nearly 80% of U.S. counties don’t have a single ID physician, and the majority of communities, especially in rural areas, have little or no access to ID experts. You might say they’re a bit like unicorns, as IDSA Treasurer Jeanne Marrazzo, MD, MPH, FIDSA, suggested during a conversation on the health preparedness workforce earlier this month in Washington, D.C. IDSA partnered with Axios for the event, which focused on how health care providers, federal agencies and policymakers can
bolster the health workforce and improve pandemic preparedness.
Global health advocate Dr. Maria Elena Bottazzi wins
Vilcek-Gold Award
The Vilcek Foundation and The Arnold P. Gold Foundation have announced they will bestow the 2023 Vilcek-Gold Award for Humanism in Healthcare on Dr. Maria Elena Bottazzi at the Association of American Medical Colleges (AAMC) meeting in Seattle on November 4, 2023. The Vilcek-Gold Award is a shared initiative of the Vilcek Foundation and the Gold Foundation that embodies the missions of both organizations. The award recognizes an outstanding immigrant healthcare professional in the United States and honors the positive impact that accessible and humanistic care has on public health.
NIH-funded Emory Clinical Trials Unit welcomes new principal investigators to help advance HIV/AIDS research
In 2020, the National Institutes of Health (NIH) selected the Emory Clinical Trials Unit (CTU) as one of 37 CTUs responsible for implementing the scientific agenda of the NIH HIV/AIDS clinical research network. For the first three years of the project, principal investigators Jeffrey Lennox, MD, professor of medicine in infectious diseases and associate dean for clinical research at Emory School of Medicine, and Carlos del Rio, MD, professor of medicine in infectious diseases and interim dean of Emory School of Medicine, have overseen clinical trials conducted at five research sites across three continents. Effective June 1, Lennox and del Rio stepped down from their roles as co-principal investigators to
become CTU investigators and Directors Emeriti of the CTU and two new clinical researchers are assuming leadership of the CTU moving forward. Bringing extensive experience in infectious disease research, Ighovwerha (Igho) Ofotokun, MD, and Colleen Kelley, MD, will look to build on the legacy of Lennox and del Rio and continue to leverage the CTU to advance HIV clinical trials and trials in emerging infections that affect the HIV/AIDS community.
NOTE: Please include the following citation in any publications resulting from direct or indirect IDCRC support: "Supported by the Infectious Diseases Clinical Research Consortium through the National Institute for Allergy and Infectious Diseases of the National Institutes of Health, under award number UM1AI148684. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health."
View recent publications below:
Mentee Profile: Satochi Kamidani, MD
Assistant Professor, Pediatric Infectious Diseases,
Emory Unversity (Children's Center) Dr. Kamidani’s research has focused on vaccine safety, vaccine effectiveness, and the epidemiology of vaccine preventable diseases. He has evaluated COVID-19 vaccine effectiveness in children and adolescents and COVID-19 vaccine safety. He has also investigated the epidemiology and clinical outcomes of influenza-associated hospitalizations following the 2009 H1N1 pandemic.
Assistant/Associate Professor at the Vaccine Research Center at Baylor College of Medicine
The Vaccine Research Center at Baylor College of Medicine (BCM) in Houston, Texas is seeking an Infectious Diseases clinical investigator with interest in the field of clinical vaccine development. The successful candidate must hold a MD (or equivalent). Adult and pediatric Infectious Diseases specialists will be considered. They must have or be eligible for licensure in Texas. Activities will include the development, implementation, and reporting of clinical trials, patient care/clinical responsibilities, and education of students, residents, and fellows. Candidates with laboratory capabilities will also be considered. The BCM Vaccine Research Center is an integrated and interactive group composed of adult and pediatric Infectious
Diseases specialists with interests in respiratory, gastrointestinal and emerging pathogens, and whose clinical research activities are federally- and industry-supported. The BCM Vaccine Research Center houses one of 10 NIH funded Vaccine Treatment and Evaluation Units (VTEUs) in the country Applicants should apply at the button below and forward their curriculum vitae for consideration to bosshard@bcm.edu.
NIH Funding Opportunities Specific to COVID-19
This page contains a listing of active and expired funding opportunities. Fundamental Research to Understand the Mechanisms of Neurotropic Virus-mediated Disease (R01 Clinical Trial Not Allowed) – Due July 25, 2023
The purpose of this Notice of Funding Opportunity (NOFO) is to promote basic research to better understand the mechanisms underlying viral invasion of the central nervous system (CNS), virus- and/or host immune-mediated neuropathogenesis, and the associated clinical manifestations for emerging and re-emerging neurotropic viruses. Bioinformatics Resource Centers (BRCs) for Infectious Diseases (U24 Clinical Trials Not Allowed) – Due 30 days prior (LOI); Friday, August 25 (Full application)
The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications for the Bioinformatics Resource Center (BRC) Program that will (1) create and manage integrated knowledgebases to accelerate basic and applied human infectious diseases research, (2) develop advanced innovative bioinformatics technologies for software and tools, (3) offer state-of-the-art bioinformatics expertise for investigators and (4) respond with cutting-edge bioinformatics in response to emerging needs, outbreaks, and public health emergencies.
International Research in Infectious Diseases (R01 Clinical Trial Not Allowed)
– Due 30 days prior (LOI); Wednesday, August 2, 2023; 2024; 2025 (Full application)
The purpose of this FOA is to support applications for high-priority, regionally relevant infectious diseases research by international investigators in resource-constrained countries. NIAID Resource-Related Research Projects (R24 Clinical Trial Not Allowed) –
Due 30 days prior (LOI); September 25, 2023; 2024; 2025 (Full application)
The purpose of this Funding Opportunity Announcement (FOA) is to propose resources that provide significant benefit to currently funded high priority projects in need of further coordination and support in the areas specified. Under rare circumstances, this mechanism may be used to support development of a new resource to the broader scientific community of the NIAID. Notice of Special Interest (NOSI): Halting Tuberculosis (TB) Transmission – Due January 07, 2026
The purpose of this Notice of Special Interest (NOSI) is to highlight NIAID’s interest in accepting applications that aim to understand the critical drivers of Tuberculosis (TB) transmission at the individual and population levels in high-burden settings. Applicants are encouraged to develop effective methods to measure rates of TB transmission that rely on an increased understanding of the biomedical basis of transmission and related risk factors and to develop and assess potential interventions, including low-cost and low-tech options, to prevent TB transmission. Notice of Special Interest (NOSI): Complement in Fundamental Immunology – Due January 08, 2026
The main objective of this program is to support studies that accelerate our understanding of the roles of complement components and/or receptors in the initiation, magnitude, maintenance, and quality of immune responses involved in pathogenic infections, vaccination, post-infection sequelae, autoimmunity, allergy, or transplantation. The results of such studies will inform the development of vaccines or therapeutics that target complement components. The work to be encouraged includes studies of the roles of complement components (molecules and/or receptors) during immune responses. Advancing Research Needed to Develop a Coccidioidomycosis (Valley fever) Vaccine –Due January 15, 2026
The purpose of this Notice of Special Interest (NOSI) is to highlight NIAID’s interest in supporting research in the areas outlined in the NIAID Strategic Plan For Research To Develop A Valley Fever Vaccine. The proposed research should have clear relevance to the strategic priorities defined in the strategic plan, which encompasses three major research areas: 1) address gaps in Coccidioides basic research to support the development of a vaccine; 2) develop tools and resources to support vaccine development; 3) develop and advance vaccines to prevent coccidioidomycosis.
Active Studies
Recruiting Volunteers
A Phase 2 Randomized, Open-Label, Multisite Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Vaccine
- Safety and Immunogenicity of CJCV2 With and Without ALFQ
Fully Enrolled Studies
in Follow-up
Moderna’s mRNA-1273 vaccine, The COVE Study™
Moderna’s mRNA-1273 vaccine, the KidCOVE Study
AstraZeneca Study of AZD1222
The ENSEMBLE Study with Janssen’s Ad26.COV2.S Investigational Vaccine
Novavax Study of NVX-CoV2373
- SARS-CoV-2 Vaccines in Pregnancy and Postpartum, the MOMI-VAX Study
- Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine
- Gritstone Second Generation COVID-19 Vaccine, CORAL Program
COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)
Heterologous Prime Boost, Mix and Match Study
- Mucosal immunity against GC after 4CMenB Vaccination
Safety, Tolerability, and Immunogenicity Study of Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults
IDCRC Concept Quick Stats
ECP Status Prioritization/
Protocol Development: 14 IDCRC concept study underway: 4 Moved forward through other processes: 4 Pending: 3 Not approved: 11 In process: 4 On hold: 4 Withdrawn/
Halted: 7
NOTE: - Protocols Transitioned to IDCRC for Protocol Implementation: 5
- Status: Protocol Dev/Pre-implementation: 1; Active Study: 3; Halted 1
- Other studies in process (not from an IDCRC concept): 5
Please submit IDCRC news to epthomp@emory.edu for inclusion in the monthly newsletter and IDCRC.org.
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