IDCRC Newsletter: December 2023

As 2023 comes to a close, the IDCRC would like to extend our gratitude to all of our members and partners for your efforts and dedication this year. We wish you and your loved ones a joyous holiday season and a happy new year!

 

IDCRC Profile: Mallory Shriver, MS

Mallory is a lead research project coordinator for the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine. She has been a vital member of UMB’s VTEU, supporting COVID-19 clinical trials including her part in helping develop and qualify the Meso Scale Discovery (MSD) platform for measurement of mucosal Ab responses for Mix and Match and MOMI-Vax.

Mallory will be pursuing other opportunities and leaving the University of Maryland. We thank her for her contributions to the IDCRC and wish her all the best in her future endeavors.

VIEW PROFILE
 

Announcing the 2023-2024 Pilot Award Recipients

Congratulations to our new Pilot Award recipients! We are thrilled to welcome the following researchers to this program.

The Pilot Grants program provides one-year of funding to support research projects and career development activities that will enhance the applicant’s ability to compete successfully for an independent R- or K-series award. The projects can address a variety of topics, including vaccinology, therapeutics, laboratory studies and statistics. Visit our website to learn more about the program and awardees. 

Juan Calix, Jr., MD, PhD
Assistant Professor
University of Alabama at Birmingham 

Andrew Cox, MD, PhD
Clinical Fellow
Cincinnati Children's Hospital Medical Center

Jose Lemme, PhD
Research Associate,
University of Maryland

Stephanie McLaughlin, MD, MPH
Acting Instructor, Attending Physician, University of Washington

Laura Matrajt, PhD
Staff Scientist,
Fred Hutch Cancer Center

 

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:

  • Endpoint Lab Oversight
  • PBMC Proficiency and Immunology Quality Assurance (IQA) Process
 
VIEW ALL SECTIONS
 

Seeking Clinical Collaborators

CDC/NIH collaborative study (VIRISMAP, NCT06045923) looking for clinical collaborators

The CDC and NIH are currently working on a collaborative study called “Virologic and immunologic characteristics of severe mpox among persons with advanced HIV (VIRISMAP)” (NCT06045923), to enhance knowledge of mpox pathogenesis in severely immunocompromised people, which can inform treatment and prevention of severe illness and deaths associated with mpox in people with advanced HIV.

VIRISMAP is a prospective cohort study enrolling eligible in-patients who are hospitalized with mpox (though the diagnosis of mpox does not need to be new) at collaborating clinical sites and gather clinical and laboratory data during their hospitalizations. Enrollment in this study should not preclude involvement in other trials (e.g. STOMP). Direct financial compensation is not available, but other resources to support study activities will be provided by CDC/NIH.

Those with interest in becoming a clinical collaborator or additional questions can email poxvirus@cdc.gov.

MORE INFO
 

VTEU Highlight 

University of Rochester

Highlights from the most recent grant year were presented by all VTEUs at our 2023 Annual Meeting. This month we are featuring the University of Rochester. Note, these were created by the IDCRC Leadership Operations Center and is not intended to be a comprehensive list. 

 
VIEW PDF VERSION
 

Publications

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:

  • Examining protective effects of SARS-CoV-2 neutralizing antibodies after vaccination or monoclonal antibody administration
  • Evaluating Demographic Representation in Clinical Trials: Use of the Adaptive Coronavirus Disease 2019 Treatment Trial (ACTT) as a Test Case
  • Kinetics of the Antibody Response to Symptomatic SARS-CoV-2 Infection in Vaccinated and Unvaccinated Individuals in the Blinded Phase of the mRNA-1273 COVID-19 Vaccine Efficacy Trial
  • A Prospective Study of Key Correlates for Household Transmission of Severe Acute Respiratory Syndrome Coronavirus 2
 

News

More than US$ 1.8 billion in support for African vaccine manufacturing, catching up missed children and pandemic preparedness approved as Gavi Board steps up efforts to tackle backsliding and fight health emergencies

The Board of Gavi, the Vaccine Alliance announced a series of decisions to help lower-income countries tackle backsliding from the COVID-19 pandemic and be better prepared to respond to future health emergencies. The decisions were taken during a two-day meeting hosted by the Government of Ghana in Accra, Ghana, from December 6-7.

Following more than 18 months of close collaboration between Gavi, the African Union, and Africa CDC, the Board approved the establishment of the African Vaccine Manufacturing Accelerator (AVMA).  AVMA is an innovative financing mechanism aimed at establishing a sustainable African vaccine manufacturing industry capable of improving the region’s resilience in the face of pandemics, outbreaks and other health emergencies as well as the health of global vaccine markets.

VIEW PRESS RELEASE
 

Meet UMB’s Researcher of the Year: Kathy Neuzil

Kathy Neuzil is the Myron M. Levine, MD, DTPH Professor of Vaccinology at the University of Maryland School of Medicine (UMSOM) and has been director of its Center for Vaccine Development and Global Health (CVD) since 2015. An internationally renowned researcher, Neuzil is sought after by the news media as a vaccine expert and is a member of the National Academy of Medicine, an elite honor reserved for individuals who have made major contributions to advancing medical science, health care, and public health.

“Dr. Neuzil is a thought leader who has made pivotal contributions toward advancing the clinical science of vaccines against respiratory viruses, rotavirus, and, more recently, typhoid fever. She is a compelling speaker and advocate who seizes on critical issues and motivates the actions needed to evaluate and implement public health interventions.”
—Karen Kotloff, MD, Distinguished University Professor, UMB, and John A. Scholl, MD and Mary Louise Scholl, MD Professor of Pediatrics, UMSOM

READ ARTICLE
 

Carlos del Rio, MD, named one of Georgia's Most Influential Leaders in Healthcare

Carlos del Rio, MD, Emory Vaccine Center VTEU PI, was recently named one of Georgia Trend's 500 Most Influential Leaders in Healthcare. He receives this recognition for his decades of patient care, infectious disease and global health research, medical education, and healthcare administration.

VIEW RECOGNITION
 

How Disease Risk for RSV in Seniors May be Considered Towards Vaccine Application

RSV may not get as much attention for seniors as other conditions associated with older adults; however, one clinician believes the virus should. “We've done a number of studies, both here in the United States and around the world, that's really demonstrated that there's this bimodal incidence of severe disease and incidence of disease in general, that attacks the very young and the very old,” said Angela Branche, MD, associate professor of medicine, University of Rochester. 

READ ARTICLE & WATCH INTERVIEW
 

Training

Mentee Profile: Shannon Walker, MD

Assistant Professor of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center

Dr. Walker’s research focuses on hemostasis and thrombosis, predictive modeling, and hematology-related vaccine complications. Additionally, she is an investigator on pediatric and adult COVID-19 vaccine studies through the
Vanderbilt Vaccine Research Program.

IDCRC Mentees
 

Job Postings

 Infectious Diseases Research Job Openings

  • Tulane University - Infectious Diseases Physician-scientist

  • University of Buffalo - Clinical Assistant, Associate, or Full Professor - Division of Infectious Diseases, Department of Pediatrics

  • University of Pittsburgh - Associate/Assistant Professor of Epidemiology (Infectious Diseases)

  • Vanderbilt University Medical Center - Clinical/Translational Research Coordinator IV - Peds Infectious Disease

  • Cincinnati Children's Hospital Medical Center - Professor, Division Director, Infectious Diseases

  • Center for Vaccine Development and Global Health (CVD) and the Institute for Genome Sciences (IGS) at the University of Maryland School of Medicine - Computational Biology/Bioinformatics (Assistant Professor or higher)

  • Murdoch Children's Research Institute - Ruth Bishop Research Fellowship

  • National Institute of Allergy and Infectious Diseases (NIAID) - Staff Clinician (Physician) - Vaccine Research Center

  • Emory University - Post Doctoral Fellow - Emory Vaccine Center

  • Baylor College of Medicine ​​​​​​- Assistant Professor at the Vaccine Research Center 

  • UT Southwestern Medical Center - Senior Research Associate, Infectious Diseases

  • Joint ID/EIS Fellowship

Visit the IDSA Career Center to browse other ID/HIV Medicine job postings.

 

Funding Opportunities

NIH Funding Opportunities Specific to COVID-19
This page contains a listing of active and expired funding opportunities.   

Computational Models of Influenza Immunity (U01 Clinical Trial Not Allowed) – Due January 26, 2024
The purpose of this FOA is to employ computational modeling and immunologic studies to advance our understanding of the requirements for improving anti-influenza immunity, including inducing broad immune protection and enhancing immune durability.

Notice of Special Interest (NOSI): Development of Organotypic Culture Models for Transplantation Immunology Research – Due February 5, 2024
This Notice of Special Interest (NOSI) encourages applications that focus on the development and validation of tissue-, stem-, or progenitor-cell-derived “3D” organotypic culture models (OCM) for transplantation immunology research.

NIAID Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional) – Due February 5, 2024; June 5, 2024; October  5, 2024; February 5, 2025; June 5, 225
The purpose of this funding opportunity announcement is to encourage applications for research projects within the NIAID mission. This FOA seeks to support either (a) a New Investigator (NI), an individual who has not previously competed successfully for substantial, independent funding from NIH, or (b) are an 'At-Risk' investigator, an individual who had prior support as a PD/PI on a substantial independent research award and unless successful in securing a substantial research grant award in the current fiscal year, will have no substantial research grant funding in the following fiscal year, from diverse backgrounds, including those from groups underrepresented in the health-related sciences.

Global Infectious Disease Research Administration Development Award for Low-and Middle-Income Country Institutions (G11 Clinical Trial Not Allowed) – Due March 13, 2024
The purpose of this notice of funding opportunity (NOFO) is to invite applications from research institutions in low- and middle-income countries (LMICs) to provide senior administrators from these institutions with advanced training in the management of NIH grants. The goal is to improve oversight of NIAID grant awards and compliance with NIH funding policies and Federal research funding requirements for NIAID-supported foreign institutions in LMICs.

NIAID Investigator Initiated Program Project Applications (P01 Clinical Trial Not Allowed) – Due June 8, 2024; 2025
This Funding Opportunity Announcement (FOA) invites submission of investigator-initiated Program Project (P01) applications. The proposed programs should address scientific areas relevant to the NIAID mission including: biology and pathogenesis of infectious microbes, including HIV; host-microbe interactions; mechanisms regulating immune system development and function across the lifespan, and in response to infectious pathogens; immune dysfunction resulting in allergy, asthma, autoimmunity, immunodeficiency, or transplant rejection; and translational research to develop vaccines, therapeutics, and diagnostics to prevent and treat infectious and immune-mediated diseases. Each P01 application submitted to this FOA must include at least two related, synergistic research projects that share a common central theme, focus, and/or overall objective; and an administrative core. A P01 may include scientific cores, if needed for the proposed research.

International Research in Infectious Diseases (R01 Clinical Trial Not Allowed) – Due August 2, 2024; 2025
The purpose of this Funding Opportunity Announcement (FOA) is to support applications for high-priority, regionally relevant infectious diseases research by international investigators in resource-constrained countries. Applicant organizations must be headquartered in foreign (non-U.S.) resource-constrained countries (i.e. low-income economies, lower-middle-income economies, and upper-middle-income economies by World Bank Classification).

NIAID New Innovators Awards (DP2 Clinical Trial Not Allowed) – Due 30 days prior (LOI); 10/11/2024; 10/10/2025  (Full app)
The NIAID New Innovator Award supports postdoctoral and other candidates in non-independent positions or newly independent Early Stage Investigators of exceptional creativity who propose novel, original and insightful research concepts with the potential to produce a major impact, test scientific paradigms, or advance key concepts on broad, important problems in biomedical research of priority to NIAID. Applications proposing unexpected convergence of disciplines, new scientific directions, or the use of novel methodologies are encouraged. Applications from individuals with diverse backgrounds and in any topic relevant to the mission of NIAID are welcome.

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.

Notice of Special Interest (NOSI): Using Targeted Degradation of Protein and non-Protein Targets for the Development of Novel Anti-Infectives – Due July 17, 2026
The purpose of this Notice of Special Interest (NOSI) is to invite applications for research on the use of targeted protein and nonprotein degradation (e.g., RNA) as it relates to the development of anti-infective strategies against viral, bacterial, parasitic, and fungal pathogens and/or their toxins (e.g., Lethal and Edema Toxins of Bacillus anthracis). Both novel monofunctional (e.g., Molecular Glues) and hetero-bi/tri-functional (e.g., PROTAC or PROTAC-like) strategies will be considered.

 

IDCRC Studies

Active Studies
Recruiting Volunteers

  • Safety and Immunogenicity of CJCV2 With and Without ALFQ (DMID 19-0003)
     

  • Pharmacokinetic Study of IV Aresunate to Treat Children With Severe Malaria (DMID 19-0007)

Fully Enrolled Studies
in Follow-up

  • Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine
     

  • Safety, Tolerability, and Immunogenicity Study of Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults
     

  • Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine (DMID 20-0024)
     

  • Moderna’s mRNA-1273 vaccine, the KidCOVE Study (mRNA-1273-P204)

IDCRC ACTIVE AND COMPLETED STUDIES
 

IDCRC Concept Quick Stats

ICP Status

  • Approved: 52

  • Administratively Not Supported: 28

  • Not Approved: 49

  • EWG Review: 0

  • EWG Liaisons: 0

  • EMT Concurrence: 0

  • Withdrawn: 15

  • Hold: 0

  • Moved to Active Study: 2

EWG Assignment

  • COVID: 92

  • Respiratory: 26

  • Emerging Infections: 12

  • Enteric Inf.: 7

  • Malaria and Tropical Dis.: 13

  • Sexually Transmitted Infections: 14

EVCP Status

  • EWG Review-In Process: 3

  • EMT Review: 1

  • Approved-moved to Prioritization: 3

  • Not Approved: 13

  • Approved-moved to Protocol development: 3

  • Study in Protocol Development: 3

  • Active Study: 5

  • Study Closed (LSLV Complete): 4

  • EMT Vote: 0

  • Other: 10

IDCRC STUDIES
 

Communication Resources

COMMUNICATION TOOLKIT
 

Please submit IDCRC news to idcrc@emory.edu for inclusion in the monthly newsletter and IDCRC.org.

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Woodruff Health Sciences Center
Emory University
1440 Clifton Road NE
Atlanta, GA 30322, United States

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