IDCRC Newsletter: July 2023
Spotlight: Seattle IDCRC Site Visits
The IDCRC Leadership Group continues their Vaccine and Treatment Evaluation Units (VTEU) site visits. From June 22-23, 2023, IDCRC PIs, David Stephens, MD, Kathy Neuzil, MD, and Clinical Operations Unit co-director, Jeff Lennox, MD, visited Seattle to meet with the IDCRC Statistical and Data Science Unit (SDSU) and Laboratory Operations Unit (LOU) at Fred Hutchinson Cancer Center, the Kaiser Permanente Washington VTEU, Seattle Children's Research Center, and the University of Washington VTEU. “Overall, this was an excellent and productive visit, an opportunity to interact with two VTEUs and the LOU and SDSU. The collective Seattle teams bring complementary resources to the IDCRC” says Stephens. The Leadership Group thanks these teams again for their hospitality and looks forward to visiting again soon.
Highlights from the most recent grant year were presented by all VTEUs at our 2023 Annual Meeting. This month we are featuring Emory University. Note, these were created by the IDCRC Leadership Operations Center and is not intended to be a comprehensive list.
WHO-approved MenFive, turning point in fight against African forms of meningococcal meningitis
MenFive is now undertaking Phase 3 research in Mali in healthy children aged 9 to 15 months to assess its safety and immunogenicity when provided alongside measles/rubella and yellow fever vaccination.
The Infectious Diseases Clinical Research Consortium is conducting the study in partnership with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Such research might assist to increase the availability of MenFive to protect as many individuals as feasible and promote the objective of eradicating meningococcal meningitis outbreaks in Africa.
IDSA President's Podcast: Communicating with the public during a pandemic with CNN Chief Medical Correspondent
Sanjay Gupta, MD
IDSA President Carlos del Rio MD, FIDSA sits down with CNN Chief Medical Correspondent Sanjay Gupta, MD to discuss lessons learned from the COVID-19 pandemic and how infectious diseases professionals can effectively communicate with decision makers and the public.
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: Erin Nicholson, MD
Assistant Professor, Pediatric Infectious Diseases,
Baylor College of Medicine Dr. Nicholson's research focuses on understanding the pathophysiology of respiratory viruses in young children as well as working to prevent their morbidity and mortality through clinical trials.
NIH Funding Opportunities Specific to COVID-19
This page contains a listing of active and expired funding opportunities. 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.
Pulmonary Outcomes and Sequelae after Treatment-TB (POST-TB) (R01 Clinical Trial Optional) – Due September 7, 2023; January 7, 2024; May 7, 2024; 2025 (Full application)
The purpose of this Notice of Funding Opportunity (NOFO) is to support applications for epidemiological and observational research projects on the long-term cardiopulmonary sequelae following treatment for tuberculosis (TB). Investigators should propose additional testing and data collection in existing cohorts of adult and/or pediatric TB participants to better characterize and understand adverse outcomes and morbidity associated with TB disease post treatment in individuals with and without HIV infection. 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.
NIAID New Innovators Awards (DP2 Clinical Trial Not Allowed) –
Due 30 days prior (LOI); Friday, October 13, 2023; October 11, 2024; October 10, 2025
The purpose of this FOA is to support early career faculty 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.
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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