IDCRC Newsletter: May 2022

IDCRC Profile:

Seema Nayak, MD

Director, Office of Clinical Research Resources, Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

“The strength of the IDCRC is the components of the network itself. The investigators and their teams, who do high-quality interventional trials every day, and are now training the next generation of infectious disease researchers. The mentorship programs at the IDCRC and growth opportunities for young investigators will continue the legacy of the IDCRC.”

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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:

  • Rapid Decline in Vaccine-Boosted Neutralizing Antibodies Against SARS-CoV-2 Omicron Variant

  • COVID-19 booster vaccination during pregnancy enhances maternal binding and neutralizing antibody responses and transplacental antibody transfer to the newborn

  • SARS-CoV-2 Evolution and Immune Escape in Immunocompromised Patients

  • Baricitinib versus dexamethasone for adults hospitalised with COVID-19 (ACTT-4): a randomised, double-blind, double placebo-controlled tria

  • Serum levels of anti-PF4 IgG after AZD1222 (ChAdOx1 nCoV-19) vaccination

 
 

News

IDCRC Admin Team Transition

Bridget Wynn resigned from the IDCRC in June 2022 and has transitioned to another opportunity within Emory University. Since joining the IDCRC Leadership Group in 2020 Bridget has facilitated many non-monetary agreements, enhanced and managed the 2021 Conflict of Interest process and contributed to many, many grants management tasks for the network. The work and contributions that she has made, including extended hours of serving, are appreciated. Thank you, Bridget!

 

Emory researchers honored with 2022 Health Care Heroes awards

The Atlanta Business Chronicle has selected two Emory researchers as winners of its 2022 Health Care Heroes awards. Nadine Rouphael, MD, professor at Emory University School of Medicine and executive director of the Hope Clinic, the clinical research arm of the Emory Vaccine Center, won as a Health Care Hero in the Innovator/Researcher category.

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David Stephens to serve as Emory’s interim executive vice president for health affairs

Dr. David S. Stephens will serve as Emory University’s interim executive vice president for health affairs (EVPHA) beginning Sept. 1, President Gregory L. Fenves announced.  Stephens has served as vice president for research in Emory’s Woodruff Health Sciences Center (WHSC) since 2007 and as chair of the Department of Medicine in the Emory School of Medicine since 2013.

As interim EVPHA, Stephens will be the senior executive for WHSC and will oversee the Emory Healthcare system strategy.

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Sanofi-GSK next-generation COVID-19 booster delivers strong immune response against variants of concern, including Omicron

Published June 13, 2022

  • Next-generation booster vaccine candidate delivers immune boost in adults primed with mRNA vaccines; with a stronger immune response compared to Pfizer-BioNTech’s Comirnaty booster vaccine
  • Next-generation booster vaccine candidate demonstrates potential to protect against COVID-19 variants of concern, including Omicron BA.1 and BA.2, with a favorable safety and tolerability profile
READ FULL RELEASE
 

Training

Mentee Profile:

Martin Bäcker, MD, FAAP, Clinical Assistant Professor of Medicine in the Division of Infectious Diseases, NYU School of Medicine

IDCRC TRAINING
 

Job Postings

  • NIH Office of Human Resources Director of Vaccine Research Center

  • Southern Research ID positions

Visit the IDSA Career Center to browse over 200 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.

Infrastructure Development Training Programs for Critical HIV Research at Low-and Middle-Income Country Institutions - LOI Due July 22
This FOA encourages collaborative applications from U.S. and LMIC institutions to develop training programs to achieve technical, administrative, and financial management expertise required for one of several research infrastructure support functions considered critical to a successful high-quality research environment.

Accelerating the Prevention and Control of HIV, Viral Hepatitis (VH), STDs, and TB in the U.S. Affiliated Pacific Islands - Due July 29
The purpose of this FOA is to prevent, diagnose and treat HIV, STD, TB and VH. Improve collection, sharing, reporting, analysis, interpretation and use of surveillance and other program data.

Understanding the Clinical History of Bacterial Sexually Transmitted Infections (STI) to Accelerate Diagnostic and Vaccine Development (R01 Clinical Trial Not Allowed) - LOI Due August 12
The purpose of this FOA is to support studies on the clinical history of three STIs: syphilis, gonorrhea and chlamydia. Improved understanding of the human immune response after infection through diagnosis and treatment will provide a much-needed knowledge base to accelerate vaccine and diagnostic development.

Partnerships for Development of Vaccines Against Select Enteric Pathogens (R01 Clinical Trial Not Allowed) – LOI Due August 14
The purpose of this FOA is to solicit research applications focused on advancing development of vaccine candidates against Enterotoxigenic Escherichia coli (ETEC), Salmonella enterica serotype Paratyphi A and two Shigella species, Shigella flexneri and Shigella sonnei.

Enhancing HIV Reservoir Susceptibility to Elimination (R01 Clinical Trial Not Allowed) – Due August 30
The purpose of this FOA is to support basic research to define cellular and molecular mechanisms within persistent HIV reservoir cells that promote survival and resistance to virus-induced and immune-mediated cell death, and to identify novel therapeutic targets that could sensitize HIV-infected cells to eradication strategies.

NIH Director’s Transformative Research Award (R01 - Clinical Trial Optional) – Due September 1
The NIH Common Fund announces the FY2023 funding opportunity for the NIH Director’s Transformative Research Award in the High-Risk, High-Reward Research program. The Transformative Research Award supports individuals or teams proposing unusually innovative research projects that are inherently risky and untested but have the potential to create or overturn fundamental paradigms.

Healthcare Infection Society: Major Research Grant - Due September 1
The purpose of this FOA is to support work on the subject of healthcare-associated infections and infection prevention and control.          

Notice of Special Interest (NOSI): Towards Developing a Cure for HBV in HIV/HBV Co-Infection – Due September 5
The purpose of this NOSI is to encourage applications for support of innovative basic, translational, and clinical research to identify and address the unique challenges to achieving HBV cure in the presence of HIV. 

NIH Director's Pioneer Award (DP1 - Clinical Trial Optional): RFA-RM-22-018 – Due September 9
The NIH Common Fund announces the FY2023 funding opportunity for the NIH Director’s Pioneer Award in the High-Risk, High-Reward Research program. The Pioneer Award supports scientists with outstanding records of creativity proposing pioneering approaches to major challenges in any area of science relevant to the broad mission of NIH.

A Multi-omics Approach to Immune Responses in HIV Vaccination and Intervention (P01 Clinical Trial Not Allowed) – LOI Due September 13
The purpose of this FOA is to support multi-disciplinary, multi-component applications proposing the use of omics technologies to advance preventative and/or therapeutic vaccinations, and/or immunomodulatory cure interventions for HIV. Projects will integrate omics, computational and hypothesis-driven experimental approaches to interrogate immune responses to HIV vaccination and/or cure strategies.

 

IDCRC Studies

Active Studies
Recruiting Volunteers

  • Gritstone Second Generation COVID-19 Vaccine, CORAL Program
     

  • Moderna’s mRNA-1273 vaccine, the KidCOVE Study
  • Heterologous Prime Boost, Mix and Match Study
     
  • Mucosal immunity against GC after 4CMenB Vaccination
     
  • Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine
     
  • COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)
     
  • Safety, Tolerability, and Immunogenicity Study of Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults

Fully Enrolled Studies
in Follow-up

  • Moderna’s mRNA-1273 vaccine, The COVE Study™
     

  • Moderna’s mRNA-1273.351 Variant vaccine
     

  • AstraZeneca Study of AZD1222
     

  • The ENSEMBLE Study with Janssen’s Ad26.COV2.S Investigational Vaccine
     

  • Novavax Study of NVX-CoV2373
     

  • Regeneron’s 10933 and 10987 Monoclonal Antibodies, the REGN-COV2 Study
     

  • Eli Lilly’s LY3819253 Antibody, the BLAZE-2 Study
     
  • SARS-CoV-2/COVID-19 PREVALENCE STUDY, The COMPASS Study
     
  • SARS-CoV-2 Vaccines in Pregnancy and Postpartum, the MOMI-VAX Study
IDCRC ACTIVE AND COMPLETED STUDIES
 

IDCRC Concept Quick Stats

ICP Status

  • Approved: 36

  • Administratively Not Supported: 19

  • Revise and Resubmit: 6

  • Withdrawn: 8

  • Liaisons: 1

  • EWGs: 4

  • Not Approved: 34

  • EMT: 2

  • Other: 8

EWG Assignment

  • COVID: 83

  • Respiratory: 12

  • Sexually Transmitted Infections: 7

  • Malaria and Tropical Dis.: 5

  • Enteric Inf.: 4

  • Emerging Infections: 7

ECP Status

  • Protocol Development: 7

  •  IDCRC concept study underway: 4

  • Moved forward through other processes: 4

  • Pending: 5

  • Not approved: 1

  • In process: 4

  • On hold: 8

  • Withdrawn: 3

NOTE:

  • Protocols Transitioned to IDCRC for Protocol Implementation: 5
  • Status: Protocol Dev/Pre-implementation: 4; Active Study: 1
  • Other studies in process (not from an IDCRC concept): 4
IDCRC STUDIES
 

Communication Resources

COMMUNICATION TOOLKIT
 

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

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