IDCRC Newsletter: May 2022

IDCRC Vaccine & Treatment Evaluation Unit Principal Investigator Profile:

Robert W. Frenck, Jr., MD

Cincinnati Children's Hospital Medical Center Vaccine and Treatment Evaluation Unit

“The principal strength of the IDCRC is the network of investigators and sites throughout the country who bring expertise in multiple areas of infectious diseases and conduct of clinical trials. This expertise allows for the rapid development and implementation of protocols to evaluate preventions and treatments of infectious diseases. Additionally, the highly respected research teams at the various IDCRC sites translates to very rapid enrollment and extremely high retention rates of study participants in the various studies. Both are critical for the acquisition of high-quality data, a longstanding hallmark of the VTEUs, and why the VTEUs, and now the IDCRC have been recognized by the NIH as a crown jewel in their clinical trial networks.”

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IDCRC Early Career Investigator Pilot Awards –  Applications Due June 30

Mentored Pilot Research Project awards (similar to K08, K23 and K99 awards) provide 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 (e.g., acquisition of preliminary data, training in grant preparation). The projects can address a variety of topics, including vaccinology, therapeutics, laboratory studies and statistics. Scientists (MD, PhD or equivalent) nearing completion of postdoc or in early faculty positions (instructor or assistant professor) and those whom not have served as principal investigator (PI) or MPI on an R-grant (other than an R03) with NIH are eligible. Serving as PI on a K-series or other mentored career award does not preclude eligibility.

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News

IDCRC mentee, Zanthia Wiley, named into the Infectious Diseases Society of America’s 2022 Leadership Institute Community Leaders

Zanthia Wiley, MD, was named one of 32 individuals accepted into the Infectious Diseases Society of America's (ISDA) 2022 Leadership Institute Community of Leaders.

The ISDA's Community of Leaders focuses on mid- and senior career professionals seeking to join an ever-growing community of professionals seeking to accelerate their careers and amplify change initiatives

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VTEU PI, Carlos del Rio, named to American Academy of Arts and Sciences

Carlos del Rio, MD, was one of four Emory University faculty members have been elected to the American Academy of Arts and Sciences, one of the nation’s oldest and most prestigious honorary societies and a leading center for independent policy research.

The Emory professors are among 261 newly-elected members of the American Academy, which was founded in 1780 by John Adams, John Hancock and others who believed the new republic should honor exceptionally accomplished individuals and engage them in advancing the public good. The academy’s dual mission remains essentially the same more than 240 years later, with honorees from increasingly diverse fields and with work focused on the arts, democracy, education, global affairs and science.

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IDCRC leader, Jeanne Marrazzo’s audio interview by NEJM: Communicating COVID-19 Science

In this audio interview conducted on April 26, 2022, the editors are joined by infectious disease specialist Jeanne Marrazzo to discuss how to effectively communicate Covid-19 science, as well as how to use existing therapies judiciously.

LISTEN HERE
 

FDA Approves Lilly and Incyte's OLUMIANT® (baricitinib) for the Treatment of Certain Hospitalized Patients with COVID-19

Published May 11, 2022

Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced that the U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) with a recommended dose of 4-mg once daily for 14 days or until hospital discharge, whichever comes first.

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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:

  • Multi-site observational maternal and infant COVID-19 vaccine study (MOMI-vax): a study protocol
  • Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age
  • Safety and Immunogenicity of a Third Dose of SARS-CoV-2 mRNA Vaccine — An Interim Analysis​​​​​​​
  • Could widespread use of antiviral treatment curb the COVID-19 pandemic? A modeling study
  • Impact of preexisting anti-Ad26 humoral immunity on immunogenicity of the Ad26.COV2.S COVID-19 vaccine
  • Trajectory of Viral RNA Load Among Persons With Incident SARS-CoV-2 G614 Infection (Wuhan Strain) in Association With COVID-19 Symptom Onset and Severity​​​​​​​
  • Preserved Omicron Spike specific antibody binding and Fc-recognition across COVID-19 vaccine platforms
  • Serum Neutralizing Activity of mRNA-1273 against SARS-CoV-2 Variants​​​​​​​
  • Calibration of Two Validated SARS-CoV-2 Pseudovirus Neutralization Assays for COVID-19 Vaccine Evaluation​​​​​​​
 
 

Training

Mentee Profile:
Angelica Cifuentes Kottkamp, MD
,
Assistant Professor, Department of Medicine at NYU Grossman School of Medicine

Dr. Kottkamp’s research focuses on viruses, immune response and vaccinology.

IDCRC TRAINING
 

Mentoring Lecture Archive

Impostor Syndrome
Presenter: Anna Wald, MD, MPH, University of Washington

VIDEO ARCHIVE
 

Job Postings

  • Southern Research ID positions focused on flu research: Scientist I and Senior Scientist

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.

Human Vaccine Project: Michelson Prizes – Due June 24
The purpose of this FOA is to support promising researchers who are applying disruptive concepts and inventive processes to advance human immunology, vaccine discovery, and immunotherapy research for major global diseases.

Michelson Medical Research Foundation Next Generation Grants – Due June 26
Annual awards of $150,000, which support young investigators (35 and under) who are working to significantly advance human immunology and vaccine and immunotherapy research for major global diseases. The awards committee is looking for research aimed at tackling the current roadblocks that exist in human vaccine development and expanding our limited understanding of key immune processes that are fundamental to successful vaccine and immunotherapy development. Applicants from the full spectrum of immunology-related disciplines, including clinical research, biochemistry, molecular biology, protein engineering, computer science, artificial intelligence/machine learning, biophysics, environmental health, nanotechnology, etc., are encouraged to apply. 

Development and Optimization of Next-Generation Immunological Assays to Support Influenza Clinical Studies and Trials (UH2/UH3 Clinical Trial Not Allowed) – Due July 1
The purpose of this FOA is to solicit applications for collaborative, multidisciplinary research to develop and optimize next-generation immunological assays that will be readily utilized for influenza clinical studies and trials by the end of the UH2/UH3 project period.

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.

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.

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.

 

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: 31 

  • Administratively Not Supported: 19

  • Revise and Resubmit: 6

  • Withdrawn: 8

  • Liaisons: 0

  • EWGs: 6

  • Not Approved: 34

  • EMT: 3

  • Other: 8

EWG Assignment

  • COVID: 82

  • Respiratory: 11

  • Sexually Transmitted Infections: 7

  • Malaria and Tropical Dis.: 5

  • Enteric Inf.: 4

  • Emerging Infections: 6

ECP Status

  • Protocol Development: 6

  •  IDCRC concept study underway: 4

  • Moved forward through other processes: 4

  • Pending: 6

  • 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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