IDCRC Newsletter: February 2022

IDCRC PI Profile: Daniel Hoft, MD, PhD
Vaccine and Treatment Evaluation Unit
Saint Louis University School of Medicine

"The IDCRC and associated VTEUs are critical for pandemic preparedness, urgent responses to novel worldwide threats and experimental biology studies in humans to further identify important immune targets for improved vaccines."

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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:

  • SARS-CoV-2 Omicron Neutralization After Heterologous Vaccine Boosting
     
  • Prevention and Control of COVID-19: Where do we go from here?
     
  • Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S
     
  • Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico
 

News

Lisa Jackson selected as Researcher of the Year

When the Puget Sound Business Journal honored health care leaders of 2021, they chose Lisa Jackson, MD, MPH, as Researcher of the Year. Jackson is the PI for the Kaiser Washington VTEU, a senior investigator at Kaiser Permanente Washington Health Research Institute (KPWHRI) and a Washington Permanente Medical Group physician. Among other work in vaccines and infectious diseases, she leads trials on COVID-19 vaccines including the first trial of an mRNA vaccine against the disease. 

 

 Sanofi and GSK to seek regulatory authorization for
COVID-19 vaccine

Released February 23, 2022

Sanofi and GSK recently announced that they intend to submit data from both their booster and Phase 3 efficacy trials as the basis for regulatory applications for a COVID-19 vaccine. 

The public health relevance of the refrigerator temperature-stable adjuvanted protein-based Sanofi-GSK vaccine is strongly supported by the induction of robust immune responses and a favorable safety profile in multiple settings. 

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Training

Mentoring Lecture Archive
The Development and Characterization of RSV Live-Attenuated Vaccines
Presenter: Christina Rostad, MD, Emory University

VIDEO ARCHIVE
 

Mentee Profile: Meagan Deming, MD, PhD, Infectious Diseases Fellow, University of Maryland Medical Center

Dr. Deming is a virologist with experience including antibody neutralization and vaccine characterization in mouse models of severe coronavirus infections. She is also an adult infectious disease fellow, currently working on respiratory virus vaccines (coronaviruses and influenza) and improving vaccine responses for immunocompromised hosts.

VIEW PROFILE
IDCRC TRAINING
 

 Drug Development Training Program (DDTP) – Due March 4

DDTP at Genentech is for recent doctoral graduates who are looking to gain hands-on training and mentoring in multiple areas of clinical and pre-clinical drug development. DDTP participants will get the chance to spend three years gaining invaluable, on-the-job experience in one of the functions of the Development Sciences (DevSci) organization based in South San Francisco, California. The DDTP is now recruiting its third class for a September 2022-January 2023 start date. Recent graduates of a doctoral program (e.g. Ph.D., MD/Ph.D., DVM) or in the final year of the doctorate are eligible to apply. Recent graduates are defined as being within two years since graduating from a doctoral program. 

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Job Postings

  • Research Faculty Position - Virology - Laboratory of Biochemical Pharmacology
     
  • Visit the IDSA Career Center to browse over 200 ID/HIV Medicine job postings.
 

Funding Opportunities

Johnson & Johnson QuickFire Challenge: Improving Detection of Neurotoxicity in Immunotherapies – Due March 18
J&J is seeking methods and technologies aiming to optimize patient care for immunotherapies within the hematologic malignancy space by enabling the early detection of neurotoxic events. Of particular interest are technologies aiming to identify clinical manifestations to predict acute toxicities, including movement and neurocognitive disorders. 

Notice of Special Interest: Research on barriers to care and risk of HIV-associated comorbidities among vulnerable population groups – Due May 6
The purpose of this FOA is to support analysis of barriers to care and risk of HIV-associated comorbidities among disproportionally vulnerable and affected population groups of people living with or at risk for HIV infection.

 

IDCRC Studies

Active Studies
Recruiting Volunteers

  • Gritstone Second Generation COVID-19 Vaccine, CORAL Program
     

  • Moderna’s mRNA-1273 vaccine, the KidCOVE Study
     
  • SARS-CoV-2 Vaccines in Pregnancy and Postpartum, the MOMI-VAX 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

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
IDCRC ACTIVE AND COMPLETED STUDIES
 

IDCRC Concept Quick Stats

ICP Status

  • Approved: 29

  • Administratively Not Supported: 17

  • Revise and Resubmit: 6

  • Withdrawn: 8

  • Liaisons: 3

  • EWGs: 4

  • Not Approved: 31

  • EMT: 2

  • Other: 7

EWG Assignment

  • COVID: 77

  • Respiratory: 11

  • Sexually Transmitted Infections: 6

  • Malaria and Tropical Dis.: 4

  • Enteric Inf.: 3

  • Emerging Infections: 6

ECP Status

  • Protocol Development: 5

  • IDCRC concept study underway: 3

  • Moved forward through other processes: 4

  • Pending: 5

  • Not approved: 0

  • In process: 7

  • On hold: 5

  • 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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