IDCRC Newsletter: April 2022

IDCRC Investigator Profile: Kirsten E. Lyke, MD
 University of Maryland School of Medicine

“The IDCRC/VTEU system provides the infrastructure for funding important vaccine work domestically as well as funds important research towards infectious diseases that plague populations globally.”

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IDCRC Early Career Investigator Pilot Awards – LOI Due May 16

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 researchers begin clinical trial to assess schistosomiasis vaccine

An estimated 200 million people are infected with schistosomiasis and an additional estimated 800 million people are at risk of acquiring the disease. Schistosomiasis, caused by parasitic worms, is estimated to cause 280,000 deaths annually in 78 countries. Infectious Diseases Clinical Research Consortium (IDCRC) researchers are conducting a clinical trial to assess the safety and effectiveness of an investigational schistosomiasis vaccine. The trial could help pave the way for the world’s first vaccine against the disease, offering a safe and cost-effective option to lower its prevalence worldwide and prevent deaths.

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NIH begins clinical trial evaluating second COVID-19 booster shots in adults

Published March 31, 2022

A Phase 2 clinical trial evaluating various additional COVID-19 booster shots has begun enrolling adult participants in the United States. The trial aims to understand if different vaccine regimens—prototype and variant vaccines alone and in combinations—can broaden immune responses in adults who already have received a primary vaccination series and a first booster shot. The study, known as the COVID-19 Variant Immunologic Landscape (COVAIL) trial, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

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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:

  • Remdesivir for the Prevention of Invasive Mechanical Ventilation or Death in Coronavirus Disease 2019 (COVID-19): A Post Hoc Analysis of the Adaptive COVID-19 Treatment Trial-1 Cohort Data 
  • Omicron variant Spike-specific antibody binding and Fc activity is preserved in recipients of mRNA or inactivated COVID-19 vaccines
  • Safety and Immunogenicity of a 100 μg mRNA-1273 Vaccine Booster for Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
  • Initial analysis of viral dynamics and circulating viral variants during the mRNA-1273 Phase 3 COVE trial
  • mRNA-1273 Vaccine-elicited Neutralization of SARS-CoV-2 Omicron in Adolescents and Children
 
 

Training

Mentee Profile: Tara Brinck Reid, MD, PhD, infectious diseases fellow, University of Washington

Dr. Reid's previous work focused on antigenic variation in T. pallidum and the natural history of syphilis infection. Her focus now is on improving our understanding of T cell response to syphilis infection and using this knowledge to inform vaccine design.

IDCRC TRAINING
 

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

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

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.

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 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
     
  • 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
     
  • 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
IDCRC ACTIVE AND COMPLETED STUDIES
 

IDCRC Concept Quick Stats

ICP Status

  • Approved: 31
  • Administratively Not Supported: 18
  • Revise and Resubmit: 6
  • Withdrawn: 8
  • Liaisons: 5
  • EWGs: 3
  • Not Approved: 33
  • EMT: 2
  • Other: 8

EWG Assignment

  • COVID: 81
  • Respiratory: 11
  • Sexually Transmitted Infections: 7
  • Malaria and Tropical Dis.: 5
  • Enteric Inf.: 4
  • Emerging Infections: 6

ECP Status

  • Protocol Development: 5
  • IDCRC concept study underway: 4
  • Moved forward through other processes: 4
  • Pending: 5
  • Not approved: 0
  • In process: 6
  • 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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