IDCRC Newsletter: March 2022

IDCRC Profile: Jeffrey S. Gerber, MD, PhD
Children’s Hospital of Philadelphia (CHOP) Research Institute

"The experience and perspective of the IDCRC is invaluable for prioritizing, leading and interpreting studies. As an example, pediatric vaccine trial design requires a nuanced understanding of not only the pathogen and host, but pragmatic issues that will maximize participation and retention of families. The IDCRC has the expertise to integrate the consideration of these elements into the protocol."

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Manual of Procedures Sections

View approved IDCRC Manual of Procedures (MOP) sections which describe structure, operating policies, roles and responsibilities of entities and individuals within the unit/consortium:

  • Publications Requirements and Procedures
 
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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 publication below:

  • Heterologous Covid-19 Booster Vaccinations
 
 

News

IDCRC researchers study several COVID-19 variant vaccines

Published March 29, 2022

Researchers and leadership from the IDCRC and other sites across the country (in collaboration with NIAID) have launched a Phase 2 clinical trial to evaluate the safety and efficacy of additional doses of prototype and variant (alone or in combination) COVID-19 vaccine candidates in previously vaccinated participants with or without prior SARS-CoV-2 infection. The COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial) will also evaluate innate, cellular and humoral immune responses to inform on how to shift the immune response to cover new SARS-CoV-2 variants as they emerge. This research is crucial to inform decisions about additional booster doses to protect against rapidly evolving variants.

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IDCRC researchers assess meningococcal vaccine for infants and young children in Africa

Published March 23, 2022

Researchers from the IDCRC are conducting a study to evaluate the use of a pentavalent – or five in one – meningococcal conjugate vaccine (NmCV-5) among infants and young children in the meningitis belt of sub-Saharan Africa. This is the final and pivotal study for World Health Organization (WHO) prequalification of this vaccine, which is the last stage to make the vaccine available for low- and middle-income countries.

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Moderna says its coronavirus vaccine for young children is safe, but efficacy is a more complicated picture

Published March 23, 2022

Vaccine maker Moderna recently announced its two-dose pediatric coronavirus vaccine was safe in young children, toddlers and babies in a study. But the effectiveness of the shot in children six months to five years old was more of a mixed picture because of the challenge presented by the omicron variant.

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Events

National Foundation for Infectious Diseases 2022 Annual Conference on Vaccinology Research

April 11-12, 2022 | Virtual

The Annual Conference on Vaccinology Research (ACVR) brings together the diverse disciplines involved in vaccine research, development, implementation, and real-world evaluation. By drawing upon an international audience of scientists and researchers, healthcare professionals, vaccine manufacturers, and public health officials, the conference is designed to facilitate the exchange of ideas across a broad range of disciplines.

LEARN MORE & REGISTER
 

NIH Workshop: Precision Probiotic Therapies—Challenges and Opportunities

April 26-27, 2022 | Virtual

The goals of this workshop are to: 1) identify gaps in our current understanding of the biology of the gut microbiota and of probiotics and 2) identify research questions and methodological challenges posed by those gaps. Knowledge developed through these activities will provide a critical foundation for future research efforts to develop “precision probiotic therapies.”

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Training

Mentoring Lecture Archive
How to Grow a Career
Presenter: Cynthia Sears, MD, Johns Hopkins Medical Institute

VIDEO ARCHIVE
 

Mentee Profile: Helen Stankiewicz Karita, MD, Acting Instructor, Division of Allergy and Infectious Diseases, University of Washington

Dr. Karita's research is concentrated on the epidemiology and prevention of HPV-associated cancers. With the advent of the COVID-19 pandemic, her research interest evolved to identifying therapeutics for prevention and early treatment of SARS-CoV-2 infection.

IDCRC TRAINING
 

Joint ID/EIS Fellowship - New Opportunity!

Funded by the CDC, the Joint ID/EIS Fellowship pilot program seeks to develop future public health leaders through an exciting new career opportunity. The Joint ID/EIS Fellowship program combines the ID Fellowship and CDC EIS program, offering a structured opportunity for ID physicians to expand their training in public health and global health.   

LEARN MORE
 

Job Postings

  • Assistant/Associate Professor in Enteric Disease Research at Johns Hopkins Bloomberg School of Public Health
     
  • Infectious Diseases Translational Investigator at Baylor College of Medicine
     
  • 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.

Notice of Special Interest: Administrative Supplements for HIV/AIDS and Aging Research – Due April 25
The purpose of this FOA is to accelerate new knowledge related to the science of HIV and aging, and to expand the pool of researchers conducting studies at the intersection of HIV and aging.

Emergency Awards: RADx®-UP - Social, Ethical, and Behavioral Implications (SEBI) Research on Disparities in COVID-19 Testing among Underserved and Vulnerable Populations – Due May 2
The goal of this FOA is to conduct social, ethical, and behavioral implications (SEBI) research to understand and reduce barriers to COVID-19 testing, as well as COVID-19 disparities that arise from barriers to testing among underserved and vulnerable populations.

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
     
  • 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: 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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Atlanta, GA 30322, United States

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