IDCRC Newsletter: January 2022

IDCRC Profile: Linda McNeil, MA, PMP
Associate Director, Science Facilitation, FHI 360

"While new to the Vaccine & Treatment Evaluation Unit (VTEU) structure, the experience gained from the years of managing domestic and international, multi-center, Phase I, II and III investigational new drug studies, leading monitoring visits to international research sites to ensure compliance with good clinical practices, conducting training workshops internationally on clinical research topics, and contributing to the expansion and global decentralization of FHI 360’s clinical research management responsibilities, have provided the skills and resources essential to the success of the IDCRC award.”

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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:

  • Secondary Research Use of Specimens and/or Data
VIEW ALL SECTIONS
 

News

Mix-and-Match Trial Finds Additional Dose of COVID-19 Vaccine Safe, Immunogenic

News Released January 26, 2022

In adults who had previously received a full regimen of any of three COVID-19 vaccines granted Emergency Use Authorization (EUA) or approved by the Food and Drug Administration (FDA), an additional booster dose of any of these vaccines was safe and prompted an immune response, according to preliminary clinical trial results reported in The New England Journal of Medicine. The findings served as the basis for recommendations by the FDA and the Centers for Disease Control and Prevention in late fall 2021 to permit mix-and-match COVID-19 booster vaccinations in the United States. 

READ NIH RELEASE
READ IDCRC RELEASE
 

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 Variant Neutralization after mRNA-1273 Booster Vaccination
     
  • Homologous and Heterologous Covid-19 Booster Vaccinations
     
  • mRNA-1273 vaccine-induced antibodies maintain Fc-effector functions across SARS-CoV-2 Variants of Concern
     
  • Phase 3 Trial of mRNA-1273 during the Delta-Variant Surge
     
  • Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico
     
  • Booster of mRNA-1273 Vaccine Reduces SARS-CoV-2 Omicron Escape from Neutralizing Antibodies
     
  • Initial Analysis of Viral Dynamics and Circulating Viral Variants During the mRNA-1273 Phase 3 COVE Trial
 

Training

Mentee Profile: Christine Akamine, MD
Assistant Professor, Baylor College of Medicine

Dr. Akamine's research focus is vaccinology and COVID-19 – specifically the clinical and virologic characteristics of patients with prolonged SARS-CoV-2 nucleic acid detection.

VIEW PROFILE
IDCRC TRAINING
 

Job Postings

  • Chief, Respiratory Diseases Branch, NIAID
    The NIAID is seeking an exceptional and visionary leader to be chief of the Respiratory Diseases Branch within the Division of Microbiology and Infectious Diseases (DMID). The chief directs and manages a complex scientific program that stimulates basic, translational, and clinical research and advances product development for respiratory infectious diseases of national and international prominence.
     
  • Faculty Position - Children's Center for Immunity and Applied Genomics (CIAG)
    The Center for Immunity and Applied Genomics (CIAG), a joint entity within Children’s Healthcare of Atlanta and Emory University School of Medicine, invites applications for a tenure eligible position at the Assistant or Associate Professor level, in the broad area of Clinical Genomics (MD and/or PhD required).
     
  • Postdoctoral Fellow - HIV/SIV persistence and cure – Chahroudi Lab
    The Chahroudi laboratory in the Department of Pediatrics at the Emory University School of Medicine is seeking a highly motivated Postdoctoral Research Fellow to lead an NIH-funded project investigating simian immunodeficiency virus persistence in rhesus macaques. The goal of this work is to investigate HIV/SIV cure strategies to reduce the persistent viral reservoir in the setting of postnatal breast milk transmission in an infant nonhuman primate model. 
     
  • Visit the IDSA Career Center to browse over 200 ID/HIV Medicine job postings.

 

Funding Opportunities

  • Notice of Special Interest (NOSI): Advancing Research Needed to Develop a Universal Influenza Vaccine – Due February 4
    The purpose of this NOSI is to continue to foster new and innovative scientific endeavors in all areas defined in the Strategic Plan for the Development of a Universal Influenza Vaccine.
     
  • Strengthening Health Care Infection Prevention & Control (IPC) & Improving Patient Safety in the U.S. – Due February 11
    There is a need to strengthen health care IPC practices, inform IPC recommendations, improve how healthcare personnel IPC competencies are assessed, and develop evidence-based approaches to IPC training and education.
     
  • Notice of Intent to Publish Funding Opportunity Announcements for the RADx®-UP Initiative (Phase III) – Due March 7
    The purpose of this NOSI is to explore novel interventions to increase access to and uptake of rapid SARS-CoV-2 testing (e.g., rapid antigen testing) in an environment of widespread vaccine availability; the social, ethical, and behavioral implications associated with testing; and specific strategies for scalable and sustainable testing programs to enable safe in-person school instruction. 
     
  • 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 (NOSI): Administrative Supplements and Urgent Competitive Revisions for Research on the 2019 Novel Coronavirus – Due March 31
    The purpose of this FOA is to highlight the urgent need for continued research on the impacts of SARS-CoV-2, the coronavirus that causes COVID-19.
 

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

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: 28

  • Administratively Not Supported: 17

  • Revise and Resubmit: 6

  • Withdrawn: 8

  • Liaisons: 1

  • EWGs: 3

  • Not Approved: 29

  • EMT: 5

  • Other: 7

EWG Assignment

  • COVID: 77

  • Respiratory: 10

  • Sexually Transmitted Infections: 5

  • Malaria and Tropical Dis.: 4

  • Enteric Inf.: 3

  • Emerging Infections: 5

ECP Status

  • Protocol Development: 5

  • Active Study: 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): 3

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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