Weekly Bulletin

Profile: Investigator

Hana M. El Sahly, MD

Hana M. El Sahly, MD is an associate professor of molecular virology and microbiology at Baylor College of Medicine. She serves as the PI for the Baylor College of Medicine Vaccine and Treatment Evaluation Unit (VTEU) and on the Coronavirus and Respiratory Infections IDCRC Expert Working Groups.

"An IDCRC achievement that goes beyond this pandemic is the ability to launch non-COVID-19 expert working groups and projects. These will set the stage for the clinical research agenda for 2021 and beyond."

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Map: IDCRC Sites Across the Nation

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Introducing the IDCRC’s inaugural External Advisory Board

Katherine Poehling, MD, MPH
Professor of Pediatrics and Epidemiology and Prevention
Wake Forest School of Medicine
Director of Pediatric Population Health

Peter Dull, MD 
Deputy Director
Integrated Clinical Vaccine Development
Vaccine Development and Surveillance
Global Health Division, Bill & Melinda Gates Foundation

Ruth Lynfield, MD
State Epidemiologist, Medical Director
Minnesota Department of Health

Sharon Nachman, MD
Professor of Pediatrics
Associate Dean for Research
SUNY Stony Brook

Anne Drapkin Lyerly, MD, MA  
Professor of Social Medicine
Associate Director, Center for Bioethics
University of North Carolina, Chapel Hill

Penny Heaton, MD
Chief Executive Officer
Bill & Melinda Gates Medical Research Institute – US

Andrew J. Pollard, PhD 
Professor of Pediatric Infection and Immunity,
University of Oxford;
Honorary Consultant Pediatrician,
Oxford Children’s Hospital;
Vice Master of St. Cross College, Oxford

Stephanie Taylor, MD
Professor of Medicine and Microbiology
Section of Infectious Disease
Clinic Administrator and Medical Director
LSU-CrescentCare Sexual Health Center

Phyllis Arthur, MBA
Vice President
Infectious Diseases and Diagnostics Policy
Biotechnology Innovation Organization (BIO)

William John Moss, MD
Executive Director, International Vaccine Access Center
Professor, Epidemiology
Johns Hopkins Bloomberg School of Public Health

Joseph Eron, MD
Professor of Medicine and Chief,
Division of Infectious Diseases; 
Director, Clinical Core, UNC Center for AIDS Research Associate Director, General Clinical Research Unit
University of North Carolina School of Medicine

Training

Mentoring Lecture Series Video Archive

The IDCRC Mentoring Lecture Series brings the IDCRC mentees together with leading experts to discuss topics related to the VTEUs, vaccinology, and clinical trials development and management.

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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:

  • Protocol Development and Review
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In The News

2021 Research!America Advocacy Awards | April 14

Honoring Anthony Fauci, MD; Moncef Slaoui, PhD; Anne Schuchat, MD; NIAID; Moderna; and others

The 2021 event will mark the 25th anniversary of the Research!America Advocacy Awards and offers an unprecedented opportunity at an unprecedented time to acknowledge and honor the powerful research and innovation deployed in the fight against COVID-19. 

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Moderna Announces it has Shipped Variant-Specific Vaccine Candidate, mRNA-1273.351, to NIH for Clinical Study

Published February 24, 2021

Moderna, Inc. has completed manufacturing of clinical trial material for its variant-specific vaccine candidate, mRNA-1273.351, against the SARS-CoV-2 variant known as B.1.351 first identified in the Republic of South Africa, and has shipped doses to the National Institutes of Health (NIH) for a Phase 1 clinical trial that will be led and funded by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). 

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"Rouphael appointed Hope Clinic executive director"

Published February 15, 2021

Nadine Rouphael, MD, MSc, professor of medicine in the Division of Infectious Disease at Emory University School of Medicine, has been named executive director of the Hope Clinic, the clinical research arm of the Emory VTEU.

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"Analysis Demonstrates Effectiveness of LY-CoV555 Antibody in Preventing Symptomatic COVID-19"

Published February 1, 2021

Researchers from the COVID-19 Prevention Network (CoVPN) announced that the monoclonal antibody (mAb), LY-CoV555 (bamlanivimab), evaluated in a Phase III trial significantly reduces the risk of contracting symptomatic COVID-19 as well as reduces the clinical course of COVID-19 in study participants who did become symptomatic. The study, CoVPN 3501, was conducted in collaboration with Eli Lilly and Company, in skilled nursing facilities (SNFs) across the United States.

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"Janssen Investigational COVID-19 Vaccine: Interim Analysis of Phase 3 Clinical Data Released"

Published January 29, 2021

An investigational COVID-19 vaccine developed by Janssen Pharmaceuticals appears to be safe and effective at preventing moderate and severe COVID-19 in adults, according to an interim analysis of Phase 3 clinical data conducted Jan. 21. The vaccine, called Ad.26.COV2.S or JNJ-78436725, requires only a single injection and can be stored in a refrigerator for months.

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"Nanoparticles: The Next Generation of Vaccine Technology"

Published January 19, 2021

Arguably, the mRNA technology used to develop vaccines against COVID-19 by BioNTech-Pfizer and Moderna, are the next generation of vaccines. They have demonstrated their ability to be quickly developed and their efficacy. But researchers are working on yet another type of vaccine technology using nanoparticles that are less expensive than the mRNA vaccines and do not need to be stored at very low temperatures, as the current mRNA vaccines do.

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Publications and Presentations of Interest

  • Reduced binding and neutralization of infection- and vaccine-induced antibodies to the B.1.351 (South African) SARS-CoV-2 variant
  • Infection and mRNA-1273 vaccine antibodies neutralize SARS-CoV-2 UK variant
  • This COVID-vaccine designer is tackling vaccine hesitancy — in churches and on Twitter
  • COVID-19 Vaccines for Children, CDC Advisory Committee on Immunization Practices (ACIP) presentation | January 27, 2021
  • More than medical mistrust
 

IDCRC-CoVPN Studies

Active Studies
Recruiting Volunteers

  • Adaptive COVID-19 Treatment Trial 4 (ACTT-4)
     

  • Eli Lilly’s LY3819253 Antibody, the BLAZE-2 Study
     

  • SARS-CoV-2/COVID-19 PREVALENCE STUDY, The COMPASS Study

Fully Enrolled Studies
in Follow-up

  • Moderna’s mRNA-1273 vaccine, The COVE Study™
     

  • 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
IDCRC ACTIVE AND COMPLETED STUDIES
 

IDCRC Concept Quick Stats

ICP Status

  • Approved: 18

  • Administratively Not Supported: 16

  • Revise and Resubmit: 6

  • Withdrawn: 6

  • Liaisons: 1

  • EWGs: 3

  • Not Approved: 24

  • EMT: 0

  • Other: 3

EWG Assignment

  • COVID: 62
  • Respiratory: 8
  • Sexually Transmitted Infections: 2
  • Malaria and Tropical Dis.: 3
  • Enteric Inf.: 0
  • Emerging Infections: 2

ECP Status

  • Protocol Development: 6

  • Submitted to ACTIV Mab Program per DMID: 1

  • Transitioned to CoVPN trial: 1

  • Transitioned to ACTT 2: 1

  • Funded by NIAID via other mechanism: 1

  • Pending: 4

  • Not approved: 1

  • In process: 2 

  • On hold: 3

NOTE: Protocols Transitioned to IDCRC for Protocol Implementation: 5

IDCRC STUDIES
 

Communication Resources

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COMMUNICATION TOOLKIT
 

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