Weekly Bulletin

Profile: Karla Mosby, RN, CCRC

Read an interview with Karla Mosby, RN, CCRC, VTEU Clinical Research Nurse Supervisor at Saint Louis University.

“Clinical research is essential to health promotion, disease prevention, and treatments. Study volunteers are vital to the success of our research, and it is always our priority to keep them fully informed and safe. We are also committed to including a diverse population in our clinical trials and continuously working to build greater trust in our community.” - Karla Mosby, RN, CCRC

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IDCRC Twitter Account

Follow @IDCRC_LG and join the conversation. View daily tweets sharing IDCRC news and supported work.

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In The News

NIH begins study of COVID-19 vaccination during pregnancy and postpartum

Published June 23, 2021

A new observational study has begun to evaluate the immune responses generated by COVID-19 vaccines administered to pregnant or postpartum people. Researchers will measure the development and durability of antibodies against SARS-CoV-2, the virus that causes COVID-19, in people vaccinated during pregnancy or the first two postpartum months. Researchers also will assess vaccine safety and evaluate the transfer of vaccine-induced antibodies to infants across the placenta and through breast milk.

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U.S. clinical trial results show Novavax vaccine is safe and prevents COVID-19

Published June 14, 2021

Results from a Phase 3 clinical trial enrolling 29,960 adult volunteers in the United States and Mexico show that the investigational vaccine known as NVX-CoV2373 demonstrated 90.4% efficacy in preventing symptomatic COVID-19 disease. The candidate showed 100% protection against moderate and severe disease. In people at high risk of developing complications from COVID-19 (people 65 years or older and people under age 65 with certain comorbidities or with likely regular exposure to COVID-19), the vaccine showed 91.0% efficacy in preventing symptomatic COVID-19 disease.

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NIH clinical trial evaluating mixed COVID-19 vaccine schedules begins

Published June 1, 2021

The National Institutes of Health has started a Phase 1/2 clinical trial in which adult volunteers who have been fully vaccinated against COVID-19 will receive booster doses of different COVID-19 vaccines to determine the safety and immunogenicity of mixed boosted regimens. 

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Emory’s Dr. David Stephens receives 2021 Health Care Heroes Lifetime Achievement Award

Published May 28, 2021

David S. Stephens, MD, IDCRC contact PI, LG chair, and chair of Emory University's Department of Medicine, is the recipient of the Atlanta Business Chronicle’s 2021 Health Care Heroes Lifetime Achievement Award. Click the button below to read a story on Stephens' exemplary career in health care and research. 

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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:

  • Pediatric COVID-19 Vaccine Clinical Trial Updates presented by Bob Frenck, MD
  • Bamlanivimab for Prevention of COVID-19
  • Effect of Bamlanivimab vs Placebo on Incidence of COVID-19 Among Residents and Staff of Skilled Nursing and Assisted Living Facilities: A Randomized Clinical Trial
  • Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents
 

Map: IDCRC Affiliated Sites Across the World

View an interactive map of the VTEU international sub sites on the IDCRC website.

VIEW WORLD MAP
 

Training

Mentoring Lecture Archive: Developing a Proposal: Statistics
Presenter: Dr. Elizabeth Brown, Fred Hutchinson Cancer Research Center

VIDEO ARCHIVE
 

IDCRC Studies

Active Studies
Recruiting Volunteers

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

  • 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

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
IDCRC ACTIVE AND COMPLETED STUDIES
 

IDCRC Concept Quick Stats

ICP Status

  • Approved: 21

  • Administratively Not Supported: 16

  • Revise and Resubmit: 10

  • Withdrawn: 6

  • Liaisons: 2

  • EWGs: 4

  • Not Approved: 25

  • EMT: 2

  • Other: 3

EWG Assignment

  • COVID: 67

  • Respiratory: 9

  • Sexually Transmitted Infections: 4

  • Malaria and Tropical Dis.: 3

  • Enteric Inf.: 2

  • Emerging Infections: 4

ECP Status

  • Protocol Development: 5

  • IDCRC Study Underway: 2

  • 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: 0

  • In process: 6

  • On hold: 3

NOTE: Protocols Transitioned to IDCRC for Protocol Implementation: 5

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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