Profile: IDCRC-VTEU Clinical Research Site Director

Michelle Dickey, MS, FNP-BC, PNP-BC, CCRC

"I view clinical research as an extension of good clinical care. Identifying gaps in clinical care and then asking and answering questions to improve clinical care is highly rewarding for both my personal growth as well as the health of the community. I very much enjoy the personal interaction with the individual patient and the effect I can have on their health. However, the conduct of research allows me to effect change literally throughout the world. I know that one day soon, I will be able to look back on 2020 and feel great pride about how the work we conducted as part of the VTEU was instrumental in quelling COVID-19 and allowing society to return to normal."

Training

IDCRC New Investigator Pilot Awards

The IDCRC New Investigator Pilot Awards will fund two $50,000 awards per year for research projects and career development activities that will enhance early stage investigators' ability to compete successfully for an independent R- or K-series award. Research projects can address a variety of topics, including vaccinology, therapeutics, laboratory studies, and statistics. We encourage but do not require projects that are value added to existing VTEU projects.

Key Dates

• Letter of Intent Due Date: December 9, 2020
  Submit Online
   
• NIA Application Due Date: February 1, 2021
  Submit Online
   
• Award Period Begins: March 15, 2021

In The News

NIH: "Fourth iteration of COVID-19 treatment trial underway"

Published November 25, 2020

The National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health, announced that the fourth iteration of the Adaptive COVID-19 Treatment Trial (ACTT-4) has begun to enroll hospitalized adults with coronavirus disease 2019 (COVID-19) who require supplemental oxygen. The NIAID-sponsored trial will enroll up to 1,500 patients at approximately 100 sites in the United States and other countries.

Participating IDCRC Sites

• Baylor College of Medicine VTEU and subsite University of Texas Medical Branch
• Emory University VTEU
• New York University VTEU
• Saint Louis University VTEU
• University of Alabama at Birmingham
• University of Maryland School of Medicine VTEU
• ​University of Rochester Medical Center VTEU

NIH: "Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine"

Published November 16, 2020

An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 15, 2020. This interim review of the data suggests that the vaccine is safe and effective at preventing symptomatic COVID-19 in adults. The interim analysis comprised 95 cases of symptomatic COVID-19 among volunteers. The DSMB reported that the candidate was safe and well-tolerated and noted a vaccine efficacy rate of 94.5%. The findings are statistically significant, meaning they are likely not due to chance. 90 of the cases occurred in the placebo group and 5 occurred in the vaccinated group. There were 11 cases of severe COVID-19 out of the 95 total, all of which occurred in the placebo group.

Participating IDCRC Sites

• Baylor College of Medicine VTEU and subsite University of Texas Medical Branch
• Emory University VTEU and subsite Emory Children’s Center Vaccine Research Center
• Kaiser Permanente Washington Health Research Institute VTEU
• Saint Louis University VTEU
• University of Maryland School of Medicine VTEU
• Vanderbilt University Medical Center VTEU and subsite University of Pittsburgh

AstraZeneca: "AZD1222 vaccine met primary efficacy endpoint in preventing COVID-19"

Published November 23, 2020

Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalizations or severe cases of the disease were reported in participants receiving the vaccine. There were a total of 131 COVID-19 cases in the interim analysis.

"Warp Speed Chief Visits Emory, Urges Participation in COVID Vaccine Trials"

Published November 13, 2020

On Thursday, November 12, Dr. Moncef Slaoui, chief scientific adviser for Operation Warp Speed, toured the Emory Children’s Center, where two leading COVID vaccine clinical trials are underway. 

During his tour, Slaoui thanked the researchers and staff working on the trials and offered any assistance to keep the work at Emory moving forward. He had special words of thanks for vaccine trial volunteers and encouraged more Americans to step forward if they are able.

"Fauci, Neuzil Address UAB at COVID-19 Research Symposium"

Published October 28, 2020

Anthony Fauci, MD, one of the lead members of the White House Coronavirus Task Force focusing on the COVID-19 pandemic in the United States, and Kathleen Neuzil, MD, one of the world’s most influential research scientists and advocates in vaccine development and policy, delivered keynote addresses to more than 2,000 trainees, faculty, staff and invited guests as part of the University of Alabama at Birmingham’s virtual COVID-19 Research Symposium. 

Publication

View a recent journal article featuring IDCRC-supported work below:

• Development of a Rapid Focus Reduction Neutralization Test Assay for Measuring SARS‐CoV‐2 Neutralizing Antibodies

IDCRC-CoVPN Studies

Events

Virtual IDCRC Annual Meeting
January 19 (10 a.m. - 4 p.m.) and January 21 (10 a.m. - noon), 2021

In planning the agenda for the Annual Meeting in January, it has been proposed that a second day be added for breakout reviews and discussion. This very important session on Day Two would only be a two-hour meeting from 10 a.m. to noon (EST).

IDCRC Concept Quick Stats

Communications Resources

Access IDCRC communications resources on Box or visit the web-based toolkit.