Profile: IDCRC Research Coordinator Connie Rangel

IDCRC Box Migration to SharePoint Assistance

The IDCRC is now sharing files and resources on SharePoint. You have received an invitation to join the IDCRC SharePoint site. If you missed the email, you can still access the site here. It is strongly recommended that you bookmark this webpage for easy access in the future. As you have time, please access and peruse the site. This will be the primary repository for network materials for the IDCRC.

If you have questions, please reach out to one of the following people for assistance:

Training

New Investigator Pilot Awards – LOI Due June 7

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.

Mentoring Lecture Archive: Developing a Proposal: Study Design
Presenter: Dr. Hana El Sahly, Baylor College of Medicine

In The News

NIH closes enrollment in trial comparing COVID-19 treatment regimens

Published April 15, 2021

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, recently announced that the fourth iteration of the Adaptive COVID-19 Treatment Trial (ACTT-4) has closed to enrollment because the study met pre-defined futility criteria indicating that neither treatment regimen studied is likely significantly better than the other. The NIAID-sponsored trial aimed to determine which of two drug combinations—baricitinib plus remdesivir or dexamethasone plus remdesivir — was more effective at preventing adults hospitalized with COVID-19 on supplemental oxygen from progressing to requiring mechanical ventilation or death, among other outcomes.

COVID-19 vaccine trial volunteer on the shot heard ’round the world

Published April 2021

Jennifer Haller was not looking for the spotlight. A people operations manager for a small tech start-up in Seattle, she loved spending time at home with her 2 teenage children, escaping the city to hike in the Cascades, and fostering rescue dogs that had been nearing their final days at a shelter. Her life took an unexpected turn a year ago when she chose to participate in the first phase 1 clinical trial of a vaccine against COVID-19, taking place at Kaiser Permanente Washington Health Research Institute (KPWHRI). She received the first shot on the morning of March 16, 2020.

Second-generation COVID-19 vaccine clinical trial starts

Published April 7, 2021

UW Medicine investigators are starting volunteer enrollment for a clinical trial evaluating an investigational, second-generation COVID-19 vaccine. The Phase 1 multicenter study will examine safety, tolerability, and immune response for different doses of a two-part, investigational COVID-19 vaccine regimen. The second stage of the study will include vaccines with multiple SARS-CoV-2 proteins, in addition to the components of Spike protein used in the current COVID-19 vaccines given under FDA Emergency Use Authorization.

COVID-19 variant vaccine trial begins at KPWHRI and Emory

Published April 1, 2021

An investigational vaccine designed to protect against the coronavirus variant first detected in the Republic of South Africa was administered April 1 to 3 adult volunteers enrolled in a new phase 1 clinical trial at Kaiser Permanente Washington Health Research Institute (KPWHRI). The trial was officially launched the day before with shots being given at the Hope Clinic of Emory Vaccine Center.

NIH Clinical Trial Evaluating Moderna COVID-19 Variant Vaccine Begins

Published March 31, 2021

An investigational vaccine designed to protect against the B.1.351 SARS-CoV-2 variant has been administered as part of a new Phase 1 clinical trial evaluating the vaccine candidate’s safety and immunogenicity in adult volunteers. The vaccine, known as mRNA-1273.351, was developed by the biotechnology company ModernaTX, Inc., based in Cambridge, Massachusetts. The trial is led and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The trial will enroll approximately 210 healthy adult volunteers at four clinical research sites in the United States that are part of the NIAID-funded Infectious Diseases Clinical Research Consortium (IDCRC). 

Gritstone announces dosing of first subject in Covid-19 vaccine study

Published March 30, 2021

Gritstone Oncology has announced the dosing of the first subject in a Phase I study of its second-generation candidate Covid-19 vaccine, CORAL. The multi-centre, open-label, dose- and age-escalation study will assess the immunogenicity and safety of Gritstone’s CORAL Covid-19 vaccine in healthy adult subjects.

Publications

• Antibody Persistence through 6 Months after the Second Dose of mRNA-1273 Vaccine for Covid-19

• The need for inclusion of pregnant women in COVID-19 vaccine trials

• Infection- and vaccine- induced antibody binding and neutralization of the B.1.351 SARS-CoV-2 variant

• The SARS-CoV-2 mRNA-1273 vaccine elicits more RBD-focused neutralization, but with broader antibody binding within the RBD

IDCRC Studies

IDCRC Concept Quick Stats

Communication Resources

Please submit IDCRC news to epthomp@emory.edu for inclusion in the monthly newsletter and IDCRC.org.