Profile: University of Rochester Vaccine and Treatment Evaluation Unit

“As a network of investigators, many of whom are also practicing physicians, we are deeply embedded in our local communities and committed to improving health care. This allows us to identify the most important health care issues that need to be addressed locally, nationally, and in the world." - Angela Branch, MD

Pictured above: Angela Branche, MD and Ann Falsey, MD, University of Rochester Vaccine and Treatment Evaluation Unit co-PIs

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: Development, Licensure, and Emergency Use Authorization of Preventive Vaccines – Regulatory Considerations
Presenter: Dr. Doran Fink, FDA/CBER

In The News

IDCRC launches COVID-19 vaccine trial for young children

Published May 2021

Researchers from Infectious Diseases Clinical Research Consortium (IDCRC) sites across the country are participating in a clinical trial testing Moderna’s COVID-19 vaccine in children ages six months to less than 12 years.

This is the same Moderna mRNA-1273 vaccine that is being distributed nationwide for adults following an emergency use authorization from the U.S. Food and Drug Administration in December. The initial phase of the KidCOVE study will test different doses of the vaccine to evaluate safety in a younger population.

IDCRC studies COVID-19 vaccines during pregnancy and postpartum, the MOMI-Vax Study

Published May 2021

Infectious Diseases Clinical Research Consortium (IDCRC) researchers at sites across the country are conducting a clinical study of immune responses to various COVID-19 vaccines when administered to people during or just after pregnancy.

The observational, non-interventional study will evaluate the safety and immune responses created by various COVID-19 vaccines when administered to pregnant or postpartum individuals. These vaccines were granted emergency use authorization from the U.S. Food and Drug Administration and provide protection against the SARS-CoV-2 virus in adults. The study will also assess how vaccine-induced antibodies transfer to infants through breast milk and the placenta.

IDCRC researchers are exploring the possible benefits of pairing doses from two different COVID-19 vaccines

Published May 2021

Researchers from Infectious Diseases Clinical Research Consortium (IDCRC) sites across the country are conducting a clinical trial to assess the use of booster doses of the Moderna-mRNA-1273 COVID-19 vaccine to determine the safety and effects of a mix and match booster on a person’s immunity to SARS-CoV-2, the virus that causes COVID-19.

The study will include two groups: persons who have already received any FDA emergency use authorized (EUA) COVID-19 vaccine and persons who have never received a COVID-19 vaccine and have not had a prior SARS-CoV-2 infection. Study participants will receive a delayed booster vaccine of Moderna-mRNA-1273, regardless of which COVID-19 vaccine was first administered - creating a mix and match booster.

Second-generation COVID-19 vaccine clinical trial starts at Baylor College of Medicine

Published May 26, 2021

Baylor College of Medicine investigators are recruiting volunteers for a multicenter Phase 1 clinical trial to examine the safety, tolerability and immune response for different doses of a two-part, investigational COVID-19 vaccine regimen.

Nadine Rouphael, MD, receives Dragon Award from Emory's Office of Research Administration

Published April 30, 2021

Nadine Rouphael, MD, professor in Emory's Division of Infectious Diseases, is the recipient of the Faculty Dragon Award from Emory’s Office of Research Administration (ORA). The Faculty Dragon category is a special nomination by ORA and Research Administration Services (RAS) staff for a faculty member who consistently demonstrates an exceptional partnership with ORA. Rouphael was presented the award at the ORA Town Hall April 15, 2021.

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:

• Evaluation of Cellular and Serological Responses to Acute SARS-CoV-2 Infection Demonstrates the Functional Importance of the Receptor-Binding Domain
• The SARS-CoV-2 mRNA-1273 vaccine elicits more RBD-focused neutralization, but with broader antibody binding within the RBD
• The need for inclusion of pregnant women in COVID-19 vaccine trials
• Reduced binding and neutralization of infection- and vaccine-induced antibodies to the B.1.351 (South African) SARS-CoV-2 variant
• COVID-19 and the Path to Immunity
• Accounting for informative sampling in estimation of associations between sexually transmitted infections and hormonal contraceptive methods

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.