Emory University’s COVID-19 clinical trial assessing the potential of the Moderna’s mRNA-1273 vaccine is completely full. Seventeen participants joined the Atlanta part of the clinical trial—overseen my Emory’s Vaccine and Treatment Evaluation Unit (VTEU), reports a spokesperson. This represents good news.
The Phase I study sponsors—the National Institute of Allergy and Infectious Diseases—along with Moderna report that the study, which began on March 16 at the VTEU at the Kaiser Permanente Washington Health Research Institute in Seattle, is assessing the safety and whether the vaccine stimulates the immune system. The trial was targeted to enroll 45 participants across two sites: one at Seattle and the other at Atlanta, reports The Atlanta Business Chronicle.
The study is a Phase I open-label, dose-ranging clinical trial with both males and females. The clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273 manufactured by ModernaTx Inc.
The participants receive an intramuscular (IM) injection of mRNA-1273 on Days 1 and 29 in the deltoid muscle. The subjects are followed through 12 months post second vaccine (Day 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 3 dosages in healthy adults.
Known as mRNA-1273, the vaccine is based on messenger RNA, which guides some cells in the body to produce a viral protein. This RNA-based approach supports an accelerate vaccine development timeline as compared to older methods.
Emory Principal Investigators
Dr. Evan Anderson, associate professor of medicine and pediatrics, Emory University School of Medicine and Children’s Healthcare of Atlanta
Dr. Nadine Rouphael, Emory VTEU, contact principal investigator, interim director of the Hope Clinic of the Emory Vaccine Center; associate professor of medicine (infectious disease) at Emory University School of Medicine
Call to Action: With Emory’s Phase I study filled, TrialSite News will monitor carefully for any updates from the university.Source: Atlanta Business Chronicle