Deborah Dyer, RN, BSN, founded a clinical investigational site in Kentucky known as Central Kentucky Research Associates (CKRA) along with the late Jacqueline Smith, RN, BSN. CKRA was Kentucky’s first independent clinical research facilities and one of the few owned and operated by a women. Now part of a nationwide clinical research site operation called Alliance for Multispecialty Research (AMR), her Lexington, Kentucky office now participates in a critically important COVID-19 vaccine clinical involving Inovio Pharmaceutical’s INO-4800. For principal investigator Dr. Mark Adam, this represents an exciting opportunity to participate in a vaccine study with global imperative; for Lexington, Kentucky residents, this is an opportunity to step up and make a difference in the war against COVID-19.
Inovio Pharmaceuticals is based in Pennsylvania and as TrialSite News has suggested, could be the dark horse in the race to produce a COVID-19 vaccine candidate that is both safe and efficacious. A DNA-based vaccine that essentially tricks the body into thinking it is being invaded by SARS-CoV-2, has raised $9 million from the Coalition for Epidemic Preparedness Innovations (CEPI) as well as $5 million from the Bill & Melinda Gates Foundation. To learn more about how the INO-4800 vaccine is delivered, see this video.
The open-label study involves up to 40 participants to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device in healthy adult volunteers. The study started in April and runs ongoing through April 2021.
The Clinical Investigational Sites
The first participants for this vaccine trial were recruited at the University of Pennsylvania and the Center for Pharmaceutical Research, part of AMR (Alliance for Multispecialty Research). AMR represents a sort of a roll-up of clinical investigational sites across the country. With 17 highly experienced clinical research centers, they have enrolled over 145,000 subjects and completed over 9,500 Phase I-IV clinical trials across a broad range of therapeutic areas.
AMR Kansas City was the first office to be involved with the INO-4800 vaccine study targeting COVID-19.
AMR Lexington, Kentucky Now Testing INO-4800
Now most recently, WYMT local television showcased the COVID-19 vaccine trial coming to Lexington, Kentucky, where AMR’s Kentucky branch, AMR Lexington, is now recruiting participants.
Deborah Dyer, RN, BSN founded a clinical investigational site in Kentucky known as Central Kentucky Research Associates (CKRA) along with the late Jacqueline Smith, RN, BSN. CKRA, happened to have been Kentucky’s first independent clinical research facilities and one of the few owned and operated by a women.
Now part of Alliance for Multispecialty Research (AMR), the Lexington office will participate in a COVID-19 vaccine clinical trial AMR already has sites involved with—Inovio Pharmaceutical’s INO-4800.
Led by principal investigator Mark Adam, MD, he considered the possibility of working a vaccine at some point. After all, Dr. Adam has been studying vaccines for many years and now his team must actually ready to conduct perhaps the most critical vaccine in America in the modern era. A couple months ago, AMR mentioned to the Lexington team that they might participate but that became a reality two weeks ago. The overall vaccine trial, like all of them during the pandemic crisis, has been fast tracked—these studies usually take many years.
Hence the AMR Lexington team, formerly known as Central Kentucky Research Associates, commenced training for the new vaccine, learning new techniques for the administration of INO-4800.
Hence, residents in this part of Kentucky that want to contribute to the war against COVID-19 might consider participating in this clinical trial. Starting next week AMR Lexington starts enrolling participants for the vaccine test. During the process participants will maintain diaries so they can document day-to-day feeling and of course the big hope is that it goes well for all of the participants.
As Dr. Adam reports given the expedited nature of the study: “We are, if you think about it you’re looking at the first quarter of next year perhaps maybe the second quarter.”
About AMR Lexington
AMR Lexington also known as AMR Central Kentucky Research Associates in Lexington, Kentucky has conducted 608 Phase I–IV trials since opening in 1991. The Lexington location was Kentucky’s first independent clinical drug research facility. This location is housed in a 17,000 square foot facility that contains both an outpatient Phase II-IV clinic and an inpatient 23-bed Phase I and overnight unit. The location has five full-time clinical research coordinators, who average over 17 years of clinical research experience. The center also employs five full-time coordinator assistants and three full-time recruitment specialists. The clinic and recruitment staff are supported by a strong team of professionals who assist with regulatory, operations, data management, and quality assurance. The location has a diverse pool of 24 trained PRN employees who can be called upon to assist in the conduct of overnight and Phase I trials. Staff at the Lexington location have over 75 years of combined clinical research experience.
Call to Action: AMR Lexington is seeking healthy patients to participate in this important COVID-19 vaccine clinical trial. If you are based in this area, call AMR at 859-264-8999.