Piedmont Healthcare & Moderna Lead the World in Opening Up First Clinical Trial Evaluating mRNA-based COVID-19 Vaccine in Transplant or Immunocompromised Patients

Piedmont Healthcare & Moderna Lead the World in Opening Up First Clinical Trial Evaluating mRNA-based COVID-19 Vaccine in Transplant or Immunocompromised Patients

Recently, TrialSite mentioned the importance of new research testing to determine the efficacy of Moderna’s mRNA-1273 COVID-19 vaccine for liver and other transplantation patients. TrialSite’s founder Daniel O’Connor was able to connect with Dr. Raymond A. Rubin, Chief Scientific Officer for Piedmont Transplant Institute. One of the busiest organ transplant centers in the United States, Piedmont Healthcare was selected by Moderna to conducted a clinical trial evaluating the safety, reactogenicity and immunogenicity of the mRNA-based COVID-19 vaccine in adults with kidney or liver transplant as well as a control group of healthy participants. Currently, Piedmont Healthcare is the only TrialSite active in the United States for this mission-critical study deemed necessary by the European Medicines Agency as part of the authorization of the vaccine. A highly vulnerable group, transplant patients face higher risks than much of the population for SARS-CoV-2 infection. But the first COVID-19 vaccine trials precluded this population. As it turns out, some studies show that due to a confluence of factors, the COVID-19 vaccinations may not be as effective in this vulnerable population and given the number of transplants Piedmont Healthcare conducted annually, the importance of this study and this Atlanta-based healthcare center cannot be underestimated.

Announced recently by the leading Atlanta, Georgia-based healthcare system, Piedmont Health’s Piedmont Atlanta Hospital was the first trial site to enroll participants for Moderna’s COVE Transplant clinical trial, which will study the sponsor’s COVID-19 vaccine on liver or kidney transplant recipients.  

A Vulnerable Patient Category

Those individuals that receive transplants, from liver to kidney and even in some cases heart transplants, face considerable risks from the coronavirus pathogen, reported by Dr. Raymond Rubin to TrialSite’s founder. About 30,000 Americans get a transplant each year, about 7,000 of these representing actual liver transplants. At least 100,0000 to 110,000 wait on transplant lists. 

Dr. Rubin shared with TrialSite that compounding risk for many patients is the fact that many of them face other risk factors, such as comorbidities (e.g. diabetes, etc.); and at Piedmont, many of the kidney transplants are African American, who have fared worse during the pandemic based on infection, hospitalization and death rates.

In fact, Piedmont Healthcare reports that of all the kidney transplant patients at Georgia-based healthcare system, 48% are African American. When it comes to liver transplants, African Americans make up about 14% of all procedures.

A study sponsored by Johns Hopkins recently revealed that after one dose of a COVID-19 vaccine that organ transplant patients, as well as other immunocompromised people, may not produce sufficient levels of antibodies against SARS-CoV-2, the virus behind COVID-19. This represents a high risk for this patient class as their immune systems are already down, and it may be that they require additional vaccine doses or other adjustments.

The researchers found that after the first jab, only 17% of the 436 participants had any detectable antibodies to SARS-CoV-2, a problematically low number, which can be reviewed in the research letter published in JAMA

Vaccine Education Needs more Granularity

While Piedmont Healthcare‘s Transplantation Institute performs more transplants than most in American in terms of volumes of surgeries, a growing number of transplant patients may be feeling concerned about the COVID-19 vaccines, suggests Dr. Rubin.

But Dr. Rubin emphasized the risks associated with not getting a COVID-19 vaccine. In fact, he shared that a large percentage of their patients are elderly, just adding to the severe risk associated with a transplant patient’s exposure to COVID-19. Dr. Rubin informed TrialSite’s O’Connor that the risks of not getting vaccinated for this group are far higher than getting the vaccine. Rubin shared that while a lot of government funds are going into various community healthcare educational campaigns, such medical and research information must become ever more granular, specialized, and tailored to specific populations, such as the tens of thousands of transplant patients.

The Study

Dr. Rubin is the only principal investigator active in the United States thus far in this Moderna-sponsored Phase 3 clinical trial titled “A Phase 3b, Open-Label, Safety and Immunogenicity Study for SARS-CoV-2 mRNA-1273 Vaccine in Adult Solid Organ Transplant Recipients and Healthy Controls” (NCT04860297) that is currently listed at both Piedmont Healthcare and the University of Washington Medical Center. Again, a few other trial sites will be activated at primary academic medical centers.

Sponsored by Moderna (the only sponsor taking on this important research question at this point), the study started last month and thus far has enrolled 8 transplant subjects and 2 controls. A few more centers will open up, and the total subject target is 220 with 20 healthy volunteers serving as a control group. 

A critically important study that’s also been required by regulators in Europe, the trial probes to determine the immunogenicity and safety of the mRNA-1273 product in transplant patients. A number of primary and secondary endpoints can be reviewed here

Recruiting Participants & Highly Vulnerable Groups

Finding, enrolling, and retaining study subjects is often a challenge and in this case, with such a vulnerable population, it’s perhaps even more difficult. Dr. Rubin noted that, across sites, recruitment of subjects for vaccine studies becomes more challenging and that here at Piedmont Healthcare the study team uses the internal electronic health record system and associated outreach, outreach during care interactions and various messaging to the local press. For example, Piedmont Healthcare also may support local chapters of patient advocacy groups such as the American Society of transplants.

But Rubin emphasized the need for more granular, tailored healthcare education to at risk, highly vulnerable groups such as transplant patients. Without vaccines, all things being equal, such patients face far higher risks associated with failure to get vaccinated.   

And this study is so important on a number of fronts, reports Rubin. Noting that “we need to understand how to protect this class of patient from COVID-19 and that necessitates participation in this study to help us systematically and methodically understand how the vaccine dose may need to be modified,” Dr. Rubin runs a major clinic, caring for many hundreds of transplant patients while serving as a nationally preeminent principal investigator. 

Lead Research/Investigator

Raymond A. Rubin, MD, Chief Scientific Officer for Chief Scientific Officer for Piedmont Transplant Institute

Profile: Raymond Rubin, M.D., has returned to Piedmont to become the Chief Scientific Officer and as a general and transplant hepatologist at Piedmont Transplant Institute. During his time at Piedmont from 1996-2011, he co-founded and served as the medical director of Piedmont’s new liver transplant program (2004). From 2011 until 2014, Dr. Rubin left Atlanta for Boston to become a Medical Director at Vertex Pharmaceuticals, where he conducted research and evaluated new treatments for hepatitis C, other liver diseases, and inflammatory bowel disease. Dr. Rubin earned his medical degree from Cornell Medical College in New York, N.Y. He completed his residency in internal medicine and his fellowship in gastroenterology and hepatology at the Hospital of the University of Pennsylvania. Dr. Rubin graduated summa cum laude with bachelors in molecular and cellular biology and British literature. Dr. Rubin has been practicing medicine for 28 years. He is board certified in gastroenterology, internal medicine and transplant hepatology, and is a fellow of the American Association for the Study of Liver Diseases and of the American Gastroenterological Association. Rubin welcomes new patients and accepts most insurance plans.

About Piedmont Transplant Institute

Piedmont Transplant Institute is a proven, experienced leader in conducting transplant surgeries. Since 1986, Piedmont Transplant has been recognized as one of the nation’s most successful transplant programs, performing over 3,200 surgeries for liver, pancreas, kidney and heart recipients.

Call to Action: If you have a loved one in the Atlanta area that’s had an organ transplant and hasn’t received a vaccination yet, support them by reminding them of the dangers associated with COVID-19 and transplant surgery with no vaccination. If they have had a vaccination, consider discussing with them the importance of trial participation. This is literally the only major trial that’s seeking to better understand how to protect this patient class.