mRNA-1273 COVID-19 Vaccine Trial Goes to the Piney Woods of Mississippi Led by Hattiesburg Clinic

Jul 31, 2020 | COVID-19, Hattiesburg Clinic, Leading Sites, Mississippi, mRNA-1273, News, Site Success, Site Watch, Vaccine

mRNA-1273 COVID-19 Vaccine Trial Goes to the Piney Woods of Mississippi Led by Hattiesburg Clinic

Hattiesburg Clinic in Hattiesburg, Mississippi, was selected by Moderna as one of the 89 clinical investigational site for the pivotal Phase 3 vaccine trial evaluating mRNA-1273. Located in the Deep South in Mississippi’s “Pine Belt,” this medical center was selected for one of the most critical trials in U.S. history due to “the level of sophistication of the medial community” here, reports Dr. Rambod Rouhbakhsh, one of the study’s investigators. What is Hattiesburg Clinic? The TrialSite sought to learn more about this provider.

History

The provider that was to be Hattiesburg Clinic got its start back on May 1, 1963 and actually can trace its roots back to 1948 when Ramsay O’Neal, MD an OB-GYN and Glen T. Pearson, MD, a general surgeon became partners. Together, the providers envisioned something bigger that could impact the entire state. Now this has transformed into the largest multi-specialty clinic in the entire State of Mississippi. With over 300 physicians and providers caring for patients across 18 counties in South Mississippi, the center employs nearly 2,000 professional staff employees who strive to serve over 50,000 residents who live and work in South Mississippi.

Hattiesburg Clinic Medisync® Clinical Research

Hattiesburg Clinic’s research department is known as Hattiesburg Clinic Medisync® Clinical Research. A sophisticated operation, it actually packs a “double bunch” against the novel coronavirus as the clinic along with Forrest General Hospital joined two major programs including one targeting serious ill patients with COVID via the Mayo Clinic and the Moderna vaccine clinical trial along with the NIAD (part of NIH). Dr. John “Bo” Hrom, clinical trial director for oncology at both the Hattiesburg Clinic and Forrest Genera, leads the clinical program. Dr. Hrom reported recent to the Clarion Ledger, “This is kind of my wheelhouse,” commenting, “Since I set up and help run clinical trials, I basically have the experience to do it.” Meanwhile, of course, Dr. Rambod Rouhbakhsh leads the Phase 3 vaccine trial sponsored by Moderna alongside the NIAID.

COVID-19 Trial

Hattiesburg Clinic envisioned a more systematic and scalable operation and moved to execute on that imperative, reports Caroline Wood of WDAM 7. Since then, Dr. Rouhbakhsh reports that with investments in electronic medical records systems they now can find optimal matches for clinical trials and the approximately 100,000 people they serve or as the doctor stated, “allows us to identify patients very quickly.” Now all clinical trials include inclusion and exclusion criteria hence the EHR search function must support the ability to slice and dice patient attribute to preclude participants from a study as well.

Because of the technology and associated business processes, the culture and the number of specialist providers and patients the sponsor hope the Hattiesburg Clinic can enroll up to 400 participants for this study.

In terms of participation criteria, Dr. Rouhbakhsh notes they cannot include people that have had the illness. Because of so many asymptomatic cases, this can be tricky when recruiting participants.

Could a Vaccine be Ready by Jan 2021?

President Donald Trump declared that Operation Warp Speed would ensure a safe and effective vaccine by January 2021. And while this is technically possible actually executing on a successful vaccine will take time. Dr. Roubakhsh suggested that “If the preliminary results of these vaccine trials are so positive that the Institutional Review Board that oversees these…they say look the data is so compelling already that is now unethical to continue to have a placebo arm and you need to stop the trial and offer this therapy to everyone in the clinical trial.” Hence the doctor declared “that would be the only way that a massively available vaccine would come before the end of the two-year trial period.”

The Study

This study, sponsored by Moderna with collaborators National Institute of Allergy and Infectious Diseases (NIAID) and BARDA, is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to second years after the second dose of the mRNA-based investigational vaccine.

Lead Research/Investigator

Rambod Rouhbakhsh, MD 

John “Bo” Hrom, MD, clinical trial director for oncology

Call to Action: Are you based in the Mississippi Pine Belt? If so, and if you fit the inclusion criteria, consider participation in this critically important clinical trial.

Source: WDAM7

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