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Forty Years of Fortitude: Dr. James Dale’s Journey to Develop a Life-Saving Strep Vaccine

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With a vaccine that could save half a million lives yearly, James B. Dale, MD, is the kind of innovator worth celebrating.

When the phone call came, Dr. James Dale’s first thought wasn’t gratitude or pride. It was confusion.

“Why in the world are they giving this award to me?” the professor emeritus recalled thinking. “Where are all the young, innovative people?”

Yet after four decades of research on a vaccine that could save nearly half a million lives each year, James B. Dale, MD, is exactly the kind of innovator the University of Tennessee Research Foundation wanted to celebrate. On Dec. 10, he received the UTRF Innovator of the Year award on campus in Memphis, recognition for a career defined not by quick wins, but by enduring dedication.

The honor comes not at the end of Dr. Dale’s story, but during a pivotal time when years of groundwork are gaining global momentum.

“The end of the story isn’t a particular celebration because we’re not at the end,” Dr. Dale said. “We don’t have a huge license deal. We don’t have a vaccine that’s going into thousands of kids yet. But on the other hand, I’ve been around the university a long time. I’ve been through trials and tribulations. Maybe it’ll inspire young people to have the patience, persistence, and inspiration to have a good idea and stick with it. That’s what we’ve done.”

Todd Ponzio, vice president of UTRF, said Dr. Dale’s work represents the highest ideal of the physician-scientist.

“Taking a problem from the bedside, solving it at the bench, and driving it back to the clinic. His relentless pursuit of a Strep A vaccine has positioned UTHSC at the forefront of global infectious disease research, and we’re incredibly proud to name him our Innovator of the Year.”

A Career Built on Perseverance

Dr. Dale’s relationship with UT Health Sciences spans more than 40 years. After earning his undergraduate degree from UT Knoxville in 1977 and completing his medical training at UT Health Sciences in Memphis, he joined the faculty in 1983. He’s served as chief of the Division of Infectious Diseases for more than 30 years while simultaneously holding leadership positions at the Lt. Col. Luke Weathers, Jr. Veterans Affairs Medical Center, including associate chief of staff for education for nearly 18 years.

His work focuses on developing vaccines against Group A streptococcus, a bacterial infection that causes more than just strep throat. In low and middle-income countries, the infection can lead to rheumatic heart disease, which kills nearly half a million people every year.

“It’s a significant disease burden not particularly recognized in high-income countries, because the incidence of the disease has dropped significantly since World War II,” he said. “The decline in wealthy nations has made vaccine development less attractive to major pharmaceutical companies despite the devastating global impact.”

Technology Catches Up to Vision

Dr. Dale’s lab has secured partnerships and funding to continue to propel his strep vaccine work.

Dr. Dale’s career illustrates how scientific progress sometimes requires waiting for technology to evolve. His team knew how to conceptualize these vaccines years ago, but the tools to manufacture them at reasonable cost and speed didn’t exist.

“We really needed to wait for technology to catch up with our ideas,” he said. “We were reliant upon synthetic peptides early on, but as a vaccine basis, they were too expensive and really not feasible.”

The breakthrough came with advances in DNA sequencing and recombinant protein technology in the 1990s, which allowed his team to create highly complex vaccines. More recently, mRNA technology has revolutionized their work entirely.

Collaborating with pharmaceutical company Moderna over the past several years, Dr. Dale’s team demonstrated mRNA vaccines could be effective against bacterial diseases, not only viral infections. Where protein-based vaccines took more than a year to manufacture and formulate for clinical trials, Moderna produced mRNA versions within weeks of receiving the amino acid sequences.

These vaccines work by using a piece of messenger RNA (mRNA) to instruct cells to make a harmless protein of a specific virus or bacterium, training the immune system to recognize and fight the actual infection if exposed in the future. Unlike traditional vaccines, they don’t expose you to the infecting agent itself and don’t affect your DNA.

“I believe mRNA vaccines are the future, particularly for organisms that may have multiple different protective antigens or viruses that change from year to year like the flu and COVID,” Dr. Dale said.

Global Recognition and New Partnerships

The tide began turning in the past five years. After years of Dr. Dale’s team reaching out to potential partners, companies and foundations started coming to them.

“When you have a reputation, both nationally and internationally, in the strep vaccine field, and somebody’s interested in developing strep vaccines, they look at the literature, and they look at who’s out there,” he said. “Our lab has been leading for decades. So they call us.”

Moderna approached Dr. Dale’s team, followed by the Leducq Foundation, an international organization focused on cardiovascular disease that recently expanded its mission to include rheumatic heart disease prevention. The foundation has funded Dr. Dale’s research for the past year and a half.

The World Health Organization and World Health Assembly have also taken notice, raising awareness about the global impact of strep A infections on children and young adults.

Dr. Dale’s team has completed four early-stage clinical trials on three different vaccines. At one point, they even started their own company, Vaxent, hoping clinical data would attract vaccine manufacturers. When funding ran out and licensing deals didn’t materialize, the company closed. But the research continued.

The Road Ahead

Today, Dr. Dale’s laboratory team has narrowed from five or six researchers to two, focusing specifically on vaccine development rather than broader pathogenesis research. The work moves forward every day with support from both Moderna, which manufactures the vaccines, and the Leducq Foundation, which is providing research funding.

Additionally, this year marks a defining moment for the university, earning R1 status from the Carnegie Classification of Institutions of Higher Education. This achievement places UT Health Sciences among the top 5% of research universities nationwide.

“Commercializing academic research is a marathon, not a sprint,” Ponzio said. “Jim Dale didn’t just discover the vaccine candidate; he built the business infrastructure, founded Vaxent, and navigated complex regulatory landscapes to get this technology into clinical trials. He’s done the heavy lifting to pave the way for a solution that can eventually reach patients who need it most.”

Despite the recognition, Dr. Dale remains focused on the effort ahead. His doggedness offers a lesson for younger researchers entering fields where breakthroughs can take a lifetime or more.

“It’s an honor to be recognized,” he said. “I’ve been around a long time, and that’s okay.”