Victory in the Battle against Brucella: From bench to battlefield

Let no one ever say that Allison Rice-Ficht, Ph.D. is anything short of tenacious. For years she has doggedly, tirelessly investigated some of the world’s most dangerous diseases and how to fight them in new and innovative ways.

Now, after six years of focused research, Rice-Ficht, director of the Center for Microencapsulation and Drug Delivery at the Texas A&M Health Science Center (TAMHSC), her co-principal investigators and team are nearing completion on the first human Brucella vaccine. Brucella bacteria cause brucellosis in both humans and animals. In humans, brucellosis is a chronic disease characterized by high fever and incapacitation of the infected individual for several days. Thereafter, it recurs periodically. If left untreated it can induce cardiovascular and osteoarticular diseases, and can cross the blood-brain barrier to cause neurological symptoms.

After 6 years of focused research, Dr. Allison Rice-Ficht is nearing completion on the first human Brucella vaccine.

After 6 years of focused research, Dr. Allison Rice-Ficht is nearing completion on the first human Brucella vaccine.

Because Brucella is considered a select agent by the Centers for Disease Control and Prevention, meaning that it is readily weaponized, the vaccine would be primarily used as a biodefense inoculation for military personnel. To develop a vaccine with military applications for humans, Rice-Ficht received a $2.6 million grant in 2007 from the Department of Defense (DOD), specifically the Military Infectious Disease Research Program, a part of the U.S. Army Medical Research and Material Command. Her co-principal investors on the DOD grant include her husband, Thomas Ficht, Ph.D., professor in the Department of Veterinary Pathobiology at Texas A&M University’s College of Veterinary Medicine and Biomedical Sciences, and James Samuel, Ph.D., chair of the TAMHSC College of Medicine Department of Microbial and Molecular Pathogenesis. Since 2007 the original grant has been renewed twice, once in 2009 and then again in 2011, for a total of an additional $1.6 million. It will conclude this December.

As an international expert on Brucella and its infection of animals, Ficht has focused his research on genetically incapacitating the agent, supported by the NIH via the Western Regional Center of Excellence at UTMB, while Rice-Ficht and her team have concentrated on an improved delivery system to make the vaccine stable at room temperature and to promote safe oral ingestion. She calls it a “pocket vaccine,” and it will allow military personnel to carry capsules in their pockets for oral consumption in crisis situations – akin to a stick of gum.

Before the pocket vaccine is ready for distribution, Rice-Ficht explained, an injectable form of the vaccine must precede the portable capsule version.

“We are now addressing packaging issues so that the future ‘pocket vaccine’ may be distributed at room temperature and without the assistance of medical personnel,” she said. “We must first make sure the injectable form is usable and effective.”

After more than 18 months, a patent application is now pending on the vaccine and vaccination studies in animal models are concluding. In recent animal studies, no side effects were detected, and the vaccine has even been successful in animal models that have been immunocompromised. Currently, under the DOD grant, the vaccine is being developed solely for human immunization, and Rice-Ficht hopes to have it in clinical human trials in the near future. It also shows promise for use in animals, primarily livestock like cattle and goats, which are among the most common carriers of brucellosis. Both Rice-Ficht and Ficht hope to maximize these animal-human parallels in support of Texas A&M’s One Health initiative.

When the vaccine is ready for production, and through a joint effort between Texas A&M University, Texas A&M Health Science Center and other collaborators, INCELL Corporation in San Antonio will provide pilot-scale manufacturing. Large-scale manufacturing may be performed in the future by the National Center for Therapeutics Manufacturing (NCTM), the first multidisciplinary workforce education institution and biopharmaceutical manufacturing center, at Texas A&M University.

“We see this large-scale production in the future with NCTM,” said Rice-Ficht. “Such collaboration maximizes the resources of the Texas A&M System.”

And even though one part of Rice-Ficht’s work may be coming to a close, she keeps an eye trained to the future. Since that initial grant in 2007 she has worked to leverage the DOD funding for additional aid, including a prestigious Gates Foundation grant for $100,000 in 2009 for a related research project. Additionally, Rice-Ficht’s and Samuel’s work will continue thanks to a Defense Threat Reduction Agency (DTRA) grant to Samuel. The DTRA grant will support the continued research of Q fever, a bacterial infection that humans acquire after contact with infected animals or exposure to contaminated environments. Without missing a beat, Rice-Ficht adds that she will continue to contribute to ongoing projects with U.S. Army Medical Research Institute of Infectious Diseases for controlled release viral vaccines.

Since 1984, Rice-Ficht has been a faculty member of the TAMHSC College of Medicine in the Department of Molecular and Cellular Medicine. In addition to being named a Texas A&M Regents Professor in 2005, Rice-Ficht currently serves as Associate Vice President of Research for the Texas A&M Health Science Center. 

 

Contributed by Lindsey Bertrand

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