The FDA's Karen Elkins: An Ounce of Prevention (By a Vaccine) is Worth a Pound of Cure (of a Terrible Infection)

The ‘Nifty Fifty (times 4)’, a program of Science Spark, presented by InfoComm International, are a group of 200 noted science and engineering professionals who will fan out across the Washington, D.C. area in the 2014-2015 school year to speak about their work and careers at various middle and high schools.

Meet Nifty Fifty Speaker Karen Elkins

Karen Elkins_2015 Nifty Fifty SpeakerVaccines against diseases such as measles, polio, and whooping cough have greatly reduced deaths and suffering. These vaccines are designed to mimic the microbes that cause the disease. When given a vaccine, the body's immune system is inspired to ramp up and fight back against that microbe. As a result, immune defenders are ready and waiting when the real thing later starts an infection.

Better vaccines against many diseases are still needed, however. Most vaccines used today work by stimulating the body's immune system to make antibodies, which are proteins that bind microbes and start a process that eliminates them. But some microbes evade antibodies by hiding out within a person's cells. Diseases caused by microbes like these, such as tuberculosis, have been especially hard to combat.

Karen Elkins, an international expert in infectious disease immunology, is at the forefront of researching how the body's immune system protects against disease-causing bacteria that live within other cells. Knowledge about that, in turn, helps suggest better ways to design and test new vaccines.

She and her research team carry out their studies at the U.S. Food and Drug Administration (FDA), where she serves as Senior Investigator and Supervisory Research Biologist at the Center for Biologics Evaluation and Research (CBER). FDA ensures the safety and effectiveness of medical products, including vaccines. Research is fundamental to FDA's ability to evaluate vaccines, and the research that FDA conducts provides a strong science base. As a working infectious disease expert at FDA, Karen also evaluates new vaccines to determine whether they should be approved for general use.

To study immunity, Karen focuses on two disease-causing intracellular bacteria: Mycobacterium tuberculosis, which causes tuberculosis; and Francisella tularensis, which causes tularemia (commonly called "rabbit fever"). Instead of antibodies, cells called T lymphocytes are the prime defenders against these kinds of intracellular microbes. The ways in which T cells work are only partly understood.

"Tuberculosis damages the lungs, making it hard to breathe," Karen explains, "and people with tularemia have symptoms like high fever, fatigue, swollen lymph nodes, and pneumonia." Tularemia itself is a relatively rare disease. Nonetheless, because the live vaccine strain of Francisella tularensis has a number of convenient properties, her laboratory pioneered the use of this bacterium as research model. The team has used it to discover new mechanisms that T cells use to control all types of intracellular bacteria.

Other challenges in developing new vaccines come from the fact that the same microbe can enter the body by different routes. Karen points out, "Some vaccines protect against exposure to infection that starts in the skin, but are not as effective against inhaled bacteria. The reasons for these differences are also not well understood."

Equally important, she says, researchers have not yet identified specific immune responses that correlate with protection against intracellular pathogens. Finding these would help in predicting whether a new vaccine will work for these kinds of microbes.

The author of more than 80 research articles appearing in peer-reviewed scientific journals, Karen earned her B.A. degree in Chemistry from Wake Forest University, and her Ph.D. in Microbiology and Immunology at Duke University. She undertook postdoctoral training at the Uniformed Services University of the Health Sciences (USUHS) and National Institutes of Health (NIH). She then established an independent research laboratory at the Walter Reed Army Institute of Research before coming to FDA.

In addition to her own research, Karen reviews new research as a member of several journal editorial boards, including the Journal of Immunology (AAI) and Infection and Immunity (ASM). She also serves on numerous NIH grant review panels. She also has long-standing interests in science management and ethics. In that vein, Karen writes a long-running column on lab management for the Association of Women in Science (AWIS), and is further developing her interests in science communication by pursuing graduate studies in science and medical writing at Johns Hopkins University.

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