News Release

Innovative smallpox vaccine research study to be conducted at Case Medical Center

University hospitals and Case Western Reserve University School of Medicine to lead national study

Peer-Reviewed Publication

Case Western Reserve University

CLEVELAND -- University Hospitals Case Medical Center (UHCMC) and Case Western Reserve University School of Medicine are part of a nationwide research study to determine the safety and effectiveness of a new smallpox vaccine geared toward adults ages 18 to 34 who have never been vaccinated against the disease. The study is the first of its type in Northeast Ohio.

The current FDA-approved vaccine, Dryvax®, is not recommended for use on everyone because of the potential for serious side effects in certain individuals. “For example, the current vaccine cannot be used in immune-compromised individuals, such as patients with HIV or individuals with certain skin conditions such as eczema,” says Robert A. Salata, M.D., chief of the Division of Infectious Diseases at Case Western Reserve University School of Medicine and UHCMC.

The new vaccine, IMVAMUNE®, is different from Dryvax® in that it contains a more weakened form of the live-virus within the vaccine.

“Because the vaccine is weakened, the side effects should be minimized enough to give the vaccine to all individuals, even those whose immune systems are suppressed,” says Dr. Salata. “Our hope is that the new vaccine will be a safer alternative to the current vaccine.”

UHCMC and the School of Medicine will act as a subunit of St. Louis University’s Center for Vaccine Development, which is one of seven national testing sites known as Vaccine and Treatment Evaluation Units (VTEUs), designated by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The research study, which is actively recruiting and begins here June 15, will follow 215 volunteers nationwide over a two-year period. Volunteers must be in general good health and must not have previously been vaccinated against smallpox.

Smallpox is a contagious and sometimes fatal infectious disease characterized by raised bumps that appear on the face and body of an infected person. There is no specific treatment for smallpox disease, and the only prevention is vaccination. The World Health Organization declared the disease eradicated in 1980 with the success of a worldwide vaccination program. Routine vaccination against smallpox among the general public was ceased in 1972 because it was no longer necessary for prevention. However, recent threats of bioterrorism after 9/11 have spurred the development of a new safer vaccine that can be given to immune-compromised individuals.

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For more information about the study and how to participate, call the Division of Infectious Diseases at 216-368-2003, or e-mail vaccinecenter@case.edu . Additional information can be found under the vaccine research unit link at http://www.cwru.id.org.

About University Hospitals Case Medical Center:

With 150 locations throughout Northeast Ohio, University Hospitals serves the needs of patients through an integrated network of hospitals, outpatient centers and primary care physicians. At the core of our Health System is University Hospitals Case Medical Center. The primary affiliate of Case Western Reserve University School of Medicine, University Hospitals Case Medical Center is home to some of the most prestigious clinical and research centers of excellence in the nation and the world, including cancer, pediatrics, women's health, orthopedics and spine, radiology and radiation oncology, neurosurgery and neuroscience, cardiology and cardiovascular surgery, organ transplantation and human genetics. Its main campus includes the internationally celebrated Rainbow Babies & Children's Hospital, ranked best in the Midwest and first in the nation for the care of critically ill newborns; MacDonald Women's Hospital, Ohio's only hospital for women; and Ireland Cancer Center, which holds the nation's highest designation by the National Cancer Institute of Comprehensive Cancer Center. For more information, go to http://www.uhhospitals.org

About Case Western Reserve University School of Medicine:

Founded in 1843, Case Western Reserve University School of Medicine is the largest medical research institution in Ohio and 12th largest among the nation’s medical schools for research funding from the National Institutes of Health. Eleven Nobel Laureates have been affiliated with the school. The School of Medicine is recognized throughout the international medical community for outstanding achievements in teaching and in 2002, became the third medical school in history to receive a pre-eminent review from the national body responsible for accrediting the nation’s academic medical institutions. The School’s innovative and pioneering Western Reserve2 curriculum interweaves four themes--research and scholarship, clinical mastery, leadership, and civic professionalism--to prepare students for the practice of evidence-based medicine in the rapidly changing health care environment of the 21st century. Annually, the School of Medicine trains more than 600 M.D. and M.D./Ph.D. students and ranks in the top 25 among U.S. research-oriented medical schools as designated by U.S. News and World Report Guide to Graduate Education. The School of Medicine’s primary clinical affiliate is University Hospitals Case Medical Center and is additionally affiliated with MetroHealth Medical Center, the Louis Stokes Cleveland Department of Veterans Affairs Medical Center, and the Cleveland Clinic Foundation, with which it established the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in 2002. http://casemed.case.edu


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