University Hospitals To Conduct Innovative Smallpox Vaccine Research Study
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.