Protocol Number: 03-I-0151
- how to diagnose and treat complications of vaccinia virus; - how the virus causes these complications; and, - how the body fights the virus and whether the attempt to fight the virus contributes to the complications. - Anyone who has received smallpox inoculation (except children who weigh less than 10 kilograms, or 22 pounds) or was exposed to someone who was recently vaccinated, and has an illness that is likely due to the vaccination may be eligible for this study. The illness has to have started within 30 days of vaccination or exposure. Complications of smallpox vaccination include: - inadvertent inoculation - spread of the vaccine virus from the vaccination site by direct contact to a distant site or to another person, with the development of skin or eye lesions; - generalized vaccinia - spread of the vaccine virus from the vaccination site by the bloodstream few or multiple distant sites; - erythema multiforme - development of a specific rash (often with a bulls-eye appearance) - eczema vaccinatum - development of extensive skin lesions in people who may have had eczema in the past or who currently have eczema; - progressive vaccinia - progressively enlarging ulcers at the site of the initial vaccination or at distant sites; and, - postvaccinal encephalitis - development of an altered level of alertness, or new onset of weakness in one or more parts of the body. - Other complications from smallpox vaccination, including myocarditis, may also be considered for this study. Participants will undergo some or all of the following tests and procedures: - history of the current illness and physical examination; - blood tests to study the immune system and look for signs of infection with vaccinia virus or other organisms; - study of DNA (hereditary material) to see if differences in certain genes are associated with differences in immune responses to the vaccine; - photographs of skin lesions or other physical findings ; - skin and throat swabs; - skin biopsy (surgical removal of a small tissue sample) to look for vaccinia virus or other causes of the illness; and, - x-rays, computerized tomography (CT) scans, magnetic resonance imaging (MRI) scans, and lumbar punctures (spinal taps) Some patients may receive treatment for their illness. Medications include vaccinia immune globulin (pooled antibodies to the virus) or cidofovir (a medicine that inhibits the virus). NIH will provide treatment of the acute illness, but patients will be referred back to their regular doctor for any chronic health problems that result from smallpox vaccination.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/20/2008
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