Natural History of Anthrax: a Study of Primary Infected, Recovered, and Exposed Individuals (SPoRE); and Evaluation of AVA-Vaccinated Recipients

Study Summary

This study will examine pathophysiology and immune response of anthrax in infected or exposed individuals to learn more about the disease symptoms, prevention and response to treatment. In addition, it will evaluate immune response to the anthrax vaccine AVA (Anthrax Vaccine Adsorbed) in healthy, non-infected individuals. The following individuals may be eligible for this study: 1. People with confirmed or suspected anthrax (inhalational, cutaneous or gastrointestinal, either acute or recovering); 2. People exposed to anthrax who have no clinical symptoms. 3. Healthy people who have not been exposed to anthrax and have been vaccinated with AVA. Those enrolled in the study will undergo the following tests and procedures. Infected and exposed individuals: * Symptomatic participants will have the following clinical procedures if medically necessary: * a) blood tests for cell counts, chemistries and evidence of anthrax bacteria; * b) nasal swab to test for evidence of anthrax * c) chest X-ray; * d) computed tomography (CT) scan (special X-rays to examine the lungs or abdomen); * e) echocardiogram to examine the heart * f) magnetic resonance imaging (MRI), a special imaging test using a magnetic field and radio waves to examine the infected area of skin and soft tissue for patients with cutaneous anthrax. * All subjects (with or without symptoms) will have the following research procedures: * a) blood tests to examine immune response to anthrax; * b) throat swab to test for evidence of anthrax * c) nasopharyngeal wash to test for anthrax. Water is sprayed into the nostrils and then allowed to drain for collection in a cup; * d) induced sputum to test for presence of and immune response to anthrax. A mask with a saline mist is placed over the subject s mouth and nose, causing the subject to cough and produce sputum from the lungs. The sputum is collected in a cup this is for individuals 18 and older who do not undergo bronchoscopy, described below. * Participants 18

Primary Outcome

This study is intended to evaluate the natural history of anthrax and the immune response to anthrax over time in four subpopulations of men, women and children with: --acute infection (confirmed or suspected) --recovering phase of infection --exposure to infection --no known or no exposure to infection but a history of anthrax vaccination (AVA) (since no children have received AVA, they will be excluded from this subgroup)

Conditions Studied

Study Locations (1)