Natural History of Anthrax: A Study of Primary Infected, Recovered, and Exposed Individuals and Evaluation of AVA Vaccinated Recipients

What this Trial Is About

Researchers are studying anthrax to better understand how the disease affects infected or exposed individuals. The study focuses on symptoms, prevention, and how the immune system responds to anthrax. It also evaluates the immune response to the anthrax vaccine AVA in healthy people who have not been infected. The study tracks participants over time, including those with confirmed or suspected anthrax infections, those exposed but without symptoms, and healthy vaccinated volunteers. Participants include people with different forms of anthrax infection (inhalational, cutaneous, gastrointestinal), individuals exposed to anthrax without symptoms, and healthy vaccinated individuals. Infected and exposed participants may undergo various clinical tests such as blood tests, nasal swabs, chest X-rays, CT scans, echocardiograms, MRIs, and optional procedures like lymph node biopsies and bronchoalveolar lavage. Healthy vaccinated volunteers have blood drawn and may undergo leukapheresis or plasmapheresis to collect white blood cells and plasma. Throughout the study, infected and exposed participants receive medical history and physical exams, and are offered antibiotic treatment or prevention according to CDC guidelines. They are monitored for at least 24 months after treatment. All participants have blood tests and respiratory samples collected to study immune responses. The main outcome measured is the natural course of anthrax and immune responses over two years. The study is observational and includes ongoing safety and health monitoring.

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