CDC Anthrax Vaccine Clinical Trial
HealthyAnthrax Clinical Trial Objectives: To assess whether: Anthrax vaccine (AVA or BioThrax, BioPort Corp. Lansing MI) administered by the intramuscular (IM) route elicits antibody responses that are not inferior (i.e., "non-inferior") to that achieved by the currently licensed schedule. BioThrax administered by the IM route and containing fewer numbers of doses elicits antibody responses that are not inferior (i.e., "non-inferior") to that achieved by the currently licensed schedule. Differences in reactogenicity exist between the IM and subcutaneous (SQ) administration of BioThrax. Additionally for the final report we will assess whether: Occurrence of adverse events following AVA administration is influenced by selected risk factors.
Intramuscular Dose-Escalation Study With ETI-204 in Adult Volunteers
Inhalational AnthraxThis study is to evaluate the safety, local tolerability, pharmacokinetics (PK) and immunogenicity of escalating single intramuscular (IM) doses of ETI-204 in healthy volunteers
Safety, Tolerability and PK of Intravenous (IV) ETI-204 Alone and in Presence of Ciprofloxacin in...
Inhalational AnthraxEvaluate the safety, tolerability and pharmacokinetics (PK) of intravenous (IV) ETI-204 alone and in the presence of IV and oral ciprofloxacin
Safety, Tolerability, and PK of a Single Intravenous Dose of ETI-204 in Adult Volunteers
Inhalational AnthraxTo evaluate the safety and tolerability and pharmacokinetics (PK) of a single intravenous (IV) dose of ETI-204 in adult volunteers.
VHA Clinicians and Bioterror Events: Interactive Web-based Learning
SmallpoxAnthraxOur 4-year project uses public domain software and content developed by a University of Alabama at Birmingham (UAB) team and updates, refines, and tailors it to the unique clinician populations and electronic educational applications of VAMCs We are testing an innovative, web-based intervention adapted specifically for the VA to increase syndromic recognition, treatment, and post-exposure prophylaxis of biological warfare agents at multiple VA sites via a randomized controlled trial (RCT). Ultimately, we will disseminate the intervention throughout the entire VA system.
Safety, Tolerability and PK of Repeat Administration of Intravenous ETI-204 in Adult Volunteers...
Inhalational AnthraxTo evaluate the safety, tolerability, pharmacokinetics and immunogenicity of repeat administration (two doses) of intravenous (IV) ETI-204.
Plasmapheresis of Anthrax-Vaccinated Subjects for Production of Anthrax Immune Globulin
AnthraxThis protocol is a joint project of the National Institutes of Health, the Centers for Disease Control and the United States Army Medical Research Institute for Infectious Diseases. It is designed to collect plasma from healthy employees of the Department of Defense who have been vaccinated against anthrax. The collected plasma will be pooled to make an anthrax-fighting antibody solution called anthrax immune globulin intravenous (AIGIV). This solution will be used for: Animal experiments to test its effectiveness in preventing the development of anthrax after inhalation exposure; Treating people severely ill with anthrax who are not improving with standard antibiotic therapy; and Treating people exposed to spores of the bacteria that cause anthrax to try to prevent development of the disease. Healthy volunteers between 18 and 65 years of age who have received at least four doses of the anthrax vaccine and who meet the criteria for blood donors may be eligible to participate in this study. Volunteers will be recruited from Department of Defense civilian and military employees. Candidates will be screened with an interview and blood tests. Participants will undergo the following procedures: Have a health history screen for donating plasma Measurement of heart rate, blood pressure and temperature Fingerstick to check hemoglobin level Blood tests for HIV, hepatitis B and C, syphilis and other infectious diseases Blood test for anthrax antibody levels Plasmapheresis to collect blood plasma (the liquid part of the blood) In plasmapheresis, whole blood is drawn through a needle placed in an arm vein. The blood flows into a cell separator machine, where it is spun to separate the plasma from the blood cells. The plasma is collected in a plastic bag in the machine, while the rest of the blood is returned to the donor through the needle in the arm. During the procedure, the donor is given a blood thinner called citrate to prevent the blood from clotting while it is in the cell separator machine. The procedure lasts from 60 to 90 minutes. Only a small fraction of the body's total plasma is removed, and it is quickly replaced by the body with no long-term health effects. Participants may be requested to donate plasma as often as every 3 to 4 days or as infrequently as once a month for a maximum of six donations.
Special Drug Use Investigation of Ciproxan Injection in Pediatrics
Cystitis / Pyelonephritis / Cystic Fibrosis / AnthraxThe objective in this study is collecting post-marketing information on the safety and efficacy of Ciproxan injection under the routine clinical practice.
Febrile Whole Blood Specimen Collection and Testing
Febrile InfectionAnthraxWhole blood samples will be collected from febrile patients presenting with fever of unknown origin and flu-like syndromes. Collection sites will consent patients and collect one (1) 4 mL whole blood sample from adults and either (1) 2 mL pediatric whole blood sample or 0.5 mL whole blood sample collected in a micro collection container from pediatric patients from each patient enrolled into the study. Study site will test whole blood samples received from collection sites daily using the Applied Biosystems™ Bacillus anthracis Detection Kit. Data generated will demonstrate product specificity when testing febrile whole blood samples.
Evaluation of the Clinical Specificity of the Active Anthrax Detect™ Plus (AAD Plus) Lateral Flow...
AnthraxThe primary objective of the study is to determine the estimated clinical specificity of the AAD Plus. A secondary objective is to determine the estimated sensitivity of the AAD Plus as 10% of the study subject samples will be contrived to be positive.