Study of Reactogenicity, Safety, Immunogenicity, and Pock Lesion Formation of a Cell-Cultured Smallpox...
SmallpoxThis study will evaluate the safety and efficacy of both Dryvax® and the new cell-cultured vaccine (CCSV) in a comparative fashion. Across 3 cohorts, 150 vaccinia-naive volunteers will be randomly assigned to receive either CCSV (100 volunteers) or Dryvax® (50 volunteers) in a blinded fashion. Subjects will be followed closely for up to 6 months and a subgroup of volunteers will be followed up to 3 years in order to evaluate the duration of immunity following vaccination. Another cohort will enroll 100 vaccinia-experienced volunteers and randomly assign them to receive either CCSV (50 volunteers) or Dryvax® (50 volunteers) and a sub group will be followed up to 3 years. A fifth cohort will enroll 100 vaccinia-naive volunteers and randomly assign them to receive different dilutions of CCSV (1:1, 1:5, 1:25, and 1:50).
Vaccinia Virus Vaccine (APSV) in Vaccinia- Naive Subjects: PILOT
SmallpoxTo define the safety of vaccination with APSV as determined by the reactogenicity of the vaccine and the development of expected and un-expected adverse events associated with vaccination. To assess the proportion of individuals who respond to vaccination with a "take" (those who form a visible lesion at the injection site) 6 to 8 days after the vaccination.
Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in Patients With Atopic...
DermatitisAtopic1 moreThe purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in populations with atopic disorders.
Study on Safety, Tolerability and Immunogenicity of an MVA Vaccine Administered to Healthy Subjects...
SmallpoxThe purpose of this study is to collect information on the safety, tolerability and immunogenicity of an investigational smallpox vaccine at different doses and using different routes of administration in vaccinia-naive and vaccinated healthy volunteers
Human Immune Responses Smallpox
SmallpoxThe purpose of this study is to attempt to identify the immune response of healthy adults to an investigational dilution of the Dryvax smallpox vaccine. In addition, we will try to determine whether certain genetic characteristics influence the size of the sore around the vaccination site, and use blood samples from subjects in the study to make a new form of antibody that could be given to people with vaccine side effects.
Dressing Preparations for Smallpox
SmallpoxThe primary purpose of this study is to find out the risk of spreading the vaccine virus, vaccinia, from the smallpox vaccination site when different types of bandages are used to cover the site. The study will also look at how each bandage type affects the healing of the sore. Study participants will include healthy individuals, 18-50 years old, who have not previously received a smallpox vaccine and healthy individuals, 18-50 years old, who have received a previous smallpox vaccine. All participants will receive the smallpox vaccine and be randomly assigned to 1 of 3 different bandage groups to cover the vaccine site: standard gauze dressing attached with paper tape, Opsite gauze-impregnanted occlusive dressing (attached by paper tape and waterproof), and Allevyn hydropolymer dressing (which is self-adhesive and highly absorbent). Volunteers will be involved in study related procedures for up to 252 days.
VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV
Smallpox Vaccine Adverse ReactionObjectives: To vaccinate plasma donors with the ACAM2000 smallpox vaccine thereby inducing an immune response resulting in high anti-vaccinia antibody titers. The collection of donor plasma will be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV). To ensure the safety of plasma donors vaccinated with ACAM2000 through the implementation of risk factor screening procedures and the collection of post-vaccination safety data.
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 TPOXX in Adults Weighing More Than 120 KG
SmallpoxSafety and PK study in adults weighing more than 120 kg
Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders
SmallpoxAn open-label, drug-drug interaction study with TPOXX and phosphate binders.