Safety, Tolerability and Immunogenicity of Recombinant Anthrax Vaccine Compared With Anthrax Vaccine Adsorbed
Condition: Bacillus Anthracis (Anthrax)
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a dose ranging study comparing different vaccine schedules of rPA vaccine, for
      Anthrax, to the licensed dose of AVA, another Anthrax vaccine. Safety and the capability to
      induce an immune response will be evaluated.
    

Detailed description: 
      Anthrax is a zoonotic disease, occurring in wild and domestic mammals, caused by the
      spore-forming bacterium Bacillus anthracis (B. anthracis). Anthrax occurs in humans when they
      are exposed to infected animals, tissue from infected animals or when they are directly
      exposed to B. anthracis or its spores. Depending on the route of infection, anthrax disease
      can occur in three forms: cutaneous, gastrointestinal, and inhalation. In the United States
      of America (USA), the annual incidence of human anthrax has declined from approximately 130
      cases annually in the early 1900s to no cases during 1999 to 2000. However, in the USA,
      shortly after September 11th, 2001, there were 22 cases (18 confirmed) of inhaled and
      cutaneous anthrax infection that were related to contaminated mail. The development of a new
      anthrax vaccine is necessary because the current AVA vaccine requires the growth of B.
      anthracis in its manufacturing process and has a complex administration regimen of six
      administrators of vaccine in 18 months. As protective antigen (PA) is a central virulence
      factor in anthrax pathogenesis and a major immunogen in the current vaccine, a recombinant,
      acellular, protective antigen-based anthrax vaccine, could offer an improved manufacturing
      process and a simpler dosing schedule. Furthermore, the vaccine could offer improved
      protection against inhaled B. anthracis, and could, when used in conjunction with
      antibiotics, form part of the management of anthrax exposed individuals. This is a dose
      ranging study comparing different primary vaccine schedules of rPA Anthrax vaccine to the
      licensed dose of Anthrax Vaccine Adsorbed. The study is designed to measure the immune
      response, and to evaluate the safety and tolerability of different doses of rPA Anthrax
      Vaccine. After subjects have given informed consent, they will undergo physical exams,
      medical history screening, pregnancy tests, ECG, HIV, Hepatitis B & C tests, safety blood
      tests, and urine drug and alcohol screen. Subjects will be asked to complete a diary card to
      record any symptoms they may experience. The subjects that receive AVA will be offered the
      opportunity to complete the licensed course of vaccination which would involve AVA
      vaccinations at 6, 12 and 18 months.
    

Intervention name(s): AVA; rPA vaccine containing alhydrogel
Intervention type(s): Biological; Biological
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Anthrax