Staphylococcus Aureus Toxoids Phase 1-2 Vaccine Trial
Condition: Staphylococcus Aureus
MeSH terms: Staphylococcal Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study involves the use of investigational vaccines. A vaccine is a medicine that causes
      the body to make antibodies. Antibodies help destroy foreign substances that enter the body.
      The purpose of this study is to find the right dose of a new vaccine that is safe and
      produces a good immune response (how well your body recognizes and defends itself against
      harmful foreign substances). There are two Staphylococcus aureus toxoids (components or
      antigens) under investigation in this study; one of them is a protein known as rAT and the
      other is a protein known as rLukS-PV. They are being developed to see if they are effective
      at preventing infections caused by the bacteria Staphylococcus aureus.
    

Detailed description: 
      Staphylococcus aureus is a leading cause of skin and soft tissue infections. Antibiotic
      resistance, such as seen with new community-acquired methicillin-resistant strains, presents
      a major challenge in treating and preventing these infections. Therefore, a preventative
      vaccine is considered a potentially better approach.

      This study assesses the safety and immunogenicity of monovalent and bivalent S. aureus
      vaccine components. Healthy adult subjects will be randomized to receive 1 dose of monovalent
      or bivalent toxoid vaccine, or placebo in a dose escalation schedule.

      Antigen-specific antibody will be measured by ELISA in sera collected for three months after
      injection. Safety data will be collected as 7 day reactogenicity diaries after each
      injection, adverse events and Staphylococcus aureus and skin and soft tissue infections will
      be collected through Day 84, and serious adverse events and chronic illnesses will be
      collected for the full 6 month study period.

      To evaluate the possible utility of booster doses, the cohort receiving the highest dose of
      bivalent antigen will have a 2nd dose administered at Day 84, with a new 7-day reactogenicity
      diary and sera collected after the 2nd dose. All subjects will be followed up with a 6 month
      phone call after vaccination or booster.

      The total subject observation period will be for 24 weeks from Day 0, plus 12 additional
      weeks for the cohorts that receive a 2nd dose. With a recruitment period of 4 months, the
      study duration is expected to be approximately 13 months.
    

Intervention name(s): Monovalent rAT; Monovalent rLukS-PV; Bivalent rLukS-PV / rAT; Placebo with adjuvant; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 10, 25, 50 or 100 μg; 10, 25, 50 or 100 μg; 10, 25 or 50 μg; Placebo with adjuvant; Placebo saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Staphylococcus aureus; Skin and soft tissue infection; Methicillin-resistant Staphylococcus aureus; Recombinant alpha-toxoid (rAT); Recombinant LukS subunit of Panton-Valentine Leukocidin (rLukS-PV)