Phase I STEBVax in Healthy Adults
Condition: Toxic Shock Syndrome Staphylococcal
MeSH terms: Shock, Septic; Shock
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to test the safety of a new vaccine, STEBVax, which may
      lead to a useful treatment for toxic shock syndrome. The second purpose is to determine
      whether STEBVax causes the body to produce antibodies (proteins that fight infection) to help
      the body resist disease. Researchers expect STEBVax shots will cause the development of
      antibodies in the blood. Study participants will include up to 42 healthy adults, ages 18-40,
      from the University of Maryland Baltimore community. Participants will be assigned to one of
      7 vaccine dose groups. Assignment to dosage groups will depend on when individuals are
      enrolled in the study. Study procedures will include blood sampling, urine collection, and
      physical examinations. Subjects will maintain a memory aid documenting daily oral
      temperatures and possible vaccine side effects. Participants will be involved in study
      related procedures for up to 201 days.
    

Detailed description: 
      This study is a Phase I study of the safety and immunogenicity of recombinant Staphylococcal
      Enterotoxin B vaccine (STEBVax) in healthy adults. STEBVax is a recombinant mutated form of
      staphylococcal enterotoxin B (SEB) containing three point mutations that disrupt the
      interaction of the toxin with human major histocompatibility complex (MHC) class II receptors
      and render the protein non-toxic while retaining most of the immunogenicity. The primary
      intended result of this program is the development of a hyperimmune serum for treatment of
      toxic shock syndrome (TSS) originating from nosocomial, environmental or potential
      bioterrorist events. An additional long-term goal is the development of a multivalent vaccine
      and immunotherapeutic for treating or preventing diseases caused by Staphylococcus (S.)
      aureus. The long-range goal is to develop a vaccine that will protect against a broad range
      of staphylococcal superantigens. The primary objective is to evaluate and assess the safety
      of parenterally administered STEBVax vaccine in healthy adult subjects over a range of doses
      from 0.01 to 20 mcg by intramuscular injection. The secondary objectives are to determine the
      immunogenicity of STEBVax vaccine over a range of doses as determined by the rate and titer
      of seroconversion with serum anti-S. aureus enterotoxin B IgG antibodies measured by
      enzyme-linked-immunosorbent serologic assay (ELISA). Participants will include 28 healthy
      adult subjects from the University of Maryland Baltimore community. Subjects will receive a
      dose of STEBVax in Alhydrogel adjuvant at one of the following doses: 0.01, 0.1, 0.5, 2.5, 10
      or 20 mcg or 2 doses of 20 mcg given 21 days apart. STEBVax will be administered as a single
      0.5 mL intramuscular injection. Subjects will be followed for safety, reactogenicity, and
      immune response after vaccination. Subjects will be observed in the clinic for at least 8
      hours after vaccination and remain in the Baltimore-Washington metropolitan area for 7 days
      after vaccination.
    

Intervention name(s): Aluminum hydroxide; STEBVax vaccine
Intervention type(s): Drug; Biological
Intervention description(s): Single dose of recombinant staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 0.01, 0.1, 0.5, 2.5, 10 or 20 mcg intramuscular and 2 doses of 20 mcg intramuscular 21 days apart. STEBVax vaccine will be administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the non-dominant arm; subjects in the 2 dose cohort will have the vaccine administered in the alternate arm.; Single dose of recombinant staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 0.01, 0.1, 0.5, 2.5, 10 or 20 mcg intramuscular and 2 doses of 20 mcg intramuscular 21 days apart. STEBVax vaccine will be administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the non-dominant arm; subjects in the 2 dose cohort will have the vaccine administered in the alternate arm.
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Staphylococcal enterotoxin B, vaccine, Staphylococcus aureus, toxic shock syndrome