Safety, Tolerability, and Immunogenicity Study of Investigational Recombinant Botulinum Vaccine A/B (rBV A/B) in Volunteers Previously Immunized With Investigational Pentavalent Botulinum Toxoid
Condition: Botulism
MeSH terms: Botulism
Intervention: rBV A/B
Intervention description: rBV A/B injections will consist of a single 40 µg injection of total antigen (20 µg of Antigen A and 20 µg of Antigen B) adsorbed to 0.2% (wt/vol) Alhydrogel™, in a total dose volume of 0.5 mL. The vaccine will be administered by intramuscular injection in the deltoid muscle, preferably in the nondominant arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Botulism Vaccine

Summary:

      Study rBV A/B-CL-001 is a Phase 2b, 2-part, open-label, uncontrolled study to evaluate
      safety, tolerability, and immunogenicity of a single dose of recombinant botulinum vaccine
      A/B (rBV A/B) for the production of BabyBIG in volunteers previously immunized with the
      pentavalent botulinum (PBT) toxoid. This study is designed to determine neutralizing antibody
      levels for botulinum toxin types A and B in healthy subjects who were previously immunized
      with the PBT for occupational protection and who receive the rBV A/B. Subjects with titers of
      the neutralizing antibodies against the toxins would be candidates for plasma donation for
      BabyBIG production.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The volunteer has received pentavalent botulinum toxoid for occupational protection
             under BB IND 0161, with the previous pentavalent botulinum toxoid dose at least 6
             months prior to the planned rBV A/B dose.

          -  The volunteer is between the ages of 18 and 69 years at the time of consent.

          -  The volunteer is healthy and has an acceptable medical history.

          -  The volunteer meets the subject suitability requirements and recommendations for
             source plasma donors (for Part 2 subjects only).

          -  The volunteer, if female and of childbearing potential, is not pregnant or lactating,
             and agrees to use an acceptable form of FDA-approved contraception for the duration of
             the study.

          -  The volunteer has the ability to understand the requirements of the study and provide
             informed consent.

          -  The volunteer agrees to complete the subject diary on a daily basis for 7 days
             post-vaccination and to report concomitant medication and adverse events during the
             study period.

          -  The volunteer provides written authorization for use and disclosure of protected
             health information.

          -  The volunteer agrees not to donate blood or blood products (outside of study
             procedures) during the course of the study.

          -  The volunteer has personal health insurance.

        Exclusion Criteria:

          -  Be pregnant or nursing

          -  The volunteer has a history of laboratory evidence of syphilis, acquired
             immunodeficiency syndrome, Creutzfeldt-Jakob disease, or infection with human
             immunodeficiency viruses 1 or 2, human T cell lymphotropic virus 1, hepatitis B virus,
             or hepatitis C virus.

          -  The volunteer had prior severe local or severe systemic reaction to last immunization
             with pentavalent botulinum toxoid.

          -  The volunteer has a known allergy to aluminum compounds, yeast, or other components of
             the vaccine.

          -  The volunteer has donated one or more units of blood or undergone plasmapheresis
             within 28 days before screening.

          -  The volunteer has received a blood product or immunoglobulin within 6 months of
             screening or plans to receive such products during the study.

          -  The volunteer has received licensed nonliving vaccine within 14 days before study
             entry or licensed live vaccine within 60 days before study entry.

          -  The volunteer has received investigational products (drugs, biologics, vaccines, or
             implantable devices) 60 days prior to study entry or plans to receive experimental
             products at any time during the study.

          -  The volunteer has received prescription immunosuppressive or immunomodulatory agents,
             including parenteral, inhaled, or oral corticosteroids within 3 months before
             screening or plans on receiving such therapy at any time during the study with the
             exceptions (Subjects who have used prescription topical steroids may be enrolled 2
             weeks after the therapy is completed; Intra-articular, bursal, or tendon injectable
             steroids are permitted; Any over-the-counter topical steroid use is permitted;
             Ophthalmic and intranasal steroids are permitted).

          -  The volunteer has received cytotoxic therapy at any time in the previous 5 years to
             study entry.

          -  The volunteer has an active systemic or recurrent disease that would place the subject
             at unacceptable risk of injury, require hospitalization, or require surgical
             intervention.

          -  The volunteer has a history of alcohol or drug abuse within 12 months before
             screening.

          -  The volunteer has past, present, or suspected illicit injection drug use.

          -  The volunteer has inflammatory, vasculitic, or rheumatic disease, including systemic
             lupus erythematosus, polymyalgia rheumatica, rheumatoid arthritis, or scleroderma.

          -  The volunteer has clinically recognized hepatic or renal insufficiency.

          -  The volunteer has uncontrolled hypertension.

          -  The volunteer has moderate to severe asthma, chronic obstructive pulmonary disease, or
             other significant pulmonary disease.

          -  The volunteer has a seizure disorder.

          -  The volunteer has moderate or severe illness or oral temperature of 100.4°F or greater
             within 3 days prior to immunization.

          -  The volunteer is determined by the investigator to be unsuitable for participation in
             this trial for any reason.