Safety, Tolerability, and Immunogenicity Study of Investigational Recombinant Botulinum Vaccine A/B (rBV A/B) in Volunteers Previously Immunized With Investigational Pentavalent Botulinum Toxoid

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.