Tolerability and Immunogenicity of rBV A/B for the Production of BabyBIG®
Condition: Botulism
MeSH terms: Botulism
Intervention: rBV A/B
Intervention description: Recombinant Botulinum Vaccine A/B, rBV A/B
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This Phase 2, open-label, uncontrolled study designed to evaluate safety, tolerability, and
      immunogenicity of a single dose of rBV A/B in healthy participants previously immunized with
      pentavalent botulinum toxoid (or pentavalent botulinum toxoid and rBV A/B) for occupational
      protection will be conducted to collect source plasma for potential use in the production of
      BabyBIG and to evaluate safety and immunogenicity of the vaccine in these participants over a
      12-week period, with a follow-up safety assessment at 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have received pentavalent botulinum toxoid (or pentavalent botulinum toxoid and rBV
             A/B) for occupational protection under BB IND 0161 (or BB-IND-0161 and IND 015155)

          2. Be 18 to 69 years old at the time of consent

          3. Be healthy and have an acceptable medical history that will not interfere with the
             objectives of the study

          4. Meet the participant suitability requirements and recommendations for source plasma
             donors outlined in Appendix A.

          5. If female, and of childbearing potential, have a negative pregnancy test at screening
             and within 24 hours prior to vaccination and must not plan to become pregnant until
             after the last plasma donation or until the Week 12 visit ([whichever occurs last].

          6. Have the ability to understand the requirements of the study, have provided written
             informed consent as evidenced by signature on an informed consent form (ICF) approved
             by the Committee for the Protection of Human Subjects, and have agreed to abide by the
             study restrictions and to return for the required assessments

          7. Agree to complete the participant home diary on a daily basis for 7 days post
             vaccination, as well as to report any adverse events and concomitant medications
             during the study period

          8. Have provided written authorization for use and disclosure of protected health
             information

          9. Agree not to donate blood or blood products (outside of study procedures) until after
             the last plasma donation or until the Week 12 visit (whichever occurs last)

         10. Have personal health insurance

        Exclusion Criteria:

          1. Be pregnant or nursing

          2. Have a history of laboratory evidence of syphilis, acquired immunodeficiency syndrome,
             Creutzfeldt-Jakob disease, or infection with human immunodeficiency viruses (HIV) 1 or
             2, human T-cell lymphotropic virus 1, hepatitis B virus (HBV), or hepatitis C virus
             (HCV)

          3. Have had a prior severe (Grade 3 or higher) local or severe (Grade 3 or higher)
             systemic reaction to last immunization with pentavalent botulinum toxoid or a prior
             severe immediate hypersensitivity reaction or severe systemic reaction to last
             vaccination on Day 0 with rBV A/B

          4. Have known allergy to aluminum, yeast, or other components of the vaccine

          5. Have donated one or more units of blood or undergone plasmapheresis within 49 days of
             the Vaccination Visit (Day 0)

          6. Have received blood product or immunoglobulin within 6 months prior to study entry or
             plans to receive such products during the study period (exclusive of returned red
             blood cells as part of the plasmapheresis procedure). For participants who choose to
             donate plasma, this will apply until their last plasma donation or at the Week 12
             visit (whichever occurs last)

          7. Have received licensed nonliving vaccine within 14 days prior to study entry, or
             licensed live vaccine within 60 days prior to study entry

          8. Have 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 period. For participants who choose to donate plasma, this will
             apply until their last plasma donation or at the Week 12 visit (whichever occurs last)

          9. Have received prescription immunosuppressive or immunomodulatory agents, including
             parenteral, inhaled, or oral corticosteroids within 3 months of study entry or plans
             on receiving such therapy at any time during the study period [For participants who
             choose to donate plasma, this will apply until their last plasma donation or at the
             Week 12 visit (whichever occurs last)], with the exceptions mentioned below

               -  Participants 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

         10. Have received cytotoxic therapy at any time in the previous 5 years before study entry

         11. Have an active systemic or recurrent disease that would place the participant at
             unacceptable risk of injury, require hospitalization, or require surgical intervention
             (This includes active mental illness or history of mental illness not responsive to
             treatment.)

         12. Have a history of alcohol or drug abuse or dependence within 12 months of study entry

         13. Have past, present, or suspected illicit injection drug use

         14. Have inflammatory, vasculitic, or rheumatic disease, including systemic lupus
             erythematosus, polymyalgia rheumatica, rheumatoid arthritis, or scleroderma (Stable
             osteoarthritis treated with physical therapy and nonsteroidal anti inflammatory drugs
             is not an exclusion criterion.)

         15. Have any acute or chronic neuromuscular or neurologic disorder

         16. Have clinically confirmed hepatic or renal insufficiency

         17. Have uncontrolled hypertension, as defined a systolic blood pressure greater than 160
             mmHg and diastolic blood pressure greater than 90 mmHg

         18. Have moderate to severe asthma, chronic obstructive pulmonary disease, or other
             significant pulmonary disease

         19. Have a seizure disorder

         20. Have moderate or severe illness or oral temperature of 100.4°F or greater within 3
             days of Vaccination Visit (Day 0)

         21. Be unsuitable for participation in this study for any reason, as assessed by the
             investigator