Tolerability and Immunogenicity of a Single 40-ug Dose of rBV A/B for the Production of BabyBIG®

NCT06112834 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: rBV A/B-CL-003
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Botulism

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects Achieving Equal to or Greater Than 4-Fold Increase in Neutralizing Antibody Concentration (NAC)

  The primary immunogenicity endpoint is the proportion of participants achieving a four times or greater increase in NAC by Week 4 compared with Week 0. A positive response will be defined as achieving this level of increase in at least 50% of the participants for botulinum toxin type A and type B.

  Week 0 to Week 4

Secondary Outcomes (2)

• Proportion of Subjects Achieving 2-Fold Increase in Area Under the Plasma Concentration-Time Curve in Neutralizing Antibody Concentration (NAC)

  Week 0 to Week 12

• Proportion of Subjects Achieving Equal to or Greater Than 3-Fold Increase in Neutralizing Antibody Concentration (NAC)

  Week 0 to Week 4

Other Outcomes (1)

• Volume of Plasma Collected with Anti-Botulinum Toxin Type A and Anti-Botulinum Toxin Type B Antibody Titers

  Week 0 to Week 12

Study Arms (1)

Vaccine

EXPERIMENTAL

rBV A/B

Biological: rBV A/B

Interventions

rBV A/B BIOLOGICAL

Recombinant Botulinum Vaccine A/B, rBV A/B

Vaccine

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Are 18 to 69 years old at the time of consent
• Are healthy and have an acceptable medical history (defined as individuals who are free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, infective, muscular, infectious, rheumatic, immunological, or psychiatric diseases, as determined at screening) that will not interfere with the objectives of the study
• Meet the participant suitability requirements and recommendations for source plasma donors
• Participants of childbearing potential:
• Must have negative pregnancy test at screening and within 24 hours prior to vaccination.
• Must agree to not become pregnant until after the last plasma donation or until after the Week 12 visit (whichever occurs last).
• Must agree to use at least one form of highly effective birth control starting 30 days prior to rBV A/B administration through the end of the study. Acceptable forms of contraception include intrauterine device, birth control pills, injectable birth control, implantable birth control device, or any other U.S. FDA approved contraceptive method or a monogamous relationship with partner who has been vasectomized for at least 6 months prior to participant's enrollment or sexual abstinence.
• To be considered of non-childbearing potential, participants must be menopausal (no menstrual period for at least 12 months prior to screening) or be surgically sterile
• Are able 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 appropriate Institutional Review Board (IRB), and have agreed to abide by the study restrictions and return for the required assessments
• Agree to complete the participant home diary on a daily basis for 7 days post vaccination, as well as to report any severe adverse events (AEs) and serious AEs (SAEs), including serious new onset chronic illnesses (NOCIs) and concomitant medications during the study period
• Have provided written authorization for use and disclosure of protected health information
• 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)
• Have personal health insurance

You may not qualify if:

• Are pregnant or nursing
• 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)
• Have had a prior severe (Grade 3 or higher) local or severe (Grade 3 or higher) systemic reaction to last immunization with PBT
• Have had a prior severe immediate hypersensitivity reaction or severe systemic reaction on Day 0 to last vaccination with rBV A/B
• Have known allergy to aluminum, yeast, or other components of the vaccine
• Have donated one or more units of blood or undergone plasmapheresis within 49 days prior to enrollment
• Have received a blood product or immunoglobulin within 6 months prior to enrollment 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)
• Have received licensed nonliving vaccine within 14 days prior to enrollment, or licensed live vaccine within 60 days prior to enrollment
• Have received nonliving vaccine authorized for emergency use only within 14 days prior to enrollment, or living vaccine authorized for emergency use only within 60 days prior to enrollment
• Have received prescription immunosuppressive or immunomodulatory agents, including parenteral, inhaled, or oral corticosteroids within 3 months of enrollment 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
• Have received cytotoxic therapy at any time in the previous 5 years before enrollment

Sponsors & Collaborators

• California Department of Public Health: lead

Study Sites (2)

California Department of Public Health

Richmond, California, 94804, United States

Location

Battelle Biomedical Research Center

West Jefferson, Ohio, 43162, United States

Location

MeSH Terms

Conditions

Botulism

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neuromuscular Junction Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurotoxicity Syndromes; Foodborne Diseases; Poisoning; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: July 9, 2024
• Primary Completion: June 2, 2025
• Study Completion: June 2, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)