Tolerability and Immunogenicity of rBV A/B for the Production of BabyBIG®

NCT03676634 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: rBV A/B-CL-002
• Study Type: interventional
• Target: 32
• 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 Greater Than 3- or 4-Fold Increases in Neutralizing Antibody Concentration (NAC)

  Neutralizing Antibody Concentration in Plasma

  Week 0 to Week 4

Secondary Outcomes (1)

• Proportion of Subjects Achieving Greater Than 2-Fold Increase in Neutralizing Antibody Concentration (NAC)

  Week 0 to 12

Other Outcomes (1)

• Volume of Plasma Collected With an Acceptable Anti-type A or Anti-type B Titer

  Week 0 to 4

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)
• Be 18 to 69 years old at the time of consent
• Be healthy and have an acceptable medical history that will not interfere with the objectives of the study
• Meet the participant suitability requirements and recommendations for source plasma donors outlined in Appendix A.
• 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 (\[whichever occurs last\].
• 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
• 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
• 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:

• Be 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 pentavalent botulinum toxoid or a prior severe immediate hypersensitivity reaction or severe systemic reaction to last vaccination on Day 0 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 of the Vaccination Visit (Day 0)
• 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)
• Have received licensed nonliving vaccine within 14 days prior to study entry, or licensed live vaccine within 60 days prior to study entry
• 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)
• 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
• Have received cytotoxic therapy at any time in the previous 5 years before study entry
• 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.)

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

Results Point of Contact

• Title: Stephen S. Arnon, M.D., M.P.H., Chief, Infant Botulism Treatment and Prevention Program
• Organization: California Department of Public Health

Stephen.Arnon@cdph.ca.gov

510-231-7600

Study Officials

• Stephen Arnon, M.D., M.P.H.

  California Department of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: September 17, 2018
• First Posted: September 19, 2018
• Study Start: March 7, 2019
• Primary Completion: April 25, 2020
• Study Completion: July 3, 2020
• Last Updated: October 19, 2021
• Results First Posted: October 19, 2021

Record last verified: 2020-01

Locations

US (2)