Safety, Tolerability, and Immunogenicity Study of Investigational Recombinant Botulinum Vaccine A/B (rBV A/B) in Volunteers Previously Immunized With Investigational Pentavalent Botulinum Toxoid
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Phase 2b, Two-part, Open-label, Uncontrolled Study to Evaluate Safety, Tolerability, and Immunogenicity of a Single 40-µg Dose of Recombinant Botulinum Vaccine A/B (rBV A/B) for the Production of BabyBIG® in Plasma Donors Previously Immunized With Pentavalent Botulinum Toxoid for Occupational Protection|
- Immunogenicity [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]The primary immunogenicity objective of this study is to evaluate the effects of a single dose of rBV A/B on the botulinum toxin types A and B neutralizing antibody concentration (NAC) over a 12-week period after receiving the rBV A/B vaccine in subjects who have previously been immunized with PBT for occupational protection.
- Frequency and Severity of Adverse Events [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: Yes ]The primary safety objective of this study is to obtain safety information over a 12 week period on the use of rBV A/B in a population of plasma donors previously immunized with PBT for occupational protection with a long-term safety assessment (phone call follow-up) at 6 months. The frequency and severity of adverse events will be summarized by system organ class and preferred term.
- Change in laboratory parameters from Baseline to 12 weeks [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: Yes ]Changes in hematology, serum chemistry, and urinalysis parameters from baseline to the end of the study will be examined and summarized from baseline to week 12. Laboratory abnormalities will be assessed for relatedness. Treatment-emergent changes from normal to abnormal values in key laboratory parameters will be identified.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Biological: rBV A/B
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.
|United States, California|
|California Department of Public Health|
|Richmond, California, United States, 94804|
|Principal Investigator:||Stephen S. Arnon, M.D.||California Department of Public Health|