Clinical Trial: 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 Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: California Department of Public Health

Current Primary Outcome: Four-Fold Increase in Neutralizing Antibody Concentration (NAC) [ Time Frame: Week 0 to Week 4 ]

Proportion of participants achieving a four-fold or greater increase in NAC up to Week 4 compared with Week 0 for both botulinum toxin A and toxin B (a proportion ≥ 0.50 was considered a success).


Original Primary Outcome: Immunogenicity [ Time Frame: Baseline to 12 weeks ]

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.


Current Secondary Outcome:

  • Three-Fold Increase in Neutralizing Antibody Concentration (NAC) [ Time Frame: Week 0 to Week 4 ]
    Proportion of participants achieving a three-fold or greater increase in NAC up to Week 4 compared with Week 0 for both botulinum toxin A and toxin B (a proportion ≥ 0.50 was considered a success)
  • Two-Fold Increase in the Area Under the Neutralizing Antibody Concentration (NAC) Curve [ Time Frame: Week 0 to Week 12 ]
    Proportion of participants achieving a two-fold increase in the area under the plasma NAC-time curve between Week 0 and Week 12 in comparison with a straight-line extension of the Week 0 NAC to Week 12 for both botulinum toxin A and toxin B. A proportion ≥ 0.50 was considered a success.


Original Secondary Outcome:

  • Frequency and Severity of Adverse Events [ Time Frame: Baseline to 12 weeks ]
    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 ]
    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.


Information By: California Department of Public Health

Dates:
Date Received: October 3, 2012
Date Started: February 2013
Date Completion:
Last Updated: April 19, 2017
Last Verified: April 2017