Safety, Tolerability, and Immunogenicity Study of Investigational Recombinant Botulinum Vaccine A/B (rBV A/B) in Volunteers Previously Immunized With Investigational Pentavalent Botulinum Toxoid
|ClinicalTrials.gov Identifier: NCT01701999|
Recruitment Status : Completed
First Posted : October 5, 2012
Results First Posted : February 9, 2017
Last Update Posted : May 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Botulism||Biological: rBV A/B||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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 Volunteers Previously Immunized With Pentavalent Botulinum Toxoid for Occupational Protection|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||October 2015|
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.
- 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).
- 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.
- Collected Plasma Volume [ Time Frame: Week 1 to Week 12 ]Measurement of the volume of source plasma containing neutralizing antibodies against botulinum toxin type A and type B collected by plasmapheresis in Part 2.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701999
|United States, California|
|California Department of Public Health|
|Richmond, California, United States, 94804|
|United States, Ohio|
|Battelle Biomedical Research Center|
|West Jefferson, Ohio, United States, 43162|
|Principal Investigator:||Stephen S. Arnon, M.D.||California Department of Public Health|