Safety, Tolerability, and Immunogenicity Study of Investigational Recombinant Botulinum Vaccine A/B (rBV A/B) in Volunteers Previously Immunized With Investigational Pentavalent Botulinum Toxoid
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|