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Safety, Tolerability, and Immunogenicity Study of Investigational Recombinant Botulinum Vaccine A/B (rBV A/B) in Volunteers Previously Immunized With Investigational Pentavalent Botulinum Toxoid

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
California Department of Public Health
ClinicalTrials.gov Identifier:
NCT01701999
First received: October 3, 2012
Last updated: April 19, 2017
Last verified: April 2017
Results First Received: December 15, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Other
Condition: Botulism
Intervention: Biological: rBV A/B

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Initial Safety and Immunogenicity (Part 1) Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
Safety, Immunogenicity, and Plasma Collection (Part 2) Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.

Participant Flow:   Overall Study
    Initial Safety and Immunogenicity (Part 1)   Safety, Immunogenicity, and Plasma Collection (Part 2)
STARTED   8   37 
COMPLETED   8   37 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Initial Safety and Immunogenicity (Part 1) Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
Safety, Immunogenicity, and Plasma Collection (Part 2) Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
Total Total of all reporting groups

Baseline Measures
   Initial Safety and Immunogenicity (Part 1)   Safety, Immunogenicity, and Plasma Collection (Part 2)   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   37   45 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.3  (13.5)   44.0  (10.7)   45.1  (11.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  37.5%      20  54.1%      23  51.1% 
Male      5  62.5%      17  45.9%      22  48.9% 


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

2.  Secondary:   Three-Fold Increase in Neutralizing Antibody Concentration (NAC)   [ Time Frame: Week 0 to Week 4 ]

3.  Secondary:   Two-Fold Increase in the Area Under the Neutralizing Antibody Concentration (NAC) Curve   [ Time Frame: Week 0 to Week 12 ]

4.  Other Pre-specified:   Collected Plasma Volume   [ Time Frame: Week 1 to Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Jessica Khouri
Organization: California Department of Public Health
phone: 510-231-7600
e-mail: Jessica.Khouri@cdph.ca.gov



Responsible Party: California Department of Public Health
ClinicalTrials.gov Identifier: NCT01701999     History of Changes
Other Study ID Numbers: rBV A/B-CL-001
Study First Received: October 3, 2012
Results First Received: December 15, 2016
Last Updated: April 19, 2017