- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01701999
Safety, Tolerability, and Immunogenicity Study of Investigational Recombinant Botulinum Vaccine A/B (rBV A/B) in Volunteers Previously Immunized With Investigational Pentavalent Botulinum Toxoid
April 19, 2017 updated by: California Department of Public Health
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 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 Overview
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Richmond, California, United States, 94804
- California Department of Public Health
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Ohio
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West Jefferson, Ohio, United States, 43162
- Battelle Biomedical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 69 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The volunteer has received pentavalent botulinum toxoid for occupational protection under BB IND 0161, with the previous pentavalent botulinum toxoid dose at least 6 months prior to the planned rBV A/B dose.
- The volunteer is between the ages of 18 and 69 years at the time of consent.
- The volunteer is healthy and has an acceptable medical history.
- The volunteer meets the subject suitability requirements and recommendations for source plasma donors (for Part 2 subjects only).
- The volunteer, if female and of childbearing potential, is not pregnant or lactating, and agrees to use an acceptable form of FDA-approved contraception for the duration of the study.
- The volunteer has the ability to understand the requirements of the study and provide informed consent.
- The volunteer agrees to complete the subject diary on a daily basis for 7 days post-vaccination and to report concomitant medication and adverse events during the study period.
- The volunteer provides written authorization for use and disclosure of protected health information.
- The volunteer agrees not to donate blood or blood products (outside of study procedures) during the course of the study.
- The volunteer has personal health insurance.
Exclusion Criteria:
- Be pregnant or nursing
- The volunteer has a history of laboratory evidence of syphilis, acquired immunodeficiency syndrome, Creutzfeldt-Jakob disease, or infection with human immunodeficiency viruses 1 or 2, human T cell lymphotropic virus 1, hepatitis B virus, or hepatitis C virus.
- The volunteer had prior severe local or severe systemic reaction to last immunization with pentavalent botulinum toxoid.
- The volunteer has a known allergy to aluminum compounds, yeast, or other components of the vaccine.
- The volunteer has donated one or more units of blood or undergone plasmapheresis within 28 days before screening.
- The volunteer has received a blood product or immunoglobulin within 6 months of screening or plans to receive such products during the study.
- The volunteer has received licensed nonliving vaccine within 14 days before study entry or licensed live vaccine within 60 days before study entry.
- The volunteer has received investigational products (drugs, biologics, vaccines, or implantable devices) 60 days prior to study entry or plans to receive experimental products at any time during the study.
- The volunteer has received prescription immunosuppressive or immunomodulatory agents, including parenteral, inhaled, or oral corticosteroids within 3 months before screening or plans on receiving such therapy at any time during the study with the exceptions (Subjects who have used prescription topical steroids may be enrolled 2 weeks after the therapy is completed; Intra-articular, bursal, or tendon injectable steroids are permitted; Any over-the-counter topical steroid use is permitted; Ophthalmic and intranasal steroids are permitted).
- The volunteer has received cytotoxic therapy at any time in the previous 5 years to study entry.
- The volunteer has an active systemic or recurrent disease that would place the subject at unacceptable risk of injury, require hospitalization, or require surgical intervention.
- The volunteer has a history of alcohol or drug abuse within 12 months before screening.
- The volunteer has past, present, or suspected illicit injection drug use.
- The volunteer has inflammatory, vasculitic, or rheumatic disease, including systemic lupus erythematosus, polymyalgia rheumatica, rheumatoid arthritis, or scleroderma.
- The volunteer has clinically recognized hepatic or renal insufficiency.
- The volunteer has uncontrolled hypertension.
- The volunteer has moderate to severe asthma, chronic obstructive pulmonary disease, or other significant pulmonary disease.
- The volunteer has a seizure disorder.
- The volunteer has moderate or severe illness or oral temperature of 100.4°F or greater within 3 days prior to immunization.
- The volunteer is determined by the investigator to be unsuitable for participation in this trial for any reason.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Vaccine
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Four-Fold Increase in Neutralizing Antibody Concentration (NAC)
Time Frame: Week 0 to Week 4
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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).
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Week 0 to Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Three-Fold Increase in Neutralizing Antibody Concentration (NAC)
Time Frame: Week 0 to Week 4
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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)
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Week 0 to Week 4
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Two-Fold Increase in the Area Under the Neutralizing Antibody Concentration (NAC) Curve
Time Frame: Week 0 to Week 12
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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.
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Week 0 to Week 12
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Collected Plasma Volume
Time Frame: Week 1 to Week 12
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Measurement of the volume of source plasma containing neutralizing antibodies against botulinum toxin type A and type B collected by plasmapheresis in Part 2.
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Week 1 to Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stephen S. Arnon, M.D., California Department of Public Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (ACTUAL)
June 1, 2015
Study Completion (ACTUAL)
October 1, 2015
Study Registration Dates
First Submitted
October 3, 2012
First Submitted That Met QC Criteria
October 4, 2012
First Posted (ESTIMATE)
October 5, 2012
Study Record Updates
Last Update Posted (ACTUAL)
May 16, 2017
Last Update Submitted That Met QC Criteria
April 19, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- rBV A/B-CL-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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