- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00764634
Double Blind, Safety and Immunogenicity Study of Recombinant Botulinum Vaccine A/B
November 28, 2011 updated by: DynPort Vaccine Company LLC, A GDIT Company
A Phase 2, Randomized, Double Blind, Placebo-Controlled, Multicenter Study to Evaluate Safety, Dosing Schedule and Antibody Kinetics of Recombinant Botulinum Vaccine A/B, rBV A/B-40, in Healthy Adults
This Phase 2 study is a double blind, placebo-controlled, randomized, multicenter investigation of rBV A/B-40 vaccine or placebo in healthy adults, using two different three-dose dosing schedules.
Study Overview
Status
Completed
Conditions
Detailed Description
The study includes 18 months (547 days) of follow-up after the first vaccination for all randomized volunteers who receive at least one vaccination.
Analysis of cumulative data collected through Day 547 ± 14 days will be reported in the final clinical study report.
Study Type
Interventional
Enrollment (Actual)
440
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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Florida
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Miami, Florida, United States, 33143
- Miami Research Associates
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Pembroke Pines, Florida, United States, 33024
- University Clinical Research, Inc
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Kansas
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Lenexa, Kansas, United States, 66219
- Johnson County Clin-Trials
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Missouri
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Kansas City, Missouri, United States, 64114
- Center for Pharmaceutical Research
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North Carolina
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Raleigh, North Carolina, United States, 27612
- Wake Research Associates
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Virginia
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Norfolk, Virginia, United States, 23507
- Clinical Research Associates of Tidewater
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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
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The volunteer has signed the informed consent form.
- The volunteer is 18 to 55 years of age.
- The volunteer agrees not to donate blood or blood product for therapeutic or research purposes.
- The volunteer is willing to comply with the requirements of the protocol.
- The volunteer has no clinically significant abnormalities on electrocardiogram.
- Female volunteers of childbearing potential must not be pregnant or lactating and agree to use two types of an acceptable form of FDA-approved contraception through Day 365 ± 7 days.
- The volunteer is in good health.
- The volunteer has clinical laboratory test results within the ranges listed in the protocol.
Exclusion Criteria:
- The volunteer has a history of botulism or prior receipt of any botulinum vaccine, toxoid or antitoxin.
- The volunteer has previously been treated or expects to be treated with any therapeutic products containing BoNTs such as Botox®, Myobloc®/Neurobloc™ and Botox® Cosmetic.
- The volunteer has a history of hypersensitivity or significant adverse reaction to other vaccines, aluminum compounds or yeast.
- The volunteer has donated one or more units of blood or undergone plasmapheresis within the past 28 days.
- The volunteer received any blood product or immunoglobulin in the previous 6 months.
- The volunteer received any investigational vaccine in the previous 6 months.
- The volunteer received any licensed nonliving vaccine within 14 days before or after a scheduled vaccination.
- The volunteer received any licensed live vaccine within 60 days before or after a scheduled vaccination.
- The volunteer received any investigational drug therapy within 30 days before the first vaccination or before the last scheduled visit.
- The volunteer received therapy with immunosuppressive agents, including use of moderate to high-dose oral inhaled or systemic corticosteroids (prednisone-equivalent dose of ≥ 20 mg/day).
- The volunteer had neurological conditions associated with spasticity or abnormal muscle contraction, demyelination, other abnormalities of smooth or skeletal muscle function, migraine headache, or hyperhidrosis.
- The volunteer had systemic or recurrent disease or condition that would place the volunteer at an unacceptable risk of injury or requires frequent or continuous medical intervention for treatment, has required hospitalization, or is likely to require surgical intervention during the course of the study.
- The volunteer has a history of immunodeficiency or autoimmune disease.
- The volunteer has a systemic medical condition that is ongoing or has required hospitalization or administration of antimicrobial agents within 6 months before screening.
- The volunteer has a history of arthritis on more than one occasion not related to trauma or any episode of non-trauma-related arthritis within the previous 6 months.
- The volunteer has an acute self-limited illness that has not resolved by the time of first vaccination including oral temperature greater than 99.5 °F.
- The volunteer has a history of abuse of alcohol or drugs within the 12 months before study screening.
- The volunteer has occupational or other responsibilities that would prevent completion of participation in the study.
- The volunteer has a body mass index ≥ 35 kg/m2.
- The volunteer has a confirmed positive result on a urine drug screen that tests for common substances of abuse such as amphetamines, barbiturates, benzodiazepines, cocaine, opiates and cannabinoids.
- The volunteer was seropositive on screening tests for human immunodeficiency virus, hepatitis C virus or hepatitis B surface antigen.
- The volunteer is currently on active duty in the U.S. military.
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 3 Placebo
|
0.5 mL dose of placebo given by intramuscular injection at Days 0, 28, and 182
Other Names:
0.5 mL dose of placebo given by intramuscular injection at Days 0, 56 and 182
Other Names:
|
Placebo Comparator: 1 Placebo
|
0.5 mL dose of placebo given by intramuscular injection at Days 0, 28, and 182
Other Names:
0.5 mL dose of placebo given by intramuscular injection at Days 0, 56 and 182
Other Names:
|
Active Comparator: 2 rBV A/B Vaccine
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0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 28 and 182
0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 56 and 182
Other Names:
|
Active Comparator: 4 rBV A/B Vaccine
|
0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 28 and 182
0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 56 and 182
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary safety objective is to assess rBV A/B-40 vaccine or placebo given to volunteers with an observation period of 30 weeks (Day 210 ± 7 days). The primary immunogenicity objective is to evaluate neutralizing antibody rate.
Time Frame: 30 weeks (Day 210 ± 7 days)
|
30 weeks (Day 210 ± 7 days)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The secondary safety objective is to assess rBV A/B-40 vaccine or placebo given to volunteers with an observation period of 18 months (Day 547 ± 14 days). The secondary immunogenicity objectives include evaluating antibody kinetics.
Time Frame: 18 months (Day 547 ± 14 days)
|
18 months (Day 547 ± 14 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: William Swiderski, DynPort Vaccine Company LLC
- Study Director: George A. Saviolakis, M.D., DynPort Vaccine Company LLC
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
September 1, 2008
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
September 30, 2008
First Submitted That Met QC Criteria
September 30, 2008
First Posted (Estimate)
October 2, 2008
Study Record Updates
Last Update Posted (Estimate)
December 2, 2011
Last Update Submitted That Met QC Criteria
November 28, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Nervous System Diseases
- Infections
- Neuromuscular Diseases
- Foodborne Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Neuromuscular Junction Diseases
- Clostridium Infections
- Poisoning
- Neurotoxicity Syndromes
- Botulism
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- rBV A/B-02
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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