Double Blind, Safety and Immunogenicity Study of Recombinant Botulinum Vaccine A/B
NCT ID: NCT00764634
Last Updated: 2011-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
440 participants
INTERVENTIONAL
2008-09-30
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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1 Placebo
Placebo (USP sterile saline for injection)
0.5 mL dose of placebo given by intramuscular injection at Days 0, 28, and 182
2 rBV A/B Vaccine
rBV A/B-40 vaccine
0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 28 and 182
3 Placebo
Placebo (USP sterile saline for injection)
0.5 mL dose of placebo given by intramuscular injection at Days 0, 56 and 182
4 rBV A/B Vaccine
rBV A/B-40 vaccine
0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 56 and 182
Interventions
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Placebo (USP sterile saline for injection)
0.5 mL dose of placebo given by intramuscular injection at Days 0, 28, and 182
rBV A/B-40 vaccine
0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 28 and 182
Placebo (USP sterile saline for injection)
0.5 mL dose of placebo given by intramuscular injection at Days 0, 56 and 182
rBV A/B-40 vaccine
0.5 mL dose of rBV A/B-40 vaccine given by intramuscular injection at Days 0, 56 and 182
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The volunteer is 18 to 55 years of age.
3. The volunteer agrees not to donate blood or blood product for therapeutic or research purposes.
4. The volunteer is willing to comply with the requirements of the protocol.
5. The volunteer has no clinically significant abnormalities on electrocardiogram.
6. 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.
7. The volunteer is in good health.
8. The volunteer has clinical laboratory test results within the ranges listed in the protocol.
Exclusion Criteria
2. 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.
3. The volunteer has a history of hypersensitivity or significant adverse reaction to other vaccines, aluminum compounds or yeast.
4. The volunteer has donated one or more units of blood or undergone plasmapheresis within the past 28 days.
5. The volunteer received any blood product or immunoglobulin in the previous 6 months.
6. The volunteer received any investigational vaccine in the previous 6 months.
7. The volunteer received any licensed nonliving vaccine within 14 days before or after a scheduled vaccination.
8. The volunteer received any licensed live vaccine within 60 days before or after a scheduled vaccination.
9. The volunteer received any investigational drug therapy within 30 days before the first vaccination or before the last scheduled visit.
10. 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).
11. 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.
12. 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.
13. The volunteer has a history of immunodeficiency or autoimmune disease.
14. The volunteer has a systemic medical condition that is ongoing or has required hospitalization or administration of antimicrobial agents within 6 months before screening.
15. 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.
16. 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.
17. The volunteer has a history of abuse of alcohol or drugs within the 12 months before study screening.
18. The volunteer has occupational or other responsibilities that would prevent completion of participation in the study.
19. The volunteer has a body mass index ≥ 35 kg/m2.
20. 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.
21. The volunteer was seropositive on screening tests for human immunodeficiency virus, hepatitis C virus or hepatitis B surface antigen.
22. The volunteer is currently on active duty in the U.S. military.
18 Years
55 Years
ALL
Yes
Sponsors
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DynPort Vaccine Company LLC, A GDIT Company
INDUSTRY
Responsible Party
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Principal Investigators
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William Swiderski
Role: STUDY_DIRECTOR
DynPort Vaccine Company LLC
George A. Saviolakis, M.D.
Role: STUDY_DIRECTOR
DynPort Vaccine Company LLC
Locations
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Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
Miami Research Associates
Miami, Florida, United States
University Clinical Research, Inc
Pembroke Pines, Florida, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
Center for Pharmaceutical Research
Kansas City, Missouri, United States
Wake Research Associates
Raleigh, North Carolina, United States
Countries
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Other Identifiers
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rBV A/B-02
Identifier Type: -
Identifier Source: org_study_id