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Double Blind, Safety and Immunogenicity Study of Recombinant Botulinum Vaccine A/B

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ClinicalTrials.gov Identifier: NCT00764634
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : December 2, 2011
Sponsor:
Information provided by (Responsible Party):
DynPort Vaccine Company LLC, A GDIT Company

Tracking Information
First Submitted Date  ICMJE September 30, 2008
First Posted Date  ICMJE October 2, 2008
Last Update Posted Date December 2, 2011
Study Start Date  ICMJE September 2008
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00764634 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Double Blind, Safety and Immunogenicity Study of Recombinant Botulinum Vaccine A/B
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Condition  ICMJE Botulism Vaccine
Intervention  ICMJE
  • Biological: Placebo (USP sterile saline for injection)
    0.5 mL dose of placebo given by intramuscular injection at Days 0, 28, and 182
    Other Name: placebo
  • Biological: 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
  • Biological: Placebo (USP sterile saline for injection)
    0.5 mL dose of placebo given by intramuscular injection at Days 0, 56 and 182
    Other Name: placebo
  • Biological: 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 Name: rBV A/B vaccine
Study Arms  ICMJE
  • Placebo Comparator: 1 Placebo
    Intervention: Biological: Placebo (USP sterile saline for injection)
  • Active Comparator: 2 rBV A/B Vaccine
    Intervention: Biological: rBV A/B-40 vaccine
  • Placebo Comparator: 3 Placebo
    Intervention: Biological: Placebo (USP sterile saline for injection)
  • Active Comparator: 4 rBV A/B Vaccine
    Intervention: Biological: rBV A/B-40 vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2008)
440
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The volunteer has signed the informed consent form.
  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:

  1. The volunteer has a history of botulism or prior receipt of any botulinum vaccine, toxoid or antitoxin.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00764634
Other Study ID Numbers  ICMJE rBV A/B-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party DynPort Vaccine Company LLC, A GDIT Company
Study Sponsor  ICMJE DynPort Vaccine Company LLC, A GDIT Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: William Swiderski DynPort Vaccine Company LLC
Study Director: George A. Saviolakis, M.D. DynPort Vaccine Company LLC
PRS Account DynPort Vaccine Company LLC, A GDIT Company
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP