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Trial record 1 of 48 for:    smoking vaccine
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A Comparability Study of the Phase 3 Lot and a Single Commercial Lot of NicVAX in Healthy Adult Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01375933
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : May 14, 2012
Sponsor:
Information provided by (Responsible Party):
Nabi Biopharmaceuticals

Study Description
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Brief Summary:
The purpose of this study is to assess the comparability of the phase 3 lot and a single commercial lot of NicVAX in healthy smokers.

Condition or disease Intervention/treatment Phase
Smoking Biological: NicVAX Vaccine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Double-Blinded, Randomized, Study to Assess Comparability of a Single Phase 3 Lot and a Single Commercial Lot of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) in Healthy Adult Smokers
Study Start Date : May 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: NicVAX - Phase 3 Lot
NicVAX - Phase 3 Lot
 Biological: NicVAX Vaccine
NicVAX Vaccine given 6 times over 6 months
Active Comparator: NicVAX - Commercial Lot
NicVAX - Commercial Lot
 Biological: NicVAX Vaccine
NicVAX Vaccine given 6 times over 6 months


Outcome Measures
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Primary Outcome Measures :
  1. Immunogenicity [ Time Frame: At Week 14 ]
    To compare imunogenicity of two lots by serum antibody concentration


Secondary Outcome Measures :
  1. Safety [ Time Frame: Through Week 16 ]
    Assess safety by adverse events reported


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female smokers, age 18-55, who are currently smoking at least 10 cigarettes per day.

Exclusion Criteria:

  • Prior exposure to NicVAX or any other nicotine vaccine.
  • History of clinically significant allergic reactions.
  • Use of systemic steroids.
  • Cancer or cancer treatment within 5 years.
  • HIV infection.
  • History of drug or alcohol abuse or dependence.
  • Required treatment for depression within the past 12 months.
  • Body mass index ≥ 30 [calculated as weight (kg)/height2 (m)].
  • Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease.
  • Inability to fulfill all visits for approximately 30 weeks.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375933


Locations
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United States, Alabama
NicVAX Investigator
Huntsville, Alabama, United States, 35802
United States, California
NicVAX Investigator
San Diego, California, United States, 92018
United States, Florida
NicVAX Investigator
Melbourne, Florida, United States, 32935
United States, Illinois
NicVAX Investigator
Peoria, Illinois, United States, 61602
United States, Indiana
NicVAX Investigator
South Bend, Indiana, United States, 46601
United States, Maryland
NicVAX Investigator
Rockville, Maryland, United States, 20850
Sponsors and Collaborators
Nabi Biopharmaceuticals
Investigators
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Study Director: Medical Monitor Nabi Biopharmaceuticals
More Information
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Responsible Party: Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01375933    
Other Study ID Numbers: Nabi-4516
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012
Keywords provided by Nabi Biopharmaceuticals:
Smoking
NicVAX
Smoking vaccine