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A Comparability Study of the Phase 3 Lot and a Single Commercial Lot of NicVAX in Healthy Adult Smokers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01375933
First received: June 15, 2011
Last updated: May 10, 2012
Last verified: May 2012
History of Changes

June 15, 2011
May 10, 2012
May 2011
October 2011   (final data collection date for primary outcome measure)
Immunogenicity [ Time Frame: At Week 14 ] [ Designated as safety issue: No ]
To compare imunogenicity of two lots by serum antibody concentration
Same as current
Complete list of historical versions of study NCT01375933 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: Through Week 16 ] [ Designated as safety issue: Yes ]
Assess safety by adverse events reported
Safety [ Time Frame: Through Week 30 ] [ Designated as safety issue: Yes ]
Assess safety by adverse events reported
Not Provided
Not Provided
 
A Comparability Study of the Phase 3 Lot and a Single Commercial Lot of NicVAX in Healthy Adult Smokers
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Smoking
Biological: NicVAX Vaccine
NicVAX Vaccine given 6 times over 6 months
  • Active Comparator: NicVAX - Phase 3 Lot
    NicVAX - Phase 3 Lot
    Intervention: Biological: NicVAX Vaccine
  • Active Comparator: NicVAX - Commercial Lot
    NicVAX - Commercial Lot
    Intervention: Biological: NicVAX Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
260
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01375933
Nabi-4516
No
Nabi Biopharmaceuticals
Nabi Biopharmaceuticals
Not Provided
Study Director: Medical Monitor Nabi Biopharmaceuticals
Nabi Biopharmaceuticals
May 2012

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