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
  Purpose

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 Intervention Phase
Smoking
Biological: NicVAX Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Nabi Biopharmaceuticals:

Primary Outcome Measures:
  • Immunogenicity [ Time Frame: At Week 14 ] [ Designated as safety issue: No ]
    To compare imunogenicity of two lots by serum antibody concentration


Secondary Outcome Measures:
  • Safety [ Time Frame: Through Week 16 ] [ Designated as safety issue: Yes ]
    Assess safety by adverse events reported


Enrollment: 260
Study Start Date: May 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375933

Locations
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
Study Director: Medical Monitor Nabi Biopharmaceuticals
  More Information

No publications provided

Responsible Party: Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01375933     History of Changes
Other Study ID Numbers: Nabi-4516
Study First Received: June 15, 2011
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Nabi Biopharmaceuticals:
Smoking
NicVAX
Smoking vaccine

ClinicalTrials.gov processed this record on September 18, 2014