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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.
Information provided by (Responsible Party):
Nabi Biopharmaceuticals Identifier:
First received: June 15, 2011
Last updated: May 10, 2012
Last verified: May 2012
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
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

Resource links provided by NLM:

Further study details as provided by Nabi Biopharmaceuticals:

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

Secondary Outcome Measures:
  • Safety [ Time Frame: Through Week 16 ]
    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


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

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 identifier: NCT01375933

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
Study Director: Medical Monitor Nabi Biopharmaceuticals
  More Information

Responsible Party: Nabi Biopharmaceuticals Identifier: NCT01375933     History of Changes
Other Study ID Numbers: Nabi-4516
Study First Received: June 15, 2011
Last Updated: May 10, 2012

Keywords provided by Nabi Biopharmaceuticals:
Smoking vaccine

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs processed this record on September 20, 2017