Trial record 5 of 11 for:    nicvax

Antibody and Safety Study of 6 Doses of NicVAX in Smokers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00598325
First received: January 9, 2008
Last updated: May 8, 2012
Last verified: May 2012
  Purpose

Prior clinical trials examined several schedules of a nicotine vaccine (NicVAX) for anti-nicotine antibody responses, and their impact on helping smokers quit. The best schedule so far has been one with doses at weeks 0, 4, 8, 16 and 26. This new study tests whether changing the schedule to weeks 0, 4, 8, 12 and 16 is an improvement for stimulating antibodies to nicotine. Routine vaccine safety information is also collected. Amendment 1 adds a 6th dose at week 26, and extends follow-up through week 52.


Condition Intervention Phase
Smoking
Biological: 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 2 Single Center, Open-label Study to Assess Immunogenicity and Safety of 6 Doses of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®)in Smokers

Further study details as provided by Nabi Biopharmaceuticals:

Primary Outcome Measures:
  • Anti-nicotine antibody concentration [ Time Frame: 12 time points between screening and week 20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vaccine reactogenicity [ Time Frame: for 7 days after each dose ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: for 30 weeks after 1st dose (4 wk after last dose) ] [ Designated as safety issue: Yes ]

Enrollment: 74
Study Start Date: January 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NicVAX Biological: 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)
1.0 ml injection IM given every 4 weeks (weeks 0, 4, 8, 12, 16)
Other Name: NicVAX
Experimental: NicVAX Lot 2
2nd cohort receives a different lot of vaccine from the 1st cohort
Biological: 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)
1.0 ml injection IM given every 4 weeks (weeks 0, 4, 8, 12, 16)
Other Name: NicVAX

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy smoker, ≥10 cigarettes per day for 6 months, exhaled carbon monoxide ≥10 ppm
  • Written informed consent
  • Negative urine pregnancy test, and willing to use birth control during the study, if applicable

Exclusion Criteria:

  • Prior exposure to nicotine vaccine
  • Clinically significant allergic reactions, especially to components of the vaccine
  • Serious or unstable clinical disease within the past 6 months
  • Use of any smoking cessation therapy within 30 days preceding 1st dose
  • Immunosuppression, due to: steroids or other immunosuppressants in the last 30 days, history of cancer or cancer treatment in the last 60 months, known HIV infection, or congenital or acquired immunodeficiency
  • Use of any vaccine other than influenza vaccine within 30 days prior to each study dose
  • Use of another IND drug or device within 30 days preceding 1st dose
  • Inability to follow the protocol, or illicit drug use in the past 12 months, or psychiatric disorder in the past 3 months
  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: NCT00598325

Locations
United States, Maryland
Accelovance, Inc.
Rockville, Maryland, United States, 20850
Sponsors and Collaborators
Nabi Biopharmaceuticals
Investigators
Study Director: Matt Hohenboken, MD, PhD Nabi Biopharmaceuticals
  More Information

No publications provided by Nabi Biopharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00598325     History of Changes
Other Study ID Numbers: Nabi-4513
Study First Received: January 9, 2008
Last Updated: May 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Nabi Biopharmaceuticals:
Nicotine
Vaccine
Immunogenicity
Tobacco
Habits

ClinicalTrials.gov processed this record on October 23, 2014