Trial record 5 of 11 for:    nicvax

Antibody and Safety Study of 6 Doses of NicVAX in 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. Identifier: NCT00598325
Recruitment Status : Completed
First Posted : January 21, 2008
Last Update Posted : May 9, 2012
Information provided by (Responsible Party):
Nabi Biopharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Smoking Biological: 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Anti-nicotine antibody concentration [ Time Frame: 12 time points between screening and week 20 ]

Secondary Outcome Measures :
  1. Vaccine reactogenicity [ Time Frame: for 7 days after each dose ]
  2. Adverse events [ Time Frame: for 30 weeks after 1st dose (4 wk after last dose) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00598325

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nabi Biopharmaceuticals Identifier: NCT00598325     History of Changes
Other Study ID Numbers: Nabi-4513
First Posted: January 21, 2008    Key Record Dates
Last Update Posted: May 9, 2012
Last Verified: May 2012

Keywords provided by Nabi Biopharmaceuticals:

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs