Efficacy of NicVAX in Smokers Who Want to Quit Smoking

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Nabi Biopharmaceuticals
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00318383
First received: April 24, 2006
Last updated: November 3, 2008
Last verified: November 2008
  Purpose

The purpose of this study is to determine whether vaccination with NicVAX will result in a higher continuous abstinence rate than vaccination with placebo in smokers who want to quit smoking. In addition, two different formulations and dosing schedules will be studied, to select the dose and dosing schedule which generates the highest level of anti-nicotine antibodies. The primary study period is 12 months, which was extended by amendment to include up to 2 years of observations.


Condition Intervention Phase
Smoking Cessation
Biological: NicVAX conjugate vaccine
Biological: Placebo
Phase 2

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 2, Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Study to Assess Efficacy of 3'-Aminomethylnicotine-P.Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) in Smokers Who Want to Quit Smoking

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Continuous smoking abstinence [ Time Frame: 8 week interval (Weeks 19 to 26, inclusive, following the first vaccination) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Point prevalence abstinence [ Time Frame: at 12 months, and other time points; extended up to 24 months ] [ Designated as safety issue: No ]
  • Duration of smoking abstinence [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 0-12 months, and extended up to 24 months ] [ Designated as safety issue: Yes ]
  • Numbers of cigarettes per day [ Time Frame: Target quit day to 12 months ] [ Designated as safety issue: No ]
  • Cumulative number of cigarettes smoked [ Time Frame: during weeks 18-26 ] [ Designated as safety issue: No ]
  • Exhaled CO [ Time Frame: at clinic visits ] [ Designated as safety issue: No ]
  • Urine cotinine [ Time Frame: at clinic visits ] [ Designated as safety issue: No ]
  • Modified Minnesota Nicotine Withdrawal Questionnaire [ Time Frame: weekly for 6 months, daily for 14 days after quit attempt ] [ Designated as safety issue: Yes ]
  • Cigarette Evaluation Questionnaire (a.k.a. Nabi Questionnaire) [ Time Frame: weekly for 6 motnhs ] [ Designated as safety issue: Yes ]
  • Fagerstrom Test for Nicotine Dependence [ Time Frame: baseline, weeks 26 and 52 ] [ Designated as safety issue: No ]
  • serum anti-nicotine antibody concentrations by Elisa [ Time Frame: periodic from baseline to month 12, extended to month 24 ] [ Designated as safety issue: No ]

Enrollment: 313
Study Start Date: May 2006
Estimated Study Completion Date: November 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
200 mcg NicVAX in each of 4 doses
Biological: NicVAX conjugate vaccine
200 mcg or 400 mcg IM in 4 doses over 6 months; 200 mcg or 400 mcg IM in 5 doses over 6 months; 200 mcg (formulation 2) IM in 5 doses over 6 months; All are adsorbed onto Alhydrogel
Other Name: 3'-aminomethylnicotine-rEPA conjugate vaccine
Experimental: 2
200 mcg NicVAX in each of 5 doses
Biological: NicVAX conjugate vaccine
200 mcg or 400 mcg IM in 4 doses over 6 months; 200 mcg or 400 mcg IM in 5 doses over 6 months; 200 mcg (formulation 2) IM in 5 doses over 6 months; All are adsorbed onto Alhydrogel
Other Name: 3'-aminomethylnicotine-rEPA conjugate vaccine
Experimental: 3
400 mcg NicVAX in each of 4 doses
Biological: NicVAX conjugate vaccine
200 mcg or 400 mcg IM in 4 doses over 6 months; 200 mcg or 400 mcg IM in 5 doses over 6 months; 200 mcg (formulation 2) IM in 5 doses over 6 months; All are adsorbed onto Alhydrogel
Other Name: 3'-aminomethylnicotine-rEPA conjugate vaccine
Experimental: 4
400 mcg NicVAX in each of 5 doses
Biological: NicVAX conjugate vaccine
200 mcg or 400 mcg IM in 4 doses over 6 months; 200 mcg or 400 mcg IM in 5 doses over 6 months; 200 mcg (formulation 2) IM in 5 doses over 6 months; All are adsorbed onto Alhydrogel
Other Name: 3'-aminomethylnicotine-rEPA conjugate vaccine
Placebo Comparator: 5
Placebo in 4 or 5 doses
Biological: Placebo
Phosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 4 or 5 doses over 6 months
Experimental: 6
200 mcg NicVAX formulation 2 in each of 5 doses
Biological: NicVAX conjugate vaccine
200 mcg or 400 mcg IM in 4 doses over 6 months; 200 mcg or 400 mcg IM in 5 doses over 6 months; 200 mcg (formulation 2) IM in 5 doses over 6 months; All are adsorbed onto Alhydrogel
Other Name: 3'-aminomethylnicotine-rEPA conjugate vaccine

Detailed Description:

Cigarette smoking is responsible for over 400,000 (1 out of every 5) deaths in the United States each year. Most smokers are aware of the health consequences and want to quit, but have difficulty doing so. Only 3-5% of smokers who quit on their own are successful. Since the vast majority of those who attempt to quit will fail, the need for better approaches to smoking cessation is clear and urgent. A safe and effective means of blocking the effects of nicotine would be of considerable interest as a potential treatment for tobacco use. Vaccination to produce nicotine-specific antibodies may be viewed as an alternative method of blocking nicotine effects. Nicotine is a small molecule that does not elicit an immune response in animals of humans. In order for the immune system to respond to this hapten, nicotine can be combined or bound to a larger molecule in a unique manner so that an immune response is mounted against nicotine. Nabi Biopharmaceuticals has developed a conjugate vaccine (NicVAX) that consists of 3'-aminomethylnicotine bound to Pseudomonas aeruginosa exoprotein A, an exotoxin that has been made non-toxic by an amino acid deletion. Subjects will be randomized to one of four treatment groups.

Within each treatment group, 75 subjects will be randomized in a 2:1 ratio (NicVAX:Placebo), yielding a total of 50 active and 25 placebo subjects for each treatment group. There will be 12 subjects enrolled in a fifth open label arm to evaluate immunogenicity. A quit date will be set at the end of week 7 or at the end of week 5, depending on the dosing schedule. Continuous abstinence will be measured between the end of week 18 and the end of week 26.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Smokes at least 15 cigarettes per day
  • Wants to quit smoking
  • Good general health
  • Negative pregnancy test prior to study entry
  • Carbon monoxide level greater than 10 ppm

Exclusion Criteria:

  • Prior exposure to NicVAX or any other nicotine vaccine
  • Known allergic reaction to alum or any of the components of the vaccine
  • Use of steroids, immunosuppressive agents or other medication that might interfere with an immune response
  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: NCT00318383

Locations
United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
University of California
San Francisco, California, United States, 94143
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
United States, Maryland
Department of Public & Community Health
College Park, Maryland, United States, 20742
United States, Massachusetts
Tobacco Research Center, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55414
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53711
Sponsors and Collaborators
Nabi Biopharmaceuticals
Investigators
Study Director: Matt Hohenboken, MD, PhD Nabi Biopharmaceuticals
  More Information

No publications provided by National Institute on Drug Abuse (NIDA)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Matt Hohenboken, MD, PhD, Executive Dir., Clinical & Medical Affairs, Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00318383     History of Changes
Other Study ID Numbers: Nabi - 4512, 1 R01 DA017894-01A1
Study First Received: April 24, 2006
Last Updated: November 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
Vaccine
Immunogenicity
Randomized Controlled Trial

ClinicalTrials.gov processed this record on October 19, 2014