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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Nabi Biopharmaceuticals |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00318383 |
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 |
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Smoking Cessation |
Biological: NicVAX conjugate vaccine Biological: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
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 |
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1: Experimental
200 mcg NicVAX in each of 4 doses
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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
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2: Experimental
200 mcg NicVAX in each of 5 doses
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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
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3: Experimental
400 mcg NicVAX in each of 4 doses
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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
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4: Experimental
400 mcg NicVAX in each of 5 doses
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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
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5: Placebo Comparator
Placebo in 4 or 5 doses
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Biological: Placebo
Phosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 4 or 5 doses over 6 months
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6: Experimental
200 mcg NicVAX formulation 2 in each of 5 doses
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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
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California | |
San Francisco, California, United States, 94143 | |
David Geffen School of Medicine at UCLA | |
Los Angeles, California, United States, 90095 | |
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 |
Study Director: | Matt Hohenboken, MD, PhD | Nabi Biopharmaceuticals |
Responsible Party: | Nabi Biopharmaceuticals ( Matt Hohenboken, MD, PhD, Executive Dir., Clinical & Medical Affairs ) |
Study ID Numbers: | Nabi - 4512, 1 R01 DA017894-01A1 |
Study First Received: | April 24, 2006 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00318383 |
Health Authority: | United States: Food and Drug Administration |
Vaccine Immunogenicity Randomized Controlled Trial |
Smoking Aluminum Hydroxide |
Habits |