Efficacy of NicVAX in Smokers Who Want to Quit Smoking

Completed · Phase 2 · Has a placebo group

Conditions studied: Smoking Cessation

In brief

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.

Key facts

Study ID

NCT00318383

Run by

National Institute on Drug Abuse (NIDA)

People needed

313

Starts

2006-05-01

Expected to finish

2007-12-01

Last updated by the study team

2017-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• University of California — San Francisco, California, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• Department of Public & Community Health — College Park, Maryland, United States
• Tobacco Research Center, Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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