Winter 2007

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Nicotine vaccines for smoking cessation


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A recent emerging health technology bulletin summarizes information about vaccines that are under development for smoking cessation.

Submitted Article

The Canadian Agency for Drugs and Technologies in Health (CADTH) is an independent, not-for-profit agency funded by Canadian federal, provincial, and territorial governments to provide credible, impartial advice and evidence-based information about the effectiveness of drugs and other health technologies to Canadian health care decision makers. A recent emerging health technology bulletin summarizes information about vaccines that are under development for smoking cessation.

Cigarette smoking is the leading cause of preventable disease and death in the world. Smoking was responsible for an estimated 100 million deaths in the 20th century, and is expected to cause ten times that number in the current century. Smoking accounted for 16.6% of all deaths in Canada in 2002 – a total of 37,209 deaths. The direct and indirect costs of smoking in Canada have been estimated at $8 to $11 billion per year. Nicotine, the principal addictive agent in cigarettes, is a common addiction throughout the world. Existing smoking cessation therapies are only modestly effective.

Nicotine vaccines produce nicotine-specific antibodies that bind a substantial proportion of the nicotine molecules when they enter the bloodstream. The antibody-bound nicotine molecules are too large to cross the blood-brain barrier, thus preventing most of the nicotine from entering the brain and exerting its addictive effects. In immunized individuals, nicotine is also less available for metabolizing, which markedly slows its elimination. This may enable smokers to reduce their rate of smoking, as the effect of any nicotine that succeeds in entering the brain is prolonged. Other strategies and pharmacological aids that are currently available for smoking cessation achieve limited success.

Nicotine vaccines are still at the investigational stage and none have been licensed for use in Canada or elsewhere. NicVAXฎ received a fast-track designation from the US Food and Drug Administration (FDA) in February 2006. Trial results from the NicVAX phase 2 proof-of-concept and optimal-dosing study are expected in the late 2007. Celtic Pharma anticipates seeking FDA approval for TA-NIC in 2009. The bulletin summarizes the evidence on three nicotine vaccines that have reached phase 2 trials.

If a nicotine vaccine is licensed for smoking cessation, there will likely be significant demand from the public and health care providers. Given the considerable interest smokers have in quitting the habit, and the limited effectiveness of currently available options, many smokers may be anxious to try a new therapy, even if the likelihood of quitting remains somewhat modest. Efficacy may ultimately depend on development of vaccine formulations or dosing schedules that permit all vaccinated individuals to achieve high antibody levels. Vaccines also offer the convenience of avoiding daily dosing and, based on the limited preliminary evidence available, adverse effects appear to be relatively minor.

For the full bulletin or other reports of interest feel free to visit the CADTH website  or contact Cindy Mosher, CADTH Liaison Officer in Newfoundland and Labrador or phone: (709)-777-8740.

Quick Facts 

  • Cigarette smoking is the leading cause of preventable disease and death in the world.

  • Nicotine vaccines produce antibodies that bind nicotine, the chief addictive agent in cigarettes, and prevent it from entering the brain.

  • Early trials suggest nicotine vaccines are safe and well tolerated, but the duration of effect is unclear, and immunological response varies across recipients.

  • Nicotine vaccines have not yet been studied in phase 3 trials and the relative performance of different vaccines, alone or in combination with existing therapeutic options, is unknown.

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