Nicotine Conjugate Vaccine as a Novel Approach to Smoking Cessation

Anne R. Ottney, Pharm.D

Pharmacotherapy. 2011;31(7):703-713.

Conclusion

The 3′-AmNic-rEPA vaccine represents a novel approach to smoking cessation through production of nicotine-specific antibodies that bind nicotine in the periphery, limiting distribution of nicotine to the brain and ultimately decreasing the reinforcing properties of cigarette smoking. Phase II clinical trials have demonstrated efficacy of the 3′-AmNic-rEPA vaccine in achieving smoking cessation, with higher vaccine doses showing greater efficacy. Awaiting results of phase III trials, the true clinical utility of the vaccine is yet to be realized, although the vaccine represents a distinctive administration model that may improve patient adherence and increase the ability to achieve abstinence from cigarette smoking.

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Table 1. Summary of Clinical Trials of the 3′-AmNic-rEPA Vaccine
Study Design, Duration	Study Population	Intervention	Primary Outcome	Results	Adverse Effects
Phase I–II, 38 wks19	Healthy men and women aged 24–60 yrs (n=30)	3′-AmNic-rEPA 100 μg i.m. or placebo given at baseline, 2 wks, 1 mo, and 6 mo	Immunogenicity and safety of multiple 100-μg doses of vaccine	Peak NSA level of 13.3 μg/ml in smokers and 4.4 μg/ml in nonsmokers achieved 1 wk after fourth injection in the vaccine group	Local: tenderness, ache, swelling, or induration at injection site Systemic: muscle ache, headache, bad taste, weight gain, general discomfort
Phase II, 38 wks^[14]	Men and women aged ≥ 18 yrs who smoked ≥ 15 cigarettes/day (n=68)	3′-AmNic-rEPA 50, 100, or 200 μg i.m. or placebo given at baseline and at 28, 56, and 182 days	Immunogenicity and safety of increasing doses of vaccine	Peak NSA level > 30 μg/ml 2 wks after third injection of 200 μg of vaccine; 30-day continuous smoking abstinence rate of 37.5% in abstinence rate of 37.5% in 200-μg vaccine group vs 8.7% in placebo group (not a primary end point)	Local: tenderness and ache at injection site Systemic: malaise, cough, headache, myalgias, upper respiratory infection, nasopharyngitis, myalgias
Phase IIb, 52 wks¹⁸	Men and women aged ≥ 18 yrs who smoked ≥ 15 cigarettes/day (n=301)	Group 1: 3′-AmNic-rEPA 200 or 400 μg i.m. or placebo given at baseline and at 6, 12, and 26 wks Group 2: 3′-AmNic-rEPA 200 or 400 μg i.m. or placebo given at baseline and at 4, 8, 16, and 26 wks	Continuous smoking abstinence rate from beginning of study wk 19 to end of study wk 26	High NSA responders achieved significantly greater 8-wk continuous abstinence rate compared with those in placebo group (24.6% vs 12%, p=0.024)	Local: tenderness and ache at injection site Systemic: malaise, headache, and myalgias
Two phase III (ongoing), 52 wks each^{20, 21}	Men and women aged 18–65 yrs who smoke ≥ 10 cigarettes/day (n=1000 in each trial)	3′-AmNic-rEPA 400 μg i.m. or placebo once/mo for 6 mo	Smoking abstinence at 12 mo	Not available	Not available

NSA = nicotine-specific antibody.

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Nicotine Conjugate Vaccine as a Novel Approach to Smoking Cessation

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