| 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 each20, 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 |
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