Immunogenicity and smoking-cessation outcomes for a novel nicotine immunotherapeutic

Autor: Stephen I. Rennard, Nancy A. Rigotti, David Gonzales, Raafat E F Fahim, Matthew W Kalnik, Douglas E. Jorenby, Elbert D. Glover, Dorothy K. Hatsukami, Donald P. Tashkin, Cheryl Oncken, Minoo Niknian, Victor I. Reus, Paul D. Kessler, Roxanne C. Akhavain
Rok vydání: 2011
Předmět:
Male
medicine.medical_treatment
cigarette
Gastroenterology
Nicotine
chemistry.chemical_compound
0302 clinical medicine
antibody
Pharmacology (medical)
Pharmacology & Pharmacy
media_common
0303 health sciences
Vaccines
Area under the curve
Pharmacology and Pharmaceutical Sciences
Tobacco Use Disorder
Middle Aged
3. Good health
CO
Treatment Outcome
NicVAX
Anesthesia
Area Under Curve
Female
Drug
medicine.drug
Adult
medicine.medical_specialty
media_common.quotation_subject
P. aeruginosa r-Exoprotein A
Placebo
Antibodies
Drug Administration Schedule
Article
Dose-Response Relationship
03 medical and health sciences
Double-Blind Method
Internal medicine
medicine
Humans
cotinine
030304 developmental biology
Pharmacology
Conjugate
Vaccines
Conjugate
Dose-Response Relationship
Drug
business.industry
aminomethyl nicotine
Abstinence
nicotine vaccine
smoking cessation
Regimen
3’AmNic-rEPA
chemistry
Smoking cessation
Smoking Cessation
nicotine immunotherapeutic
Cotinine
business
030217 neurology & neurosurgery
Zdroj: Clinical pharmacology and therapeutics
Clinical pharmacology and therapeutics, vol 89, iss 3
ISSN: 1532-6535
Popis: NicVAX, a nicotine vaccine (3'AmNic-rEPA), has been clinically evaluated to determine whether higher antibody (Ab) concentrations are associated with higher smoking abstinence rates and whether dosages and frequency of administration are associated with increased Ab response. This randomized, double-blinded, placebo-controlled multicenter clinical trial (N = 301 smokers) tested the results of 200- and 400-µg doses administered four or five times over a period of 6 months, as compared with placebo. 3'AmNic-rEPA recipients with the highest serum antinicotine Ab response (top 30% by area under the curve (AUC)) were significantly more likely than the placebo recipients (24.6% vs. 12.0%, P = 0.024, odds ratio (OR) = 2.69, 95% confidence interval (CI), 1.14-6.37) to attain 8 weeks of continuous abstinence from weeks 19 through 26. The five-injection, 400-µg dose regimen elicited the greatest Ab response and resulted in significantly higher abstinence rates than placebo. This study demonstrates, as proof of concept, that 3'AmNic-rEPA elicits Abs to nicotine and is associated with higher continuous abstinence rates (CAR). Its further development as a treatment for nicotine dependence is therefore justified.
Databáze: OpenAIRE
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