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 |
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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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