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CLINICAL TRIALS Safety and Immunogenicity of a Nicotine Conjugate Vaccine in Current Smokers

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CLINICAL TRIALS Safety and Immunogenicity of a Nicotine Conjugate Vaccine in Current Smokers CLINICAL TRIALS Safety and immunogenicity of a nicotine conjugate vaccine in current smokers Immunotherapy is a novel potential treatment for nicotine addiction. The aim of this study was to assess the safety and immunogenicity of a nicotine conjugate vaccine, NicVAX, and its effects on smoking behavior. were recruited for a noncessation treatment study and assigned to 1 of 3 doses of the (68 ؍ Smokers (N nicotine vaccine (50, 100, or 200 ␮g) or placebo. They were injected on days 0, 28, 56, and 182 and monitored for a period of 38 weeks. Results showed that the nicotine vaccine was safe and well tolerated. Vaccine immunogenicity was dose-related (P < .001), with the highest dose eliciting antibody concentrations within the anticipated range of efficacy. There was no evidence of compensatory smoking or precipitation of nicotine withdrawal with the nicotine vaccine. The 30-day abstinence rate was significantly different across with the highest rate of abstinence occurring with 200 ␮g. The nicotine vaccine appears ,(02. ؍ the 4 doses (P to be a promising medication for tobacco dependence. (Clin Pharmacol Ther 2005;78:456-67.) Dorothy K. Hatsukami, PhD, Stephen Rennard, MD, Douglas Jorenby, PhD, Michael Fiore, MD, MPH, Joseph Koopmeiners, Arjen de Vos, MD, PhD, Gary Horwith, MD, and Paul R. Pentel, MD Minneapolis, Minn, Omaha, Neb, Madison, Wis, and Rockville, Md Surveys show that, although about 41% of smokers apy, is about 25% on average.2 Moreover, these per- make a quit attempt each year, less than 5% of smokers centages most likely exaggerate the efficacy of are successful at remaining abstinent for 3 months to a intervention because these trials are typically composed year.1 Smokers seeking available behavioral and phar- of subjects who are highly motivated to quit and who macologic therapies can enhance successful quit rates are free of complicating diagnoses such as depression 2 by 2- to 3-fold over control conditions. However, the or other psychiatric disorders.3 Because the vast major- rates of abstinence remain relatively low. In clinical ity of those who attempt to quit will not achieve pro- trials the long-term rate of abstinence by use of phar- longed abstinence, the need for better approaches to macologic treatments, with or without behavioral ther- smoking cessation is evident. The potential usefulness of vaccination as an inter- From the University of Minnesota Medical School, Cancer Center, Tobacco Use Research Center, and Minneapolis Medical Research vention for drug abuse was first demonstrated in an Foundation, Minneapolis; University of Nebraska Medical School, animal model by Bonese et al4 for heroin and was Omaha; University of Wisconsin Medical School, Center for To- subsequently extended in animal models to phencycli- bacco Research and Intervention, Madison; and Nabi Biopharma- dine, cocaine, methamphetamine (INN, metamfet- ceuticals, Rockville. This study was funded by National Institutes of Health grant U19 amine), and nicotine (see reference 5). V accination DA13327 and Nabi Biopharmaceuticals, as well as statistical sup- elicits the production of drug-specific antibodies that port from National Institutes of Health grant P50 DA013333. bind drug and reduce its distribution to the brain. Received for publication June 6, 2005; accepted Aug 9, 2005. Preclinical studies of short- and long-term adminis- Reprint requests: Dorothy K. Hatsukami, Tobacco Use Research Center, 2701 University Ave SE, Suite 201, Minneapolis, MN tration of clinically relevant doses of nicotine show 55414. that nicotine vaccines reduce the distribution of nic- E-mail: [email protected] otine to the brain in rats by up to 65%.6 Vaccination 0009-9236/$30.00 of rats or passive immunization with nicotine- Copyright © 2005 by the American Society for Clinical Pharmacology and Therapeutics. specific immunoglobulin G (IgG) has also been doi:10.1016/j.clpt.2005.08.007 shown to reduce nicotine discrimination, the devel- 456 CLINICAL PHARMACOLOGY & THERAPEUTICS 2005;78(5):456-67 Nicotine vaccine 457 opment of nicotine dependence, the reversal of nic- Table I. Time and events schedule otine abstinence signs by nicotine, the reinstatement Study day Events of nicotine self-administration, and the acquisition and maintenance of nicotine self-administration.7-11 Ϫ10 Baseline visit These data provide support for the hypothesis that 0 Baseline visit, injection 1 immunization can impact nicotine drug effects, in- 1 Safety evaluation 7, 14, 21 Clinic visits cluding those responsible for maintaining nicotine 28 Injection 2 addiction. 29 Safety evaluation The general concept of vaccination as a means of 35, 42, 49 Clinic visits blocking nicotine’s effects is attractive because of its 56 Injection 3 specificity. The antibody itself does not appreciably 57 Safety evaluation enter the brain so that central nervous system side 63, 70, 77, 98, 126, 154 Clinic visits effects are not expected. The antibodies elicited by 182 Injection 4 vaccination are highly specific for nicotine and do not 183 Safety evaluation bind other ligands, endogenous neurotransmitters, or 189, 203, 231, 266 Clinic visits receptors. Thus a vaccine against nicotine should not be associated with many of the adverse effects inherent to other pharmacologic treatments for drug abuse. Vacci- nation for nicotine dependence would then represent a screening was undertaken. If subjects met the initial unique addition to the available strategies for treating screening criteria, they were scheduled for an appoint- nicotine dependence. ment to obtain informed consent and to undergo a The primary aims of this study were to assess the comprehensive screening of their physical health. Ma- safety and immunogenicity of an investigational con- jor inclusion criteria for the study included the follow- jugate nicotine vaccine. Several concerns, such as the ing: (1) male subjects or female subjects who were not potential for compensatory smoking to overcome the of child-bearing potential and were aged at least 18 reduction in the reinforcing effects from smoking as a years, (2) subjects currently smoking at least 15 ciga- result of the binding of nicotine to antibody, as well as rettes per day (with alveolar carbon monoxide level of a precipitation of withdrawal symptoms after vaccina- Ͼ10 ppm), (3) a history of smoking for at least the past tion, have been raised regarding immunotherapy for 6 months without a period of abstinence for greater than smoking cessation.12 Therefore secondary objectives of 7 days and no intention to quit for the next 30 days, (4) the study were to assess withdrawal symptoms, the occurrence of compensatory smoking behavior, and good general health (ie, without significant medical change in tobacco use. Multiple administrations of 50, history, clinically significant physical examination 100, or 200 ␮g of a nicotine conjugate vaccine were findings, clinically significant electrocardiographic Ͻ delivered to current smokers in a study in which neither findings, or 1-second forced expiratory volume 75% Ͻ desire to quit nor willingness to make a quit attempt and forced expiratory vital capacity 80% of the pre- was required. dicted mean value for height, age, race, and gender), and (5) good mental health (ie, no history of alcohol or METHODS drug abuse or psychiatric history within the past 3 Subjects months). Major exclusion criteria were as follows: (1) A total enrollment of 63 subjects was planned, and any prior exposure to a nicotine vaccine or exposure to 68 subjects (15 women and 53 men) were enrolled from any other vaccine, except for influenza, 30 days before 3 research sites: University of Minnesota, Minneapolis, administration of study product; (2) allergy to alum or Minn (n ϭ 24); University of Wisconsin, Madison, Wis any components of the vaccine; (3) use of inhaled (n ϭ 21); and University of Nebraska, Omaha, Neb (n corticosteroids, systemic steroids, antihistamines, or ϭ 23). The 5 additional subjects replaced subjects who immunosuppressive agents within 30 days before the withdrew from the study within 1 month after the first study; and (4) use of any smoking cessation technique injection. All withdrawn subjects did so for non–safety- within 30 days of the screening visit. The study was related reasons. Each site recruited subjects through conducted under an Investigational New Drug applica- advertisements in newspapers or on the radio or tele- tion to the US Food and Drug Administration. The vision. Interested participants were asked to call the institutional review boards at the study sites approved research clinic, the study was explained, and an initial the study protocol and informed consent forms. CLINICAL PHARMACOLOGY & THERAPEUTICS 458 Hatsukami et al NOVEMBER 2005 Fig 1. Mean antibody concentration by nicotine vaccine dose over time. Arrows indicate vaccine injection times. IgG, Immunoglobulin G; ELISA, enzyme-linked immunosorbent assay. Study design smoking, they were informed to smoke as they felt This was a multicenter, randomized, double-blinded, comfortable. No behavioral counseling for cessation placebo-controlled, parallel-arm, dose-comparison was provided unless the participant indicated that they study. Participants were randomized to 1 of 3 treatment would like to quit smoking. If a study participant ex- groups, as follows: 50 ␮g vaccine or matching placebo, pressed a desire to quit, a standardized treatment pro- 100 ␮g vaccine or matching placebo, or 200 ␮g vaccine tocol was implemented, in which subjects received or matching placebo. Within each treatment
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