Smoking: Subjects must be smoking an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year. MedDRA version: 9.1 Level: LLT Classification code 10053325 Term: Smoking cessation therapy
Conditions
Interventions
Product Name: NicVAX
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Intramuscular use
Sponsors
ZonMw
nabi biopharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Male or female, 18 - 65 years of age, who has provided written, informed consent, and who, in the opinion of the investigator, is likely to comply with all the requirements of the study. b) Good general health. c) Subjects must be smoking an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year. d) If a female of child-bearing potential: a negative urine pregnancy test, and be willing to use acceptable birth control during study participation (oral, injectable, implantable contraceptive; intrauterine device; or barrier method with spermacide). e) Alveolar carbon monoxide level > 8 ppm. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Prior exposure to NicVAX or any other nicotine vaccine. b) Any known allergic reaction to any components of the vaccine c) Evidence or history of clinically significant allergic reactions (seasonal allergies allowed). d) Use of systemic steroids, immunosuppressive agents or other medications within 30 days prior to administration of investigational product that might interfere with an immune response. e) Known history of cancer or cancer treatment within 60 months prior to administration of investigational product, except for treated basal cell or squamous cell carcinoma. f) Known infection with HIV, or congenital or other acquired immunodeficiency. g) Known history of illicit drug or alcohol abuse or dependence (except nicotine) within 12 months prior to administration of investigational product and for the study duration. h) Known history of serious psychiatric disorder within 3 months prior to administration of investigational product. i) Required treatment for depression within the past 12 months. j) History of current psychosis or bipolar disorder. k) Current use of antidepressants, antipsychotics, mood stabilizers, naltrexone. l) Clinically significant cardiovascular disease within the past 6 months. m) Hepatic or renal impairment. n) Serious or unstable disease within the past 6 months, such as: - Uncontrolled hypertension. - Severe chronic obstructive pulmonary disease. - SGOT (AST) of SGPT (ALT) greater than 150% ULN or total bilirubin greater than 110% ULN. - Elevated serum creatinine. - Other clinically significant laboratory abnormality. o) Body mass index >38 [calculated as weight (kg)/height2 (m)] p) Known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder compliance. q) Use of any smoking cessation treatment, such as over the counter or prescription nicotine replacement therapy (NRT), varenicline, bupropion, clonidine, nortryptyline, mecamylamine within 30 days of the first administration of investigational product, or intention to participate in any other nicotine-related modification strategy outside the scope of this protocol. r) Intolerance to varenicline. s) Use of tobacco products other than cigarettes, including pipe tobacco, cigars, snuff, and chew, or marijuana use within the past month and not agreeing to abstain from use of these products during study participation. t) Use of Botox injections within 30 days prior to administration of investigational product and for the duration of the study. u) Use of any investigational vaccine 30 days prior to each administration of study product (licensed vaccines may be administered at any time with the exception of one week prior to and one week after administration of investigational product). v) Previous serious or unexpected adverse reaction to a vaccine, including Guillain-Barré syndrome. w) Anticipated inability to fulfill all visits and examination procedures throughout the study period (approximately 54 weeks). x) Receipt of an Investigational New Drug/Device 30 days prior to (or 5 half-lives, whichever is longer) administration of investigational product and for the duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of 400 ?g of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit.;Secondary Objective: • To evaluate safety and immunogenicity, • To evaluate long term abstinence from Week 37-52, • To evaluate four week abstinence from Week 9-12 • To evaluate abstinence from Week 37-52 for subjects who were intolerant to varenicline or who were non-abstinent from Week 9-12, • To evaluate point prevalence (7-day abstinence; PP) at 12, 26 and 52 weeks, • To evaluate relapse rate post week 12 among subjects with 4-week Continuous Abstinence status at 12 week. • To evaluate time to first Relapse among subjects with 4-week Continuous Abstinence status at 12 week, • To evaluate time to first Lapse among subjects with 4-week Continuous Abstinence status at 12 week. • To evaluate time between first Lapse and first Relapse among subjects with 4-week Continuous Abstinence status at 12 week, • To evaluate withdrawal symptoms using Minnesota Nicotine Withdrawal Scale, measured during Weeks 12-15, Weeks 26-29, and Weeks 49-52. ;Primary end point(s): • Long term abstinence from Week 9-52 confirmed by self-reported smoking and exhaled carbon monoxide (CO). | — |
Countries
Netherlands
Outcome results
None listed