Trial | NCT00369616  Report issue

Title

Efficacy and Safety of Nicotine-Qbeta Vaccine in Smokers
Evaluation of Efficacy and Safety of Nicotine-Qbeta (NicQb) Vaccine Versus Placebo in Healthy Smokers

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    341
The purpose of this study is to help smokers quitting by vaccinating them with CYT002-NicQb. Upon vaccination, the smoker will generate antibodies directed against free nicotine. The antibodies will bind nicotine and prevent its passage into the brain. The successfully vaccinated smoker will have no reward effect after smoking, thus braking the vicious circle of nicotine addiction.
Study Started
Dec 31
2003
Primary Completion
Mar 31
2005
Study Completion
Oct 31
2005
Last Update
Nov 15
2010
Estimate

Biological CYT002-NicQb

NicQb vaccine Experimental

Placebo vaccine Placebo Comparator

Criteria 

Inclusion Criteria:

Written informed consent
Age 18 to 70 years
Smokers: > 10 and ≤ 40 cigarettes per day and smoking history of more than 3 years
Fageström Test for Nicotine Dependence (FTND) score ≥ 5
Female participant must meet one of the following criteria: a) no reproductive potential due to menopause, hysterectomy, bilateral oophorectomy, or tubal ligation; b) agrees to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 12 additional months after the last immunization

Exclusion Criteria:

Pregnant or nursing
History of severe allergy or immunological disorders
Blood donation within previous 30 days
Surgery within previous 30 days
Use of investigational drugs within previous 60 days

Significant cardiovascular disease:

angina pectoris
congestive heart failure
clinically significant murmurs
previous angioplasty or coronary artery bypass surgery

Active infectious disease:

WBC > 12 000 cells/µL
Seropositivity for Hepatitis B and C
History of risk behavior to acquire HIV
Significant hepatic disease
Significant renal disease
Significant hematological disorder
Significant pulmonary disease
History of malignancy
Autoimmune disease
Organic neurological disorder or significant psychiatric disorder
Use of psychoactive drug within one month before enrolment
Abuse of drugs or alcohol
Subjects using any concomitant medications due to chronic illness which bears a high risk of fluctuation in disease activity or exacerbations during a 12-months period such as coronary heart disease, asthma, severe COPD, chronic rheumatoid disease, diabetes, etc. should be excluded.
Obesity: BMI > 35 kg/m2
Use of concomitant nicotine replacement treatment (NRT) at screening or visit 1
Any planned surgical intervention during the study period
No Results Posted