Efficacy and Safety of Nicotine-Qbeta Vaccine in Smokers

Cytos Biotechnology

Status and phase: Completed; Phase 2

Conditions: Smokers

Treatments: Biological: CYT002-NicQb

Study type: Interventional

Funder types: Industry

Identifiers

NCT00369616

CYT002-NicQb 02

Details and patient eligibility

About

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.

Enrollment: 341 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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341 participants in 2 patient groups, including a placebo group

NicQb vaccine

Experimental group

Treatment:

Biological: CYT002-NicQb

Placebo vaccine

Placebo Comparator group

Treatment:

Biological: CYT002-NicQb