Efficacy and Safety of Nicotine-Qbeta Vaccine in Smokers

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

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 Overview

• Status: Completed
• Conditions: Smokers
• Intervention / Treatment: Biological: CYT002-NicQb

• Study Type: Interventional
• Enrollment (Actual): 341
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • St. Gallen, Switzerland, 9007
    • Kantonsspital St. Gallen
  • Zuerich, Switzerland, 8029
    • Lungenzentrum Hirslandenklinik Zuerich
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • University Hospital Lausanne (CHUV)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NicQb vaccine	Biological: CYT002-NicQb
Placebo Comparator: Placebo vaccine	Biological: CYT002-NicQb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Abstinence from smoking defined as self-reported abstinence and confirmed by measurement of carbon monoxide in exhaled air less than 10ppm	Monthly up to month 6, and during follow-up at months 9 and 12
Immunogenicity of the vaccine, by measuring specific anti-nicotine IgG antibodies by ELISA	Baseline, monthly up to month 6, and months 9 and 12
Safety and tolerability by recording adverse events, injection site examinations, vital signs, standard clinical laboratory (serum chemistry, hematology)	Baseline, and at various times up to month 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Craving and withdrawal symptoms by Questionnaire on Smoking Urges and Wisconsin Withdrawal Scale	Baseline, monthly up to month 6

Collaborators and Investigators

• Sponsor: Cytos Biotechnology AG
• Investigators: Study Chair: Jacques Cornuz, Prof., Department of Medicine; University Hospital Lausanne, Switzeland; Principal Investigator: Thomas Cerny, Prof., Department of Medicine, Kantonsspital St. Gallen, Switzerland; Principal Investigator: Felix Jungi, MD, Department of Medicine, Kantonsspital St. Gallen, Switzerland; Principal Investigator: Karl Klingler, MD, Lung Center Hirslanden, Zuerich, Switzerland

Publications and helpful links

General Publications

• Cornuz J, Zwahlen S, Jungi WF, Osterwalder J, Klingler K, van Melle G, Bangala Y, Guessous I, Muller P, Willers J, Maurer P, Bachmann MF, Cerny T. A vaccine against nicotine for smoking cessation: a randomized controlled trial. PLoS One. 2008 Jun 25;3(6):e2547. doi: 10.1371/journal.pone.0002547.

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Primary Completion (Actual): March 1, 2005
• Study Completion (Actual): October 1, 2005

Study Registration Dates

• First Submitted: August 25, 2006
• First Submitted That Met QC Criteria: August 28, 2006
• First Posted (Estimate): August 29, 2006

Study Record Updates

• Last Update Posted (Estimate): November 15, 2010
• Last Update Submitted That Met QC Criteria: November 11, 2010
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Other Study ID Numbers: CYT002-NicQb 02