Efficacy and Safety of Nicotine-Qbeta Vaccine in Smokers

NCT ID: NCT00369616

Last Updated: 2010-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 341 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2005-10-31

Brief Summary

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.

Conditions

Smokers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NicQb vaccine

Group Type: EXPERIMENTAL

CYT002-NicQb

Intervention Type: BIOLOGICAL

Placebo vaccine

Group Type: PLACEBO_COMPARATOR

CYT002-NicQb

Intervention Type: BIOLOGICAL

Interventions

CYT002-NicQb

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cytos Biotechnology AG

INDUSTRY

Sponsor Role: lead

Principal Investigators

Jacques Cornuz, Prof.

Role: STUDY_CHAIR

Department of Medicine; University Hospital Lausanne, Switzeland

Thomas Cerny, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Kantonsspital St. Gallen, Switzerland

Felix Jungi, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Kantonsspital St. Gallen, Switzerland

Karl Klingler, MD

Role: PRINCIPAL_INVESTIGATOR

Lung Center Hirslanden, Zuerich, Switzerland

Locations

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

University Hospital Lausanne (CHUV)

Lausanne, Canton of Vaud, Switzerland

Lungenzentrum Hirslandenklinik Zuerich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 18575629 (View on PubMed)

Other Identifiers

CYT002-NicQb 02

Identifier Type: -

Identifier Source: org_study_id