Efficacy and Safety of Nicotine-Qbeta Vaccine in Smokers

Smokers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00369616
• Other study ID #: CYT002-NicQb 02
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2006
• Last updated: November 11, 2010
• Start date: December 2003
• Est. completion date: October 2005

Study information

• Verified date: March 2008
• Source: Cytos Biotechnology AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: October 2005
• Est. primary completion date: March 2005
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smokers

Intervention

Biological:
• CYT002-NicQb

Locations

Country	Name	City	State
Switzerland	University Hospital Lausanne (CHUV)	Lausanne	Vaud
Switzerland	Kantonsspital St. Gallen	St. Gallen
Switzerland	Lungenzentrum Hirslandenklinik Zuerich	Zuerich

Sponsors (1)

Lead Sponsor	Collaborator
Cytos Biotechnology AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Immunogenicity of the vaccine, by measuring specific anti-nicotine IgG antibodies by ELISA		Baseline, monthly up to month 6, and months 9 and 12	No
Primary	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	Yes
Secondary	Craving and withdrawal symptoms by Questionnaire on Smoking Urges and Wisconsin Withdrawal Scale		Baseline, monthly up to month 6	No