Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.

Phase 2

Completed

• Conditions: Smokers

• Registration Number: NCT00736047
• Lead Sponsor: Novartis

Brief Summary

This study is designed to determine the efficacy of high nicotine-specific antibody titers in smoking cessation.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-14
• Study First Submitted QC: 2008-08-14
• Study First Posted: 2008-08-15
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-17
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Healthy male and female smoking subjects age 18 to 65 years of age
• Subjects must be smoking 10 or more cigarettes per day during the past 12 months
• The exhaled breath carbon monoxide (CO) concentration must be 10 ppm or more at screening. Urine cotinine at screening must be positive.
• The Fagerström Test for Nicotine Dependence (FTND) score of 5 or above at screening.

Exclusion Criteria

• Attempted to quit smoking in the three (3) months.
• Prior use of smoking cessation aid.

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Smoking status	12 weeks
Exhaled carbon monoxide	12 weeks

Secondary Outcome Measures

Name	Time	Method
Smoking status at various time intervals from target quit date to the end of the study	52 weeks
Safety and tolerability	52 weeks
Immunogenicity (specific anti-nicotine antibodies in serum)	52 weeks

Trial Locations

Locations (2)

Novartis Investigative Site; 🇩🇪 Mainz, Germany

Novartis Investigator Site; 🇩🇪 Neuss, Germany