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

Smokers Clinical Trial

Official title:

A Double Blind, Placebo-controlled, Multi-centre Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of Repeated s.c Administrations of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736047
• Other study ID #: CNIC002A2201
• Status: Completed
• Phase: Phase 2
• First received: August 14, 2008
• Last updated: March 17, 2017
• Start date: August 2008
• Est. completion date: October 2009

Study information

• Verified date: March 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Smokers

Intervention

Biological:
• NIC002

• Placebo

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigator Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking status		12 weeks
Primary	Exhaled carbon monoxide		12 weeks
Secondary	Smoking status at various time intervals from target quit date to the end of the study		52 weeks
Secondary	Safety and tolerability		52 weeks
Secondary	Immunogenicity (specific anti-nicotine antibodies in serum)		52 weeks

External Links

•   Study results for CNIC002A2201 from Novartis Clinical Trial Results Website