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

This study is not yet open for participant recruitment.

Verified by Novartis, August 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00736047

Purpose

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

Condition	Intervention	Phase
Smokers	Biological: NIC002 Biological: Placebo	Phase II

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Immunoglobulins Globulin, Immune Nicotine polacrilex Nicotine tartrate

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Novartis:

Primary Outcome Measures:

Secondary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	August 2008
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Biological: NIC002
2: Placebo Comparator	Biological: Placebo

Eligibility

Criteria

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:

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736047

Contacts

Contact: Novartis

+41 61 324 1111

Locations

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis

Novartis Investigator Site

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CNIC002A2201
Study First Received:	August 14, 2008
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00736047
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:

Smokers
smoking cessation
vaccine
antibodies
anti-nicotine

Study placed in the following topic categories:

Nicotine polacrilex
Smoking
Antibodies
Nicotine
Immunoglobulins

ClinicalTrials.gov processed this record on January 14, 2009