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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00736047
First received: August 14, 2008
Last updated: October 29, 2009
Last verified: October 2009
  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 2

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Smoking status [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Exhaled carbon monoxide [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Smoking status at various time intervals from target quit date to the end of the study [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Immunogenicity (specific anti-nicotine antibodies in serum) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: August 2008
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Biological: NIC002
Placebo Comparator: 2 Biological: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

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

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Novartis Investigative Site
Mainz, Germany
Novartis Investigator Site
Neuss, Germany
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Novartis Investigator Site
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00736047     History of Changes
Other Study ID Numbers: CNIC002A2201
Study First Received: August 14, 2008
Last Updated: October 29, 2009
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:
Smokers
smoking cessation
vaccine
antibodies
anti-nicotine

ClinicalTrials.gov processed this record on September 30, 2014