NCT00633321

Study of TA-NIC to Assess the Efficacy and Safety of the Vaccine as an Aid to Smoking Cessation

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose-Ranging Study of 100 or 250 μg of TA-NIC to Assess the Efficacy and Safety of the Vaccine as an Aid to Smoking Cessation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 522 (estimated)
• Sponsor: Celtic Pharma Development Services · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Over 1 billion people worldwide smoke, resulting in an estimated 4 million deaths annually from smoking-related disease.1 Persistent and long-term smoking leads to an increased risk of cardiovascular damage, respiratory disease, and a higher incidence of a variety of cancers; but for smokers who can quit there is an immediate and significant beneficial impact on their health and life expectancy. Cigarette smoking remains the leading preventable cause of death in the United States (US), accounting for approximately 1 of every 5 deaths (438,000 people) each year. This Phase 2 study will investigate the efficacy and tolerability of 2 doses of TA-NIC compared to placebo as an aid to smoking cessation in smokers who are motivated to quit.

Detailed description

This is a multicenter, double-blind, randomized, placebocontrolled, 3-arm, Phase 2 study evaluating the efficacy and safety of TA-NIC as an aid for smoking cessation in smokers motivated to quit within 12 weeks. At the start of the study, each subject will set a Target Quit Date, which must be within 12 weeks after first injection. Each subject will receive 7 injections (vaccinations) from Weeks 0 to 16. Subjects will be encouraged to follow a phased reduction in cigarette consumption leading up to the Target Quit Date. All vaccinated subjects will be offered a counseling session at each clinic visit and will be contacted by telephone at Weeks 1, 3, 5, 7, 9, 14, 18, and 21 to provide up to 10 minutes of support and counseling for their smoking cessation. Smoking cessation will be measured during a 4-week assessment period from Week 22 to Week 26. Smoking cessation will be defined as complete abstinence during this 4-week period. Subject follow-up will continue to Week 52.

Conditions

• Smoking

Interventions

Type	Name	Description
BIOLOGICAL	TA-NIC	TA-NIC vaccine will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.
BIOLOGICAL	Placebo	Placebo will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-12-01
• Completion: 2009-02-01
• First posted: 2008-03-12
• Last updated: 2011-06-08

Locations

9 sites across 1 country: United States