NCT00598325

Antibody and Safety Study of 6 Doses of NicVAX in Smokers

Phase 2 Single Center, Open-label Study to Assess Immunogenicity and Safety of 6 Doses of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®)in Smokers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Nabi Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Prior clinical trials examined several schedules of a nicotine vaccine (NicVAX) for anti-nicotine antibody responses, and their impact on helping smokers quit. The best schedule so far has been one with doses at weeks 0, 4, 8, 16 and 26. This new study tests whether changing the schedule to weeks 0, 4, 8, 12 and 16 is an improvement for stimulating antibodies to nicotine. Routine vaccine safety information is also collected. Amendment 1 adds a 6th dose at week 26, and extends follow-up through week 52.

Conditions

• Smoking

Interventions

Type	Name	Description
BIOLOGICAL	3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)	1.0 ml injection IM given every 4 weeks (weeks 0, 4, 8, 12, 16)

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2008-01-21
• Last updated: 2012-05-09

Locations

1 site across 1 country: United States