Safety and Effectiveness of NicVAX in Treating Nicotine Dependent Individuals

Smoking Cessation Clinical Trial

Official title:

A Phase 2 Study to Assess Safety and Immunogenicity of Five Doses of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) Administered to Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218413
• Other study ID #: NIDA-17894-2
• Secondary ID: Nabi-4505R01-178
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: January 11, 2017
• Start date: October 2004
• Est. completion date: August 2006

Study information

• Verified date: November 2008
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics CommitteeUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Nicotine is highly addictive and many individuals are unable to quit smoking even with treatment. The purpose of this study is to determine the effectiveness of various doses of NicVAX in treating nicotine dependent individuals.

Description:

Tobacco use is the single leading preventable cause of death in the United States. Nicotine is an alkaloid that is derived from the tobacco plant responsible for the psychoactive and addictive effects of smoking. Immunotherapy may be useful in preventing and treating nicotine dependent individuals. NicVAX is a nicotine vaccine, a type of immunotherapy that may be effective in smoking cessation and preventing relapse to nicotine. The purpose of this study is to evaluate the safety and efficacy of various dosing levels and dosing frequencies of NicVAX in treating nicotine dependent individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Current smoker

• Good general health, including mental health

• Alveolar carbon monoxide level greater than or equal to 10 ppm

Exclusion Criteria:

• Prior exposure to NicVAX

• Known allergy to any of the components of NicVAX

• Use of any smoking cessation aide

• Pregnant or breastfeeding

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco Use Cessation

Intervention

Biological:
• NicVAX
100 µg, Formulation A, on Days 0, 21, 42, 91 & 182
• NicVAX
200 µg, Formulation A, on Days 0, 21, 42, 91 & 182
• NicVAX
200 µg, Formulation B, on Days 0, 21, 42m 91 & 182
• NicVAX
300 µg, Formulation B, on Days 0, 21, 42, 91 & 182
• NicVAX
400 µg, Formulation B, on Days 0, 21, 42, 91 & 182

Locations

Country	Name	City	State
Netherlands	University of Maastricht	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Nabi Biopharmaceuticals	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-nicotine Antibody concentrations		19 time points from Day 0 to 365	No
Secondary	Smoking cessation		periods of 2 weeks, 4 weeks, or 12 weeks duration	No
Secondary	Fagerstrom Test for Nicotine Dependence		7 time points from Day 0 to 365	No
Secondary	Safety: vaccine reactogenicity		7 days after each dose	Yes
Secondary	Safety: adverse events		Day 0-365	Yes