Safety and Effectiveness of NicVAX in Treating Nicotine Dependent Individuals

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00218413

Enrollment

Registered

2005-09-22

Start date

2004-10-31

Completion date

2006-08-31

Last updated

2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation, Tobacco Use Cessation

Keywords

Vaccine, Immunogenicity, Randomized Controlled Trial, Addiction

Brief 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.

Detailed 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.

Interventions

BIOLOGICALNicVAX

100 μg, Formulation A, on Days 0, 21, 42, 91 & 182

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Anti-nicotine Antibody concentrations	19 time points from Day 0 to 365

Secondary

Measure	Time frame
Smoking cessation	periods of 2 weeks, 4 weeks, or 12 weeks duration
Fagerstrom Test for Nicotine Dependence	7 time points from Day 0 to 365
Safety: vaccine reactogenicity	7 days after each dose
Safety: adverse events	Day 0-365

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026