A Second Study of NicVAX/Placebo as an Aid for Smoking Cessation

A Second Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy, Immunogenicity and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) as an Aid to Smoking Cessation

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01102114

Enrollment

1000

Registered

2010-04-12

Start date

2010-03-31

Completion date

2011-11-30

Last updated

2012-05-09

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

Conditions

Smoking Cessation

Keywords

Smoking Cessation, NicVAX, Smoking Vaccine, Smoking Abstinence, Smoking, Tobacco Cessation

Brief summary

The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.

Interventions

BIOLOGICALNicVAX Vaccine

NicVAX vaccine given 6 times over 6 months

BIOLOGICALPlacebo Vaccine

Placebo vaccine given 6 times over 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Current smoker who smokes at least 10 cigarettes a day during the past year and wants to quit smoking. * Smokers who are in good general health.

Exclusion criteria

* Prior exposure to NicVAX or any other nicotine vaccine. * Use of systemic steroids. * Cancer or cancer treatment in the last 5 years. * HIV infection. * History of drug or alcohol abuse or dependence within 12 months. * Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease. * Inability to fulfill all visits for approximately 52 weeks.

Design outcomes

Primary

Measure	Time frame
Evaluate NicVAX as an aid to smoking cessation for long term abstinence (by subject self-report and carbon monoxide confirmation).	One year

Secondary

Measure	Time frame
Evaluate abstinence rates at multiple intervals (by subject self-report and carbon monoxide confirmation).	One year
Evaluate safety based on adverse events.	One year
Evaluate immunology based on serum antibody concentration.	One year
Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence (based on subject self-report).	One year

Countries

United States

Outcome results

None listed

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