NicVAX/Placebo as an Aid for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

A 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00836199
• Other study ID #: Nabi-4514
• Secondary ID: NIH grant # 1 RC
• Status: Completed
• Phase: Phase 3
• First received: February 3, 2009
• Last updated: May 8, 2012
• Start date: October 2009
• Est. completion date: July 2011

Study information

• Verified date: May 2012
• Source: Nabi Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation
• Tobacco Cessation

Intervention

Biological:
• NicVAX vaccine
NicVAX vaccine given 6 times over 6 months
• Placebo vaccine
Placebo vaccine given 6 times over 6 months

Locations

Country	Name	City	State
United States	NicVAX Investigator	Baltimore	Maryland
United States	NicVAX Investigator	Boise	Idaho
United States	NicVAX Investigator	Boston	Massachusetts
United States	NicVAX Investigator	College Park	Maryland
United States	NicVAX Investigator	Denver	Colorado
United States	NicVAX Investigator	Draper	Utah
United States	NicVAX Investigator	Farmington	Connecticut
United States	NicVAX Investigator	Lexington	Kentucky
United States	NicVAX Investigator	Los Angeles	California
United States	NicVAX Investigator	Madison	Wisconsin
United States	NicVAX Investigator	Miami	Florida
United States	NicVAX Investigator	Minneapolis	Minnesota
United States	NicVAX Investigator	Newport Beach	California
United States	NicVAX Investigator	Norfolk	Virginia
United States	NicVAX Investigator	Omaha	Nebraska
United States	NicVAX Investigator	Portland	Oregon
United States	NicVAX Investigator	Raleigh	North Carolina
United States	NicVAX Investigator	Rochester	New York
United States	NicVAX Investigator	San Diego	California
United States	NicVAX Investigator	Seattle	Washington
United States	NicVAX Investigator	St. Petersburg	Florida
United States	NicVAX Investigator	Tucson	Arizona

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate NicVAX as an aid to smoking cessation for long term abstinence.		one year	No
Secondary	Evaluate abstinence rates at multiple intervals		multiple time points	No
Secondary	Evaluate safety and immunogenicity		mulitple time points	Yes
Secondary	Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence.		multiple time points	Yes