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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102114
• Other study ID #: Nabi-4515
• Status: Completed
• Phase: Phase 3
• First received: March 17, 2010
• Last updated: May 8, 2012
• Start date: March 2010
• Est. completion date: November 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: November 2011
• Est. primary completion date: November 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 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.

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 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	Annapolis	Maryland
United States	NicVAX Investigator	Brooksville	Florida
United States	NicVAX Investigator	Buffalo	New York
United States	NicVAX Investigator	Charleston	West Virginia
United States	NicVAX Investigator	Cincinnati	Ohio
United States	NicVAX Investigator	Denver	Colorado
United States	NicVAX Investigator	East Lansing	Michigan
United States	NicVAX Investigator	Encino	California
United States	NicVAX Investigator	Houston	Texas
United States	NicVAX Investigator	Indianapolis	Indiana
United States	NicVAX Investigator	Jackson	Mississippi
United States	NicVAX Investigator	Knoxville	Tennessee
United States	NicVAX Investigator	Los Alamitos	California
United States	NicVAX Investigator	Metairie	Louisiana
United States	NicVAX Investigator	Milford	Massachusetts
United States	NicVAX Investigator	Mt. Pleasant	South Carolina
United States	NicVAX Investigator	Nashville	Tennessee
United States	NicVAX Investigator	New Haven	Connecticut
United States	NicVAX Investigator	Omaha	Nebraska
United States	NicVAX Investigator	Orlando	Florida
United States	NicVAX Investigator	Pembroke Pines	Florida
United States	NicVAX Investigator	Rochester	Minnesota
United States	NicVAX Investigator	Salt Lake City	Utah
United States	NicVAX Investigator	Tampa	Florida
United States	NicVAX Investigator	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Nabi Biopharmaceuticals

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 (by subject self-report and carbon monoxide confirmation).		One year	No
Secondary	Evaluate abstinence rates at multiple intervals (by subject self-report and carbon monoxide confirmation).		One year	No
Secondary	Evaluate safety based on adverse events.		One year	Yes
Secondary	Evaluate immunology based on serum antibody concentration.		One year	No
Secondary	Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence (based on subject self-report).		One year	Yes