Clinical trial NCT01102114: A Second Study of NicVAX/Placebo as an Aid for Smoking Cessation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Keywords: Smoking Cessation
NicVAX
Smoking Vaccine
Smoking Abstinence
Smoking
Tobacco Cessation
Lead sponsor: Nabi Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-04-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate NicVAX as an aid to smoking cessation for long term abstinence (by subject self-report and carbon monoxide confirmation).
timeFrame: One year
Secondary outcomes:
measure: Evaluate abstinence rates at multiple intervals (by subject self-report and carbon monoxide confirmation).
timeFrame: One year
measure: Evaluate safety based on adverse events.
timeFrame: One year
measure: Evaluate immunology based on serum antibody concentration.
timeFrame: One year
measure: Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence (based on subject self-report).
timeFrame: One year
Other outcomes:
Locations:
city: Encino
country: United States
facility: NicVAX Investigator
state: California
city: Los Alamitos
country: United States
facility: NicVAX Investigator
state: California
city: Denver
country: United States
facility: NicVAX Investigator
state: Colorado
city: New Haven
country: United States
facility: NicVAX Investigator
state: Connecticut
city: Brooksville
country: United States
facility: NicVAX Investigator
state: Florida
city: Orlando
country: United States
facility: NicVAX Investigator
state: Florida
city: Pembroke Pines
country: United States
facility: NicVAX Investigator
state: Florida
city: Tampa
country: United States
facility: NicVAX Investigator
state: Florida
city: Indianapolis
country: United States
facility: NicVAX Investigator
state: Indiana
city: Wichita
country: United States
facility: NicVAX Investigator
state: Kansas
city: Metairie
country: United States
facility: NicVAX Investigator
state: Louisiana
city: Annapolis
country: United States
facility: NicVAX Investigator
state: Maryland
city: Milford
country: United States
facility: NicVAX Investigator
state: Massachusetts
city: East Lansing
country: United States
facility: NicVAX Investigator
state: Michigan
city: Rochester
country: United States
facility: NicVAX Investigator
state: Minnesota
city: Jackson
country: United States
facility: NicVAX Investigator
state: Mississippi
city: Omaha
country: United States
facility: NicVAX Investigator
state: Nebraska
city: Buffalo
country: United States
facility: NicVAX Investigator
state: New York
city: Cincinnati
country: United States
facility: NicVAX Investigator
state: Ohio
city: Mt. Pleasant
country: United States
facility: NicVAX Investigator
state: South Carolina
city: Knoxville
country: United States
facility: NicVAX Investigator
state: Tennessee
city: Nashville
country: United States
facility: NicVAX Investigator
state: Tennessee
city: Houston
country: United States
facility: NicVAX Investigator
state: Texas
city: Salt Lake City
country: United States
facility: NicVAX Investigator
state: Utah
city: Charleston
country: United States
facility: NicVAX Investigator
state: West Virginia
Study officials:
affiliation: Nabi Biopharmaceuticals
name: Medical Monitor
role: STUDY_DIRECTOR
References: