NCT00836199

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

May 9, 2012

Status Verified

May 1, 2012

Enrollment Period

1.7 years

First QC Date

February 3, 2009

Last Update Submit

May 8, 2012

Conditions

Smoking CessationSmokingTobacco Cessation

Keywords

smoking cessationNicVAXsmoking vaccinesmoking abstinencesmokingtobacco cessation

Outcome Measures

Primary Outcomes (1)

  • Evaluate NicVAX as an aid to smoking cessation for long term abstinence.

    one year

Secondary Outcomes (3)

  • Evaluate abstinence rates at multiple intervals

    multiple time points

  • Evaluate safety and immunogenicity

    mulitple time points

  • Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence.

    multiple time points

Study Arms (2)

Placebo vaccine

PLACEBO COMPARATOR
Biological: Placebo vaccine

NicVAX vaccine

EXPERIMENTAL
Biological: NicVAX vaccine

Interventions

NicVAX vaccineBIOLOGICAL

NicVAX vaccine given 6 times over 6 months

NicVAX vaccine
Placebo vaccineBIOLOGICAL

Placebo vaccine given 6 times over 6 months

Placebo vaccine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

NicVAX Investigator

Tucson, Arizona, United States

Location

NicVAX Investigator

Los Angeles, California, United States

Location

NicVAX Investigator

Newport Beach, California, United States

Location

NicVAX Investigator

San Diego, California, United States

Location

NicVAX Investigator

Denver, Colorado, United States

Location

NicVAX Investigator

Farmington, Connecticut, United States

Location

NicVAX Investigator

Miami, Florida, United States

Location

NicVAX Investigator

St. Petersburg, Florida, United States

Location

NicVAX Investigator

Boise, Idaho, United States

Location

NicVAX Investigator

Lexington, Kentucky, United States

Location

NicVAX Investigator

Baltimore, Maryland, United States

Location

NicVAX Investigator

College Park, Maryland, United States

Location

NicVAX Investigator

Boston, Massachusetts, United States

Location

NicVAX Investigator

Minneapolis, Minnesota, United States

Location

NicVAX Investigator

Omaha, Nebraska, United States

Location

NicVAX Investigator

Rochester, New York, United States

Location

NicVAX Investigator

Raleigh, North Carolina, United States

Location

NicVAX Investigator

Portland, Oregon, United States

Location

NicVAX Investigator

Draper, Utah, United States

Location

NicVAX Investigator

Norfolk, Virginia, United States

Location

NicVAX Investigator

Seattle, Washington, United States

Location

NicVAX Investigator

Madison, Wisconsin, United States

Location

Related Publications (1)

  • Fahim RE, Kessler PD, Fuller SA, Kalnik MW. Nicotine vaccines. CNS Neurol Disord Drug Targets. 2011 Dec;10(8):905-15. doi: 10.2174/187152711799219343.

    PMID: 22229310DERIVED

MeSH Terms

Conditions

Smoking CessationSmokingTobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Medical Monitor

    Nabi Biopharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 4, 2009

Study Start

October 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 9, 2012

Record last verified: 2012-05

Locations

US(22)