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

May 8, 2012 updated by: Nabi Biopharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo Vaccine
Biological: Placebo Vaccine
Placebo vaccine given 6 times over 6 months
EXPERIMENTAL: NicVAX Vaccine
Biological: NicVAX Vaccine
NicVAX vaccine given 6 times over 6 months

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nabi Biopharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

March 17, 2010

First Submitted That Met QC Criteria

April 9, 2010

First Posted (ESTIMATE)

April 12, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 9, 2012

Last Update Submitted That Met QC Criteria

May 8, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nabi-4515

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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