Safety and Effectiveness of NicVAX in Treating Nicotine Dependent Individuals

January 11, 2017 updated by: Nabi Biopharmaceuticals

A Phase 2 Study to Assess Safety and Immunogenicity of Five Doses of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) Administered to Smokers

Nicotine is highly addictive and many individuals are unable to quit smoking even with treatment. The purpose of this study is to determine the effectiveness of various doses of NicVAX in treating nicotine dependent individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tobacco use is the single leading preventable cause of death in the United States. Nicotine is an alkaloid that is derived from the tobacco plant responsible for the psychoactive and addictive effects of smoking. Immunotherapy may be useful in preventing and treating nicotine dependent individuals. NicVAX is a nicotine vaccine, a type of immunotherapy that may be effective in smoking cessation and preventing relapse to nicotine. The purpose of this study is to evaluate the safety and efficacy of various dosing levels and dosing frequencies of NicVAX in treating nicotine dependent individuals.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

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

  • Netherlands
      • Maastricht, Netherlands, 6229 HA
        • University of Maastricht

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current smoker
  • Good general health, including mental health
  • Alveolar carbon monoxide level greater than or equal to 10 ppm

Exclusion Criteria:

  • Prior exposure to NicVAX
  • Known allergy to any of the components of NicVAX
  • Use of any smoking cessation aide
  • Pregnant or breastfeeding

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Biological: NicVAX
100 μg, Formulation A, on Days 0, 21, 42, 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Biological: NicVAX
200 μg, Formulation A, on Days 0, 21, 42, 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Biological: NicVAX
200 μg, Formulation B, on Days 0, 21, 42m 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Biological: NicVAX
300 μg, Formulation B, on Days 0, 21, 42, 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Biological: NicVAX
400 μg, Formulation B, on Days 0, 21, 42, 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Experimental: 2
Biological: NicVAX
100 μg, Formulation A, on Days 0, 21, 42, 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Biological: NicVAX
200 μg, Formulation A, on Days 0, 21, 42, 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Biological: NicVAX
200 μg, Formulation B, on Days 0, 21, 42m 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Biological: NicVAX
300 μg, Formulation B, on Days 0, 21, 42, 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Biological: NicVAX
400 μg, Formulation B, on Days 0, 21, 42, 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Experimental: 3
Biological: NicVAX
100 μg, Formulation A, on Days 0, 21, 42, 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Biological: NicVAX
200 μg, Formulation A, on Days 0, 21, 42, 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Biological: NicVAX
200 μg, Formulation B, on Days 0, 21, 42m 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Biological: NicVAX
300 μg, Formulation B, on Days 0, 21, 42, 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Biological: NicVAX
400 μg, Formulation B, on Days 0, 21, 42, 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Experimental: 4
Biological: NicVAX
100 μg, Formulation A, on Days 0, 21, 42, 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Biological: NicVAX
200 μg, Formulation A, on Days 0, 21, 42, 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Biological: NicVAX
200 μg, Formulation B, on Days 0, 21, 42m 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Biological: NicVAX
300 μg, Formulation B, on Days 0, 21, 42, 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Biological: NicVAX
400 μg, Formulation B, on Days 0, 21, 42, 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Experimental: 5
Biological: NicVAX
100 μg, Formulation A, on Days 0, 21, 42, 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Biological: NicVAX
200 μg, Formulation A, on Days 0, 21, 42, 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Biological: NicVAX
200 μg, Formulation B, on Days 0, 21, 42m 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Biological: NicVAX
300 μg, Formulation B, on Days 0, 21, 42, 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine
Biological: NicVAX
400 μg, Formulation B, on Days 0, 21, 42, 91 & 182
Other Names:
  • 3'-aminomethylnicotine-rEPA conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-nicotine Antibody concentrations
Time Frame: 19 time points from Day 0 to 365
19 time points from Day 0 to 365

Secondary Outcome Measures

Outcome Measure
Time Frame
Smoking cessation
Time Frame: periods of 2 weeks, 4 weeks, or 12 weeks duration
periods of 2 weeks, 4 weeks, or 12 weeks duration
Fagerstrom Test for Nicotine Dependence
Time Frame: 7 time points from Day 0 to 365
7 time points from Day 0 to 365
Safety: vaccine reactogenicity
Time Frame: 7 days after each dose
7 days after each dose
Safety: adverse events
Time Frame: Day 0-365
Day 0-365

Collaborators and Investigators

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

Sponsor

Nabi Biopharmaceuticals

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Gary Horwith, Nabi Biopharmaceuticals
  • Principal Investigator: Arjen De Vos, MD, PhD, 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

October 1, 2004

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-17894-2
  • DPMC (Other Identifier: NIDA)
  • Nabi-4505
  • R01-17894-2

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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