Antibody and Safety Study of 6 Doses of NicVAX in Smokers

May 8, 2012 updated by: Nabi Biopharmaceuticals

Phase 2 Single Center, Open-label Study to Assess Immunogenicity and Safety of 6 Doses of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®)in Smokers

Prior clinical trials examined several schedules of a nicotine vaccine (NicVAX) for anti-nicotine antibody responses, and their impact on helping smokers quit. The best schedule so far has been one with doses at weeks 0, 4, 8, 16 and 26. This new study tests whether changing the schedule to weeks 0, 4, 8, 12 and 16 is an improvement for stimulating antibodies to nicotine. Routine vaccine safety information is also collected. Amendment 1 adds a 6th dose at week 26, and extends follow-up through week 52.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 2
  • Phase 1

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
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Accelovance, Inc.

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:

  • Healthy smoker, ≥10 cigarettes per day for 6 months, exhaled carbon monoxide ≥10 ppm
  • Written informed consent
  • Negative urine pregnancy test, and willing to use birth control during the study, if applicable

Exclusion Criteria:

  • Prior exposure to nicotine vaccine
  • Clinically significant allergic reactions, especially to components of the vaccine
  • Serious or unstable clinical disease within the past 6 months
  • Use of any smoking cessation therapy within 30 days preceding 1st dose
  • Immunosuppression, due to: steroids or other immunosuppressants in the last 30 days, history of cancer or cancer treatment in the last 60 months, known HIV infection, or congenital or acquired immunodeficiency
  • Use of any vaccine other than influenza vaccine within 30 days prior to each study dose
  • Use of another IND drug or device within 30 days preceding 1st dose
  • Inability to follow the protocol, or illicit drug use in the past 12 months, or psychiatric disorder in the past 3 months

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NicVAX
Biological: 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)
1.0 ml injection IM given every 4 weeks (weeks 0, 4, 8, 12, 16)
Other Names:
  • NicVAX
Experimental: NicVAX Lot 2
2nd cohort receives a different lot of vaccine from the 1st cohort
Biological: 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)
1.0 ml injection IM given every 4 weeks (weeks 0, 4, 8, 12, 16)
Other Names:
  • NicVAX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-nicotine antibody concentration
Time Frame: 12 time points between screening and week 20
12 time points between screening and week 20

Secondary Outcome Measures

Outcome Measure
Time Frame
Vaccine reactogenicity
Time Frame: for 7 days after each dose
for 7 days after each dose
Adverse events
Time Frame: for 30 weeks after 1st dose (4 wk after last dose)
for 30 weeks after 1st dose (4 wk after last dose)

Collaborators and Investigators

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

Sponsor

Nabi Biopharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

January 9, 2008

First Submitted That Met QC Criteria

January 18, 2008

First Posted (Estimate)

January 21, 2008

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

Other Study ID Numbers

  • Nabi-4513

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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