A Follow-up Study to Assess Long-term Immunogenicity and Safety of NicVAX/Placebo as an Aid to Smoking Cessation

A Phase 3, Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Follow-up Study to Assess Long-term Immunogenicity and Safety of NicVAX™ as an Aid to Smoking Cessation

The purpose of the study is to obtain two year follow up data for subjects that received six vaccinations of NicVAX in prior phase III studies. No treatment will be administered. Anti-nicotine antibody levels and safety data will be collected.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Nicotine Dependence
• Intervention / Treatment: Biological: NicVAX vaccine; Biological: Placebo

Detailed Description

This study will follow subjects that participated in the NicVAX phase III studies for a second year. These predecessor studies, Nabi-4514 (NCT#00836199) and Nabi-4515 (NCT#01102114) evaluate the efficacy and safety of 6 vaccinations of NicVAX or placebo as an aid to smoking cessation. The two phase III studies are one year in duration, and subjects who complete these studies are eligible to enroll in Nabi-4522. As the phase III studies are ongoing, subject assignment to NicVAX or placebo will remain masked. No intervention will be administered in Nabi-4522. Subjects will be followed for immunogenicity (anti-nicotine antibody level)and for safety.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States
      • NicVAX Investigator
    • San Diego, California, United States
      • NicVAX Investigator
  • Florida
    • Miami, Florida, United States
      • NicVAX Investigator
  • Idaho
    • Boise, Idaho, United States
      • NicVAX Investigator
  • Kentucky
    • Lexington, Kentucky, United States
      • NicVAX Investigator
  • Maryland
    • College Park, Maryland, United States
      • NicVAX Investigator
  • Massachusetts
    • Boston, Massachusetts, United States
      • NicVAX Investigator
  • New York
    • Rochester, New York, United States
      • NicVAX Investigator
  • North Carolina
    • Raleigh, North Carolina, United States
      • NicVAX Investigator
  • Oregon
    • Portland, Oregon, United States
      • NicVAX Investigator
  • Virginia
    • Norfolk, Virginia, United States
      • NicVAX Investigator
  • Washington
    • Seattle, Washington, United States
      • NicVAX Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be invited into this study following their participation in Nabi-4514 or Nabi-4515.

Description

Inclusion Criteria:

• Subjects who agree and sign consent to participate in this follow-up study.
• Subjects randomized and completed month 12 of the Nabi-4514 or Nabi-4515 study.
• Subjects who have received a total of 6 injections in Nabi-4514 or Nabi-4515.

Exclusion Criteria:

• Anticipated inability to follow the study protocol through-out the study period.
• Known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder compliance or failure to sign informed consent.
• Subjects who intend to receive, or who are receiving an Investigational New Drug/Device during the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NicVAX; NicVAX vaccine	Biological: NicVAX vaccine; Prior treatment with NicVAX in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.
Placebo vaccine	Biological: Placebo; Prior treatment with Placebo in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody Levels	Analyze blood samples to determine nicotine antibody levels.	24 months after the initial injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as measured by serious adverse events	Evaluate serious adverse events	18 months after the initial injection
Safety as measured by serious adverse events	Evaluate serious adverse events	24 months after the initial injection
Antibody Levels	Analyze blood samples to determine nicotine antibody levels	18 months after the initial injection

Collaborators and Investigators

• Sponsor: Nabi Biopharmaceuticals
• Investigators: Study Director: Medical Director, Nabi Biopharmaceuticals

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: February 9, 2011
• First Submitted That Met QC Criteria: February 24, 2011
• First Posted (Estimate): February 25, 2011

Study Record Updates

• Last Update Posted (Estimate): May 14, 2012
• Last Update Submitted That Met QC Criteria: May 10, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Smoking cessation; NicVAX
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: Nabi-4522