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

Completed

• Conditions: Smoking Cessation; Nicotine Dependence
• Interventions: Biological: Placebo; Biological: NicVAX vaccine

• Registration Number: NCT01304810
• Lead Sponsor: Nabi Biopharmaceuticals

Brief Summary

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.

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-09
• Study First Submitted QC: 2011-02-24
• Study First Posted: 2011-02-25
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-10
• Last Update Posted: 2012-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo vaccine	Placebo	Placebo vaccine
NicVAX	NicVAX vaccine	NicVAX vaccine

Primary Outcome Measures

Name	Time	Method
Antibody Levels	24 months after the initial injection	Analyze blood samples to determine nicotine antibody levels.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NicVAX Investigator; 🇺🇸 Seattle, Washington, United States