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

Nabi Biopharmaceuticals300 enrolled

Overview

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.

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

300

Conditions

Smoking Cessation Nicotine Dependence

Interventions

NicVAX vaccineBIOLOGICAL

Prior treatment with NicVAX in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.

PlaceboBIOLOGICAL

Prior treatment with Placebo in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (12)

NicVAX Investigator

Newport Beach, California, United States

NicVAX Investigator

San Diego, California, United States

NicVAX Investigator

Miami, Florida, United States

Outcomes

Primary Outcomes

Antibody Levels

Analyze blood samples to determine nicotine antibody levels.

Time frame: 24 months after the initial injection

Secondary Outcomes

Safety as measured by serious adverse events

Evaluate serious adverse events

Time frame: 18 months after the initial injection

Safety as measured by serious adverse events

Evaluate serious adverse events

Time frame: 24 months after the initial injection

Antibody Levels

Analyze blood samples to determine nicotine antibody levels

Time frame: 18 months after the initial injection

Data from ClinicalTrials.gov

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