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Completed

NCT Number: NCT01304810

A Follow-up Study to Assess Long-term Immunogenicity and Safety of NicVAX/Placebo 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.

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Key information

Conditions

Smoking Cessation Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Nicotine Dependence Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NicVAX Investigator, Newport Beach, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NicVAX Vaccine

Biological

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

Placebo

Biological

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

Primary outcomes

  1. Antibody Levels

    Time frame: 24 months after the initial injection

    Analyze blood samples to determine nicotine antibody levels.

Secondary outcomes

  1. Safety as measured by serious adverse events

    Time frame: 18 months after the initial injection

    Evaluate serious adverse events

  2. Safety as measured by serious adverse events

    Time frame: 24 months after the initial injection

    Evaluate serious adverse events

  3. Antibody Levels

    Time frame: 18 months after the initial injection

    Analyze blood samples to determine nicotine antibody levels

Sponsors and collaborators

Lead sponsor

Nabi Biopharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 25, 2011
Registry last updated
May 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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