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

Smoking Cessation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304810
• Other study ID #: Nabi-4522
• Status: Completed
• Phase: Phase 3
• First received: February 9, 2011
• Last updated: May 10, 2012
• Start date: January 2011
• Est. completion date: August 2011

Study information

• Verified date: May 2012
• Source: Nabi Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Nicotine Dependence
• Smoking Cessation

Intervention

Biological:
• NicVAX vaccine
Prior treatment with NicVAX in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.
• Placebo
Prior treatment with Placebo in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Nabi Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody Levels	Analyze blood samples to determine nicotine antibody levels.	24 months after the initial injection	No
Secondary	Safety as measured by serious adverse events	Evaluate serious adverse events	18 months after the initial injection	Yes
Secondary	Safety as measured by serious adverse events	Evaluate serious adverse events	24 months after the initial injection	Yes
Secondary	Antibody Levels	Analyze blood samples to determine nicotine antibody levels	18 months after the initial injection	No