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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01304810
First received: February 9, 2011
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Nicotine Dependence
Biological: NicVAX vaccine
Biological: Placebo
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Nabi Biopharmaceuticals:

Primary Outcome Measures:
  • Antibody Levels [ Time Frame: 24 months after the initial injection ] [ Designated as safety issue: No ]
    Analyze blood samples to determine nicotine antibody levels.


Secondary Outcome Measures:
  • Safety as measured by serious adverse events [ Time Frame: 18 months after the initial injection ] [ Designated as safety issue: Yes ]
    Evaluate serious adverse events

  • Safety as measured by serious adverse events [ Time Frame: 24 months after the initial injection ] [ Designated as safety issue: Yes ]
    Evaluate serious adverse events

  • Antibody Levels [ Time Frame: 18 months after the initial injection ] [ Designated as safety issue: No ]
    Analyze blood samples to determine nicotine antibody levels


Biospecimen Retention:   Samples Without DNA

serum samples


Enrollment: 300
Study Start Date: January 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NicVAX
NicVAX vaccine
Biological: NicVAX vaccine
Prior treatment with NicVAX in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.
Placebo vaccine
Placebo vaccine
Biological: Placebo
Prior treatment with Placebo in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304810

Locations
United States, California
NicVAX Investigator
Newport Beach, California, United States
NicVAX Investigator
San Diego, California, United States
United States, Florida
NicVAX Investigator
Miami, Florida, United States
United States, Idaho
NicVAX Investigator
Boise, Idaho, United States
United States, Kentucky
NicVAX Investigator
Lexington, Kentucky, United States
United States, Maryland
NicVAX Investigator
College Park, Maryland, United States
United States, Massachusetts
NicVAX Investigator
Boston, Massachusetts, United States
United States, New York
NicVAX Investigator
Rochester, New York, United States
United States, North Carolina
NicVAX Investigator
Raleigh, North Carolina, United States
United States, Oregon
NicVAX Investigator
Portland, Oregon, United States
United States, Virginia
NicVAX Investigator
Norfolk, Virginia, United States
United States, Washington
NicVAX Investigator
Seattle, Washington, United States
Sponsors and Collaborators
Nabi Biopharmaceuticals
Investigators
Study Director: Medical Director Nabi Biopharmaceuticals
  More Information

No publications provided

Responsible Party: Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01304810     History of Changes
Other Study ID Numbers: Nabi-4522
Study First Received: February 9, 2011
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Nabi Biopharmaceuticals:
NicVAX
Smoking cessation

ClinicalTrials.gov processed this record on September 22, 2014