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

February 9, 2011
May 10, 2012
January 2011
August 2011   (final data collection date for primary outcome measure)
Antibody Levels [ Time Frame: 24 months after the initial injection ] [ Designated as safety issue: No ]
Analyze blood samples to determine nicotine antibody levels.
Same as current
Complete list of historical versions of study NCT01304810 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Follow-up Study to Assess Long-term Immunogenicity and Safety of NicVAX/Placebo as an Aid to Smoking Cessation
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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

serum samples

Non-Probability Sample

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

  • Smoking Cessation
  • Nicotine Dependence
  • Biological: NicVAX vaccine
    Prior treatment with NicVAX in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.
  • Biological: Placebo
    Prior treatment with Placebo in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.
  • NicVAX
    NicVAX vaccine
    Intervention: Biological: NicVAX vaccine
  • Placebo vaccine
    Placebo vaccine
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01304810
Nabi-4522
No
Nabi Biopharmaceuticals
Nabi Biopharmaceuticals
Not Provided
Study Director: Medical Director Nabi Biopharmaceuticals
Nabi Biopharmaceuticals
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP