Clinical trial NCT01304810: A Follow-up Study to Assess Long-term Immunogenicity and Safety of NicVAX/Placebo as an Aid to Smoking Cessation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking Cessation
Nicotine Dependence
Keywords: NicVAX
Smoking cessation
Lead sponsor: Nabi Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-02-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be invited into this study following their participation in Nabi-4514 or Nabi-4515.

Brief 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.

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 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.

Primary outcomes:
measure: Antibody Levels
timeFrame: 24 months after the initial injection
Secondary outcomes:
measure: Safety as measured by serious adverse events
timeFrame: 18 months after the initial injection
measure: Safety as measured by serious adverse events
timeFrame: 24 months after the initial injection
measure: Antibody Levels
timeFrame: 18 months after the initial injection
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: NicVAX Investigator
state: California
city: San Diego
country: United States
facility: NicVAX Investigator
state: California
city: Miami
country: United States
facility: NicVAX Investigator
state: Florida
city: Boise
country: United States
facility: NicVAX Investigator
state: Idaho
city: Lexington
country: United States
facility: NicVAX Investigator
state: Kentucky
city: College Park
country: United States
facility: NicVAX Investigator
state: Maryland
city: Boston
country: United States
facility: NicVAX Investigator
state: Massachusetts
city: Rochester
country: United States
facility: NicVAX Investigator
state: New York
city: Raleigh
country: United States
facility: NicVAX Investigator
state: North Carolina
city: Portland
country: United States
facility: NicVAX Investigator
state: Oregon
city: Norfolk
country: United States
facility: NicVAX Investigator
state: Virginia
city: Seattle
country: United States
facility: NicVAX Investigator
state: Washington
Study officials:
affiliation: Nabi Biopharmaceuticals
name: Medical Director
role: STUDY_DIRECTOR
References: