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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01304810

Enrollment

300

Registered

2011-02-25

Start date

2011-01-31

Completion date

2011-08-31

Last updated

2012-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine Dependence, Smoking Cessation

Keywords

NicVAX, Smoking cessation

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.

Interventions

BIOLOGICALNicVAX vaccine

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

BIOLOGICALPlacebo

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Antibody Levels	24 months after the initial injection	Analyze blood samples to determine nicotine antibody levels.

Secondary

Measure	Time frame	Description
Safety as measured by serious adverse events	18 months after the initial injection	Evaluate serious adverse events
Antibody Levels	18 months after the initial injection	Analyze blood samples to determine nicotine antibody levels

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026