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Efficacy of NicVAX in Smokers Who Want to Quit Smoking

NCT00318383 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2017-01-12

No results posted yet for this study

Summary

The purpose of this study is to determine whether vaccination with NicVAX will result in a higher continuous abstinence rate than vaccination with placebo in smokers who want to quit smoking. In addition, two different formulations and dosing schedules will be studied, to select the dose and dosing schedule which generates the highest level of anti-nicotine antibodies. The primary study period is 12 months, which was extended by amendment to include up to 2 years of observations.

Conditions

  • Smoking Cessation

Interventions

BIOLOGICAL

NicVAX conjugate vaccine

200 mcg or 400 mcg IM in 4 doses over 6 months; 200 mcg or 400 mcg IM in 5 doses over 6 months; 200 mcg (formulation 2) IM in 5 doses over 6 months; All are adsorbed onto Alhydrogel

BIOLOGICAL

Placebo

Phosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 4 or 5 doses over 6 months

Sponsors & Collaborators

  • Nabi Biopharmaceuticals

    collaborator INDUSTRY

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • Matt Hohenboken, MD, PhD · Nabi Biopharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-09-30
Completion
2007-12-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00318383 on ClinicalTrials.gov