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Completed Phase 2 Interventional

Efficacy of NicVAX in Smokers Who Want to Quit Smoking

ClinicalTrials.gov ID: NCT00318383

Public ClinicalTrials.gov record NCT00318383. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 7:04 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2, Multi-center, Randomized, Double-blinded, Placebo-controlled Study to Assess Efficacy of 3'-Aminomethylnicotine-P.Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) in Smokers Who Want to Quit Smoking

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00318383
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
313 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2006
Primary completion
Aug 31, 2007
Completion
Nov 30, 2007
Last update posted
Jan 11, 2017

2006 – 2007

United States locations

U.S. sites
9
U.S. states
8
U.S. cities
9
Facility City State ZIP Site status
David Geffen School of Medicine at UCLA Los Angeles California 90095
University of California San Francisco California 94143
University of Connecticut Health Center Farmington Connecticut 06030
Department of Public & Community Health College Park Maryland 20742
Tobacco Research Center, Massachusetts General Hospital Boston Massachusetts 02114
University of Minnesota Minneapolis Minnesota 55414
University of Nebraska Medical Center Omaha Nebraska 68198
Oregon Health & Science University Portland Oregon 97239
University of Wisconsin Madison Wisconsin 53711

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00318383, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 11, 2017 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00318383 live on ClinicalTrials.gov.

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