NCT00318383

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
313

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2006

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2006

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 12, 2017

Status Verified

November 1, 2008

Enrollment Period

1.3 years

First QC Date

April 24, 2006

Last Update Submit

January 11, 2017

Conditions

Smoking Cessation

Keywords

VaccineImmunogenicityRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Continuous smoking abstinence

    8 week interval (Weeks 19 to 26, inclusive, following the first vaccination)

Secondary Outcomes (11)

  • Point prevalence abstinence

    at 12 months, and other time points; extended up to 24 months

  • Duration of smoking abstinence

    at 6 and 12 months

  • Safety

    0-12 months, and extended up to 24 months

  • Numbers of cigarettes per day

    Target quit day to 12 months

  • Cumulative number of cigarettes smoked

    during weeks 18-26

  • +6 more secondary outcomes

Study Arms (6)

1

EXPERIMENTAL

200 mcg NicVAX in each of 4 doses

Biological: NicVAX conjugate vaccine

2

EXPERIMENTAL

200 mcg NicVAX in each of 5 doses

Biological: NicVAX conjugate vaccine

3

EXPERIMENTAL

400 mcg NicVAX in each of 4 doses

Biological: NicVAX conjugate vaccine

4

EXPERIMENTAL

400 mcg NicVAX in each of 5 doses

Biological: NicVAX conjugate vaccine

5

PLACEBO COMPARATOR

Placebo in 4 or 5 doses

Biological: Placebo

6

EXPERIMENTAL

200 mcg NicVAX formulation 2 in each of 5 doses

Biological: NicVAX conjugate vaccine

Interventions

NicVAX conjugate vaccineBIOLOGICAL

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

Also known as: 3'-aminomethylnicotine-rEPA conjugate vaccine
12346
PlaceboBIOLOGICAL

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

5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smokes at least 15 cigarettes per day
  • Wants to quit smoking
  • Good general health
  • Negative pregnancy test prior to study entry
  • Carbon monoxide level greater than 10 ppm

You may not qualify if:

  • Prior exposure to NicVAX or any other nicotine vaccine
  • Known allergic reaction to alum or any of the components of the vaccine
  • Use of steroids, immunosuppressive agents or other medication that might interfere with an immune response

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

Location

University of California

San Francisco, California, 94143, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Department of Public & Community Health

College Park, Maryland, 20742, United States

Location

Tobacco Research Center, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Wisconsin

Madison, Wisconsin, 53711, United States

Location

Related Publications (2)

  • Fahim RE, Kessler PD, Fuller SA, Kalnik MW. Nicotine vaccines. CNS Neurol Disord Drug Targets. 2011 Dec;10(8):905-15. doi: 10.2174/187152711799219343.

    PMID: 22229310DERIVED

  • Hatsukami DK, Jorenby DE, Gonzales D, Rigotti NA, Glover ED, Oncken CA, Tashkin DP, Reus VI, Akhavain RC, Fahim RE, Kessler PD, Niknian M, Kalnik MW, Rennard SI. Immunogenicity and smoking-cessation outcomes for a novel nicotine immunotherapeutic. Clin Pharmacol Ther. 2011 Mar;89(3):392-9. doi: 10.1038/clpt.2010.317. Epub 2011 Jan 26.

    PMID: 21270788DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Matt Hohenboken, MD, PhD

    Nabi Biopharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 24, 2006

First Posted

April 26, 2006

Study Start

May 1, 2006

Primary Completion

September 1, 2007

Study Completion

December 1, 2007

Last Updated

January 12, 2017

Record last verified: 2008-11

Locations

US(9)