NCT00369616

Brief Summary

The purpose of this study is to help smokers quitting by vaccinating them with CYT002-NicQb. Upon vaccination, the smoker will generate antibodies directed against free nicotine. The antibodies will bind nicotine and prevent its passage into the brain. The successfully vaccinated smoker will have no reward effect after smoking, thus braking the vicious circle of nicotine addiction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
341

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2003

Geographic Reach
1 country

3 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

Study Start

First participant enrolled

December 1, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2006

Completed
Last Updated

November 15, 2010

Status Verified

March 1, 2008

Enrollment Period

1.2 years

First QC Date

August 25, 2006

Last Update Submit

November 11, 2010

Conditions

Smokers

Outcome Measures

Primary Outcomes (3)

  • Abstinence from smoking defined as self-reported abstinence and confirmed by measurement of carbon monoxide in exhaled air less than 10ppm

    Monthly up to month 6, and during follow-up at months 9 and 12

  • Immunogenicity of the vaccine, by measuring specific anti-nicotine IgG antibodies by ELISA

    Baseline, monthly up to month 6, and months 9 and 12

  • Safety and tolerability by recording adverse events, injection site examinations, vital signs, standard clinical laboratory (serum chemistry, hematology)

    Baseline, and at various times up to month 12

Secondary Outcomes (1)

  • Craving and withdrawal symptoms by Questionnaire on Smoking Urges and Wisconsin Withdrawal Scale

    Baseline, monthly up to month 6

Study Arms (2)

NicQb vaccine

EXPERIMENTAL
Biological: CYT002-NicQb

Placebo vaccine

PLACEBO COMPARATOR
Biological: CYT002-NicQb

Interventions

CYT002-NicQbBIOLOGICAL
NicQb vaccinePlacebo vaccine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Age 18 to 70 years
  • Smokers: \> 10 and ≤ 40 cigarettes per day and smoking history of more than 3 years
  • Fageström Test for Nicotine Dependence (FTND) score ≥ 5
  • Female participant must meet one of the following criteria: a) no reproductive potential due to menopause, hysterectomy, bilateral oophorectomy, or tubal ligation; b) agrees to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 12 additional months after the last immunization

You may not qualify if:

  • Pregnant or nursing
  • History of severe allergy or immunological disorders
  • Blood donation within previous 30 days
  • Surgery within previous 30 days
  • Use of investigational drugs within previous 60 days
  • Significant cardiovascular disease:
  • angina pectoris
  • congestive heart failure
  • clinically significant murmurs
  • previous angioplasty or coronary artery bypass surgery
  • Active infectious disease:
  • WBC \> 12 000 cells/µL
  • Seropositivity for Hepatitis B and C
  • History of risk behavior to acquire HIV
  • Significant hepatic disease
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

University Hospital Lausanne (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Lungenzentrum Hirslandenklinik Zuerich

Zurich, Canton of Zurich, 8029, Switzerland

Location

Related Publications (1)

  • Cornuz J, Zwahlen S, Jungi WF, Osterwalder J, Klingler K, van Melle G, Bangala Y, Guessous I, Muller P, Willers J, Maurer P, Bachmann MF, Cerny T. A vaccine against nicotine for smoking cessation: a randomized controlled trial. PLoS One. 2008 Jun 25;3(6):e2547. doi: 10.1371/journal.pone.0002547.

    PMID: 18575629DERIVED

MeSH Terms

Interventions

nicotine Qbeta vaccine

Study Officials

  • Jacques Cornuz, Prof.

    Department of Medicine; University Hospital Lausanne, Switzeland

    STUDY CHAIR

  • Thomas Cerny, Prof.

    Department of Medicine, Kantonsspital St. Gallen, Switzerland

    PRINCIPAL INVESTIGATOR

  • Felix Jungi, MD

    Department of Medicine, Kantonsspital St. Gallen, Switzerland

    PRINCIPAL INVESTIGATOR

  • Karl Klingler, MD

    Lung Center Hirslanden, Zuerich, Switzerland

    PRINCIPAL INVESTIGATOR

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
INDUSTRY

Study Record Dates

First Submitted

August 25, 2006

First Posted

August 29, 2006

Study Start

December 1, 2003

Primary Completion

March 1, 2005

Study Completion

October 1, 2005

Last Updated

November 15, 2010

Record last verified: 2008-03

Locations

CH(3)