SmokersPhase 2NCT00369616

Efficacy and Safety of Nicotine-Qbeta Vaccine in Smokers

A Phase 2 study testing CYT002-NicQb in people with Smokers, run by Cytos Biotechnology AG at 3 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Smokers
What is being tested?: CYT002-NicQb
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 341 participants
Where: 3 sitesSwitzerland
Study dates: Dec 2003to Oct 2005
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Adult, Older adult

Who may be able to join

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

Who cannot join

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:

Show all 27Show fewer

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
Significant renal disease
Significant hematological disorder
Significant pulmonary disease
History of malignancy
Autoimmune disease
Organic neurological disorder or significant psychiatric disorder
Use of psychoactive drug within one month before enrolment
Abuse of drugs or alcohol
Subjects using any concomitant medications due to chronic illness which bears a high risk of fluctuation in disease activity or exacerbations during a 12-months period such as coronary heart disease, asthma, severe COPD, chronic rheumatoid disease, diabetes, etc. should be excluded.
Obesity: BMI > 35 kg/m2
Use of concomitant nicotine replacement treatment (NRT) at screening or visit 1
Any planned surgical intervention during the study period

Trial locations and contacts

3 sites in 1 country.

Switzerland3 sites

University Hospital Lausanne (CHUV)
Lausanne, Canton of Vaud, 1011
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007
Lungenzentrum Hirslandenklinik Zuerich
Zurich, Canton of Zurich, 8029

Other trials in Switzerland

About this study

Official title: Evaluation of Efficacy and Safety of Nicotine-Qbeta (NicQb) Vaccine Versus Placebo in Healthy Smokers

Conditions: Smokers
Being tested: CYT002-NicQb

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CYT002-NicQbBiological

Study groups in NCT00369616
Study group	Role	What they receive
NicQb vaccine	Experimental	Not described Receives: Biological: CYT002-NicQb
Placebo vaccine	Placebo comparator	Not described Receives: Biological: CYT002-NicQb

What is being measured

The primary outcome is the main question the study is designed to answer.

Abstinence from smoking defined as self-reported abstinence and confirmed by measurement of carbon monoxide in exhaled air less than 10ppm
Measured: 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
Measured: 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)
Measured: 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
Measured: Baseline, monthly up to month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2003Oct 2005

First posted29 Aug 2006 (estimated)
Study startDec 2003
Primary completionMar 2005
Study completionOct 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SmokersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 341 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00369616
Sponsor's protocol ID: CYT002-NicQb 02
Status last verified: Mar 2008
First submitted: 25 Aug 2006
Last updated: 15 Nov 2010
Results posted: No

Publications

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.
PubMed 18575629

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
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Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants
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All Smokers trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Efficacy and Safety of Nicotine-Qbeta (NicQb) Vaccine Versus Placebo in Healthy Smokers
ClinicalTrials.gov ID: NCT00369616
Acronym / sponsor ID: CYT002-NicQb 02
Conditions: Smokers
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 341 participants (actual)
Lead sponsor: Cytos Biotechnology AGIndustry (pharma, biotech, devices)
Study start: Dec 2003
Primary completion: Mar 2005 (actual)
Study completion: Oct 2005 (actual)
First posted: 29 Aug 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
NicQb vaccine	Experimental	Biological: CYT002-NicQb
Placebo vaccine	Placebo comparator	Biological: CYT002-NicQb

Who may qualify

Ages: 18 to 70 years
Sex: All
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (27 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CYT002-NicQb	Biological	NicQb vaccine, Placebo vaccine

Primary outcome

Abstinence from smoking defined as self-reported abstinence and confirmed by measurement of carbon monoxide in exhaled air less than 10ppm
Time frame: 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
Time frame: 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)
Time frame: Baseline, and at various times up to month 12

1 secondary outcome

Craving and withdrawal symptoms by Questionnaire on Smoking Urges and Wisconsin Withdrawal Scale
Time frame: Baseline, monthly up to month 6

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2010.
Derived from this study: PubMed 18575629Cornuz 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.

Related trials for Smokers

Not yet recruiting
Home-Based Respiratory Muscle Training and Aerobic Exercise Programs to Improve Lung Health in Current and Former Cigarette Smokers
Lung Carcinoma
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
Active, not recruiting
Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants
Smoking
Active, not recruitingObservational study
EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jacques Cornuz, Prof. study chair

Department of Medicine; University Hospital Lausanne, Switzeland

Thomas Cerny, Prof. principal investigator

Department of Medicine, Kantonsspital St. Gallen, Switzerland

Felix Jungi, MD principal investigator

Department of Medicine, Kantonsspital St. Gallen, Switzerland

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CYT002-NicQb in people with Smokers, run by Cytos Biotechnology AG at 3 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Abstinence from smoking defined as self-reported abstinence and confirmed by measurement of carbon monoxide in exhaled air less than 10ppm (time frame: Monthly up to month 6, and during follow-up at months 9 and 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00369616, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2010.