A randomised, placebo-controlled, multi-centre study on the efficacy of Niccine, a vaccine for nicotine, in smoking relapse prevention, assessed in abstinent, adult smokers.

• Conditions: The intended indication for the drug under investigation is smoking relapse prevention. Tobacco smoking has been identified as the single largest preventable cause of morbidity and premature death in the developed world. The prevalence of smoking range from about 20 to 50 per cent in the developed countries and from a global perspective, tobacco smoking continues to increase. The study will be performed in smokers.; MedDRA version: 9.1Level: LLTClassification code 10056478Term: Nicotine addiction

• Registration Number: EUCTR2007-003250-29-SE
• Lead Sponsor: Independent Pharmaceutica AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1.Cigarette smokers, smoking on average at least 10 cigarettes per day, has fewer than three months of abstinence in the past year and is motivated to quit.
2.Men or women, 25 to 50 years of age (inclusive).
3.Women of childbearing capacity must use a reliable contraceptive method, e.g. the double barrier method, an intra-uterine device or oral contraceptive.
4.Positive for exhaled carbon monoxide (CO), >5 ppm.
5.Healthy and with normal findings in the pre-study physical examination (as judged by the Investigator)
6.Has signed the Informed Consent Form

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnant and lactating female
2.Previous treatment with any nicotine vaccine
3.Vaccination with any other vaccine product from four weeks before first dose or planned vaccination until four weeks after the last vaccination with the investgational product.
4.Vaccination with any other medicinal product containing TT within two years prior to enrolment.
5.Concurrent use of any drug that may have a negative effect on the immune system (as judged by the investigator)
6.Use of antidepressant or antipsychotic drugs within six months prior to enrolment in the study
7.Concurrent use of any other nicotine containing product than cigarettes
8.Current diagnosis or a history of repeated depressive episodes or of anxiety disorders or psychosis.
9.Clinical diagnosis of moderate to severe asthma or COPD or emphysema.
10.Unstable heart disease (as judged by the Investigator).
11.Use of any smoking cessation drugs within six months of enrolment in the study.
12.Known hyper reactivity to previous vaccinations with TT.
13.Known or suspected allergy or hypersensitivity to any of the components in the investigational or reference products.
14.Suspected abuse or misuse of alcohol or any of the drugs tested for during screening.
15.Diseases with immunological etiology, e.g. autoimmune disorders.
16.History of cancer.
17.Positive serology for HIV and/or Hepatitis B and/or Hepatitis C.
18.Participation in another clinical study within three months prior to enrolment or during the present study.
19.If the Investigator, for any other reason, assesses that the Subject should not be included (e.g. planned travel, expected low compliance, expected withdrawal).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified