Study of TA-NIC to Assess the Efficacy and Safety of the Vaccine as an Aid to Smoking Cessation

Sponsor

Celtic Pharma Development Services (Industry)

Overall Status

Completed

CT.gov ID

NCT00633321

Collaborator

(none)

522

Enrollment

Locations

Arms

21.1

Duration (Months)

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Over 1 billion people worldwide smoke, resulting in an estimated 4 million deaths annually from smoking-related disease.1 Persistent and long-term smoking leads to an increased risk of cardiovascular damage, respiratory disease, and a higher incidence of a variety of cancers; but for smokers who can quit there is an immediate and significant beneficial impact on their health and life expectancy. Cigarette smoking remains the leading preventable cause of death in the United States (US), accounting for approximately 1 of every 5 deaths (438,000 people) each year.

This Phase 2 study will investigate the efficacy and tolerability of 2 doses of TA-NIC compared to placebo as an aid to smoking cessation in smokers who are motivated to quit.

Condition or Disease	Intervention/Treatment	Phase
Smoking	Biological: TA-NIC Biological: Placebo	Phase 2

Detailed Description

This is a multicenter, double-blind, randomized, placebocontrolled, 3-arm, Phase 2 study evaluating the efficacy and safety of TA-NIC as an aid for smoking cessation in smokers motivated to quit within 12 weeks. At the start of the study, each subject will set a Target Quit Date, which must be within 12 weeks after first injection. Each subject will receive 7 injections (vaccinations) from Weeks 0 to 16. Subjects will be encouraged to follow a phased reduction in cigarette consumption leading up to the Target Quit Date. All vaccinated subjects will be offered a counseling session at each clinic visit and will be contacted by telephone at Weeks 1, 3, 5, 7, 9, 14, 18, and 21 to provide up to 10 minutes of support and counseling for their smoking cessation. Smoking cessation will be measured during a 4-week assessment period from Week 22 to Week 26. Smoking cessation will be defined as complete abstinence during this 4-week period. Subject follow-up will continue to Week 52.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

522 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose-Ranging Study of 100 or 250 μg of TA-NIC to Assess the Efficacy and Safety of the Vaccine as an Aid to Smoking Cessation

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 TA-NIC 100 μg	Biological: TA-NIC TA-NIC vaccine will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.
Experimental: 2 TA-NIC 250 μg	Biological: TA-NIC TA-NIC vaccine will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.
Placebo Comparator: 3	Biological: Placebo Placebo will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.

Arm

Intervention/Treatment

Experimental: 1

TA-NIC 100 μg

Biological: TA-NIC

TA-NIC vaccine will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.

Experimental: 2

TA-NIC 250 μg

Biological: TA-NIC

TA-NIC vaccine will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.

Placebo Comparator: 3

Biological: Placebo

Placebo will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.

Outcome Measures

Primary Outcome Measures

4-week assessment period quit rate at Week 26 measured by self-reported abstinence in the 4 weeks immediately prior to the 26 week visit and supported by CO breath test data [Week 26]

Secondary Outcome Measures

Measures of anti-nicotine antibody levels at key study visits [Prospective]
Quit status at the final follow-up visit (Week 52) [Week 52]
CO breath test measurements at key study visits [Prospective]
Serum cotinine levels at key study visits [Prospective]
Nicotine dependence as measured by Fagerström score, for those subjects who are still smokers [Prospective]
Urge to smoke (craving) and smoking satisfaction, as measured by QSU-brief and mCEQ, respectively [Prospective]
Continuous abstinence between Weeks 26 and 52 [Prospective]
Safety and tolerability of TA-NIC [Prospective]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Aged ≥18 years
Female subjects must be either of non child bearing potential (i.e., either surgically sterilized or post menopausal) or must be using adequate contraception, have a negative pregnancy test and must agree to continue to use such precautions for 3 months after the last immunization. Acceptable contraceptive methods are oral or parenteral hormonal contraceptives; intrauterine device; barrier and spermicide. Abstinence or partner vasectomy are not acceptable methods.
A "smoker" who has smoked on a regular basis for a least a year and is currently smoking at least 10 cigarettes per day
Is motivated to quit smoking in the next 12 weeks
Agrees to avoid smoking cessation pharmacotherapies, and any other methods of smoking cessation, other than those provided as part of this protocol
Has good general health as determined by medical history, general clinical examination, vital signs (systolic blood pressure ≤140 mm Hg, diastolic blood pressure ≤90 mm Hg, heart rate ≤100 beats per minute, and body temperature of 36.1°-37.8° C), and clinical laboratory test results; and has a World Health Organization (WHO) performance status of 0 or 1 (see Appendix A for WHO performance status scale)
Has provided written informed consent.

Exclusion Criteria:

Have known immunodeficiency, or tested positive for human immunodeficiency virus (HIV) or hepatitis B at screening.
Are taking medication known to have significant immunosuppressive effects such as systemic glucocorticoids (topical and inhaled formulations are permitted)
Are intending to use other forms of smoking cessation pharmacotherapies or other methods of smoking cessation during the period of the study, other than those provided as part of this protocol; or who are receiving smoking cessation products (e.g., bupropion, clonidine, nortriptyline) for indications other than smoking cessation during the period of study
History of sensitivity to aluminum hydroxide gel
History of severe adverse reaction to cholera vaccine
Known current user of drugs of abuse, or with a recent history (within the past 6 months) of use of drugs of abuse
Recent (within the past 6 months) history of alcohol abuse
Current non-cigarette tobacco use
Previous vaccination with TA-NIC
Participation in another clinical study within 30 days before study entry
Female subjects with a positive pregnancy test; lactating mothers; women of child-bearing potential who do not agree to continue adequate contraception (i.e., oral or parenteral hormonal contraceptives, intrauterine device, barrier, and/or spermicide) and pregnancy tests from start of study through 3 months after the last immunization; or women who are planning to become pregnant during the period of the study
Clinical laboratory value outside the normal range of the central laboratory (see Appendix G), unless the value has been justified by the Investigator in writing
Any other factor that in the opinion of the Investigator would make the subject unsuitable for the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Benchmark Research	Sacramento	California	United States	95816
2	Benchmark Research	Metairie	Louisiana	United States	70006
3	Columbia Medical Practice	Columbia	Maryland	United States	21045
4	Centennial Medical Group	Elkridge	Maryland	United States	21075
5	Mayo Clinic	Rochester	Minnesota	United States	55905
6	CNS Research Institute, P.C.	Clementon	New Jersey	United States	08021
7	CRI Worldwide, LLC Kirkbride Center	Philadelphia	Pennsylvania	United States	19139
8	Benchmark Research	Austin	Texas	United States	78705
9	Benchmark Research - Fort Worth	Fort Worth	Texas	United States	76135