Overview

This trial is active, not recruiting.

Condition smoking cessation
Treatments nicvax conjugate vaccine, placebo
Phase phase 2
Sponsor National Institute on Drug Abuse (NIDA)
Collaborator Nabi Biopharmaceuticals
Start date May 2006
End date September 2007
Trial size 313 participants
Trial identifier NCT00318383, 1 R01 DA017894-01A1, Nabi - 4512

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
200 mcg NicVAX in each of 4 doses
nicvax conjugate vaccine 3'-aminomethylnicotine-rEPA conjugate vaccine
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
(Experimental)
200 mcg NicVAX in each of 5 doses
nicvax conjugate vaccine 3'-aminomethylnicotine-rEPA conjugate vaccine
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
(Experimental)
400 mcg NicVAX in each of 4 doses
nicvax conjugate vaccine 3'-aminomethylnicotine-rEPA conjugate vaccine
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
(Experimental)
400 mcg NicVAX in each of 5 doses
nicvax conjugate vaccine 3'-aminomethylnicotine-rEPA conjugate vaccine
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
(Placebo Comparator)
Placebo in 4 or 5 doses
placebo
Phosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 4 or 5 doses over 6 months
(Experimental)
200 mcg NicVAX formulation 2 in each of 5 doses
nicvax conjugate vaccine 3'-aminomethylnicotine-rEPA conjugate vaccine
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

Primary Outcomes

Measure
Continuous smoking abstinence
time frame: 8 week interval (Weeks 19 to 26, inclusive, following the first vaccination)

Secondary Outcomes

Measure
Point prevalence abstinence
time frame: at 12 months, and other time points; extended up to 24 months
Duration of smoking abstinence
time frame: at 6 and 12 months
Safety
time frame: 0-12 months, and extended up to 24 months
Numbers of cigarettes per day
time frame: Target quit day to 12 months
Cumulative number of cigarettes smoked
time frame: during weeks 18-26
Exhaled CO
time frame: at clinic visits
Urine cotinine
time frame: at clinic visits
Modified Minnesota Nicotine Withdrawal Questionnaire
time frame: weekly for 6 months, daily for 14 days after quit attempt
Cigarette Evaluation Questionnaire (a.k.a. Nabi Questionnaire)
time frame: weekly for 6 motnhs
Fagerstrom Test for Nicotine Dependence
time frame: baseline, weeks 26 and 52
serum anti-nicotine antibody concentrations by Elisa
time frame: periodic from baseline to month 12, extended to month 24

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

Official title A Phase 2, Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Study to Assess Efficacy of 3'-Aminomethylnicotine-P.Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) in Smokers Who Want to Quit Smoking
Description Cigarette smoking is responsible for over 400,000 (1 out of every 5) deaths in the United States each year. Most smokers are aware of the health consequences and want to quit, but have difficulty doing so. Only 3-5% of smokers who quit on their own are successful. Since the vast majority of those who attempt to quit will fail, the need for better approaches to smoking cessation is clear and urgent. A safe and effective means of blocking the effects of nicotine would be of considerable interest as a potential treatment for tobacco use. Vaccination to produce nicotine-specific antibodies may be viewed as an alternative method of blocking nicotine effects. Nicotine is a small molecule that does not elicit an immune response in animals of humans. In order for the immune system to respond to this hapten, nicotine can be combined or bound to a larger molecule in a unique manner so that an immune response is mounted against nicotine. Nabi Biopharmaceuticals has developed a conjugate vaccine (NicVAX) that consists of 3'-aminomethylnicotine bound to Pseudomonas aeruginosa exoprotein A, an exotoxin that has been made non-toxic by an amino acid deletion. Subjects will be randomized to one of four treatment groups. Within each treatment group, 75 subjects will be randomized in a 2:1 ratio (NicVAX:Placebo), yielding a total of 50 active and 25 placebo subjects for each treatment group. There will be 12 subjects enrolled in a fifth open label arm to evaluate immunogenicity. A quit date will be set at the end of week 7 or at the end of week 5, depending on the dosing schedule. Continuous abstinence will be measured between the end of week 18 and the end of week 26.
Trial information was received from ClinicalTrials.gov and was last updated in November 2008.
Information provided to ClinicalTrials.gov by National Institute on Drug Abuse (NIDA).