Clinical trial NCT00598325: Antibody and Safety Study of 6 Doses of NicVAX in Smokers
Official title: Phase 2 Single Center, Open-label Study to Assess Immunogenicity and Safety of 6 Doses of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®)in Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Smoking
Keywords: Nicotine
Vaccine
Immunogenicity
Tobacco
Habits
Lead sponsor: Nabi Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-01-21
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prior clinical trials examined several schedules of a nicotine vaccine (NicVAX) for anti-nicotine antibody responses, and their impact on helping smokers quit. The best schedule so far has been one with doses at weeks 0, 4, 8, 16 and 26. This new study tests whether changing the schedule to weeks 0, 4, 8, 12 and 16 is an improvement for stimulating antibodies to nicotine. Routine vaccine safety information is also collected. Amendment 1 adds a 6th dose at week 26, and extends follow-up through week 52.


Eligibility criteria: Inclusion Criteria:

* Healthy smoker, ≥10 cigarettes per day for 6 months, exhaled carbon monoxide ≥10 ppm
* Written informed consent
* Negative urine pregnancy test, and willing to use birth control during the study, if applicable

Exclusion Criteria:

* Prior exposure to nicotine vaccine
* Clinically significant allergic reactions, especially to components of the vaccine
* Serious or unstable clinical disease within the past 6 months
* Use of any smoking cessation therapy within 30 days preceding 1st dose
* Immunosuppression, due to: steroids or other immunosuppressants in the last 30 days, history of cancer or cancer treatment in the last 60 months, known HIV infection, or congenital or acquired immunodeficiency
* Use of any vaccine other than influenza vaccine within 30 days prior to each study dose
* Use of another IND drug or device within 30 days preceding 1st dose
* Inability to follow the protocol, or illicit drug use in the past 12 months, or psychiatric disorder in the past 3 months

Primary outcomes:
measure: Anti-nicotine antibody concentration
timeFrame: 12 time points between screening and week 20
Secondary outcomes:
measure: Vaccine reactogenicity
timeFrame: for 7 days after each dose
measure: Adverse events
timeFrame: for 30 weeks after 1st dose (4 wk after last dose)
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Accelovance, Inc.
state: Maryland
Study officials:
affiliation: Nabi Biopharmaceuticals
name: Matt Hohenboken, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Fahim RE, Kessler PD, Fuller SA, Kalnik MW. Nicotine vaccines. CNS Neurol Disord Drug Targets. 2011 Dec;10(8):905-15. doi: 10.2174/187152711799219343.
citation: Hatsukami DK, Jorenby DE, Gonzales D, Rigotti NA, Glover ED, Oncken CA, Tashkin DP, Reus VI, Akhavain RC, Fahim RE, Kessler PD, Niknian M, Kalnik MW, Rennard SI. Immunogenicity and smoking-cessation outcomes for a novel nicotine immunotherapeutic. Clin Pharmacol Ther. 2011 Mar;89(3):392-9. doi: 10.1038/clpt.2010.317. Epub 2011 Jan 26.