Antibody and Safety Study of 6 Doses of NicVAX in Smokers

NCT ID: NCT00598325

Last Updated: 2012-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-10-31

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.

Conditions

Smoking

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

NicVAX

Group Type: EXPERIMENTAL

3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)

Intervention Type: BIOLOGICAL

1.0 ml injection IM given every 4 weeks (weeks 0, 4, 8, 12, 16)

NicVAX Lot 2

2nd cohort receives a different lot of vaccine from the 1st cohort

Group Type: EXPERIMENTAL

3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)

Intervention Type: BIOLOGICAL

1.0 ml injection IM given every 4 weeks (weeks 0, 4, 8, 12, 16)

Interventions

3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)

1.0 ml injection IM given every 4 weeks (weeks 0, 4, 8, 12, 16)

Intervention Type: BIOLOGICAL

Other Intervention Names

NicVAX

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nabi Biopharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matt Hohenboken, MD, PhD

Role: STUDY_DIRECTOR

Nabi Biopharmaceuticals

Locations

Accelovance, Inc.

Rockville, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22229310 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21270788 (View on PubMed)

Other Identifiers

Nabi-4513

Identifier Type: -

Identifier Source: org_study_id