Antibody and Safety Study of 6 Doses of NicVAX in Smokers

NCT00598325 | Completed Phase 1

• 1 other identifier: Nabi-4513
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Keywords

Nicotine; Vaccine; Immunogenicity; Tobacco; Habits

Outcome Measures

Primary Outcomes (1)

• Anti-nicotine antibody concentration

  12 time points between screening and week 20

Secondary Outcomes (2)

• Vaccine reactogenicity

  for 7 days after each dose

• Adverse events

  for 30 weeks after 1st dose (4 wk after last dose)

Study Arms (2)

NicVAX

EXPERIMENTAL

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

NicVAX Lot 2

EXPERIMENTAL

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

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

Interventions

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

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

Also known as: NicVAX

NicVAX; NicVAX Lot 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nabi Biopharmaceuticals: lead

Study Sites (1)

Accelovance, Inc.

Rockville, Maryland, 20850, United States

Location

Related Publications (2)

• 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.

  PMID: 22229310 DERIVED

• 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.

  PMID: 21270788 DERIVED

MeSH Terms

Conditions

Smoking; Habits

Interventions

NicVAX

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Matt Hohenboken, MD, PhD

  Nabi Biopharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 21, 2008
• Study Start: January 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 9, 2012

Record last verified: 2012-05

Locations

US (1)