Antibody and Safety Study of 6 Doses of NicVAX in Smokers

Smoking Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598325
• Other study ID #: Nabi-4513
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 9, 2008
• Last updated: May 8, 2012
• Start date: January 2008
• Est. completion date: October 2010

Study information

• Verified date: May 2012
• Source: Nabi Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smoking

Intervention

Biological:
• 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)
1.0 ml injection IM given every 4 weeks (weeks 0, 4, 8, 12, 16)

Locations

Country	Name	City	State
United States	Accelovance, Inc.	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Nabi Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-nicotine antibody concentration		12 time points between screening and week 20	No
Secondary	Vaccine reactogenicity		for 7 days after each dose	Yes
Secondary	Adverse events		for 30 weeks after 1st dose (4 wk after last dose)	Yes