Antibody and Safety Study of 5 Doses of NicVAX in Smokers - Full Text View

Sponsored by:	Nabi Biopharmaceuticals
Information provided by:	Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00598325

Purpose

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.

Condition	Intervention	Phase
Smoking	Biological: 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)	Phase I Phase II

MedlinePlus related topics: Smoking

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Nabi Biopharmaceuticals:

Primary Outcome Measures:

Anti-nicotine antibody concentration [ Time Frame: 12 time points between screening and week 20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Vaccine reactogenicity [ Time Frame: for 7 days after each dose ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: for 30 weeks after 1st dose (4 wk after last dose) ] [ Designated as safety issue: Yes ]

Enrollment:	74
Study Start Date:	January 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
NicVAX: Experimental	Biological: 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®) 1.0 ml injection IM given every 4 weeks (weeks 0, 4, 8, 12, 16)
NicVAX Lot 2: Experimental 2nd cohort receives a different lot of vaccine from the 1st cohort	Biological: 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®) 1.0 ml injection IM given every 4 weeks (weeks 0, 4, 8, 12, 16)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598325

Locations

United States, Maryland
Accelovance, Inc.
Rockville, Maryland, United States, 20850

Sponsors and Collaborators

Nabi Biopharmaceuticals

Investigators

Study Director:

Matt Hohenboken, MD, PhD

Nabi Biopharmaceuticals

More Information

No publications provided

Responsible Party:	Nabi Biopharmaceuticals ( Matt Hohenboken, MD, PhD, Executive Director, Clinical & Medical Affairs )
Study ID Numbers:	Nabi-4513
Study First Received:	January 9, 2008
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00598325 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Nabi Biopharmaceuticals:

Nicotine
Vaccine
Immunogenicity
Tobacco
Habits

Study placed in the following topic categories:

Nicotine polacrilex
Smoking
Antibodies
Nicotine
Immunoglobulins

ClinicalTrials.gov processed this record on May 07, 2009