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OpenTrials
Completed

NCT Number: NCT00598325

Antibody and Safety Study of 6 Doses of NicVAX in Smokers

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.

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Key information

Conditions

Smoking Behavior Habits

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Accelovance, Inc.

Rockville, Maryland, 20850, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Biological

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

Other names: NicVAX

Primary outcomes

  1. Anti-nicotine antibody concentration

    Time frame: 12 time points between screening and week 20

Secondary outcomes

  1. Vaccine reactogenicity

    Time frame: for 7 days after each dose

  2. Adverse events

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

Sponsors and collaborators

Lead sponsor

Nabi Biopharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 21, 2008
Registry last updated
May 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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