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Safety and Effectiveness of NicVAX in Treating Nicotine Dependent Individuals

N

Nabi Biopharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Tobacco Use Cessation
Smoking Cessation

Treatments

Biological: NicVAX

Study type

Interventional

Funder types

Industry
NIH

Identifiers

NCT00218413
R01-17894-2
NIDA-17894-2
Nabi-4505
DPMC

Details and patient eligibility

About

Nicotine is highly addictive and many individuals are unable to quit smoking even with treatment. The purpose of this study is to determine the effectiveness of various doses of NicVAX in treating nicotine dependent individuals.

Full description

Tobacco use is the single leading preventable cause of death in the United States. Nicotine is an alkaloid that is derived from the tobacco plant responsible for the psychoactive and addictive effects of smoking. Immunotherapy may be useful in preventing and treating nicotine dependent individuals. NicVAX is a nicotine vaccine, a type of immunotherapy that may be effective in smoking cessation and preventing relapse to nicotine. The purpose of this study is to evaluate the safety and efficacy of various dosing levels and dosing frequencies of NicVAX in treating nicotine dependent individuals.

Enrollment

51 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Current smoker
  • Good general health, including mental health
  • Alveolar carbon monoxide level greater than or equal to 10 ppm

Exclusion criteria

  • Prior exposure to NicVAX
  • Known allergy to any of the components of NicVAX
  • Use of any smoking cessation aide
  • Pregnant or breastfeeding

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

51 participants in 5 patient groups

1
Experimental group
Treatment:
Biological: NicVAX
Biological: NicVAX
Biological: NicVAX
Biological: NicVAX
Biological: NicVAX
2
Experimental group
Treatment:
Biological: NicVAX
Biological: NicVAX
Biological: NicVAX
Biological: NicVAX
Biological: NicVAX
3
Experimental group
Treatment:
Biological: NicVAX
Biological: NicVAX
Biological: NicVAX
Biological: NicVAX
Biological: NicVAX
4
Experimental group
Treatment:
Biological: NicVAX
Biological: NicVAX
Biological: NicVAX
Biological: NicVAX
Biological: NicVAX
5
Experimental group
Treatment:
Biological: NicVAX
Biological: NicVAX
Biological: NicVAX
Biological: NicVAX
Biological: NicVAX

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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