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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00218413
Other study ID # NIDA-17894-2
Secondary ID Nabi-4505R01-178
Status Completed
Phase Phase 2
First received September 16, 2005
Last updated January 11, 2017
Start date October 2004
Est. completion date August 2006

Study information

Verified date November 2008
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority Netherlands: Independent Ethics CommitteeUnited States: Federal Government
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date August 2006
Est. primary completion date August 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Biological:
NicVAX
100 µg, Formulation A, on Days 0, 21, 42, 91 & 182
NicVAX
200 µg, Formulation A, on Days 0, 21, 42, 91 & 182
NicVAX
200 µg, Formulation B, on Days 0, 21, 42m 91 & 182
NicVAX
300 µg, Formulation B, on Days 0, 21, 42, 91 & 182
NicVAX
400 µg, Formulation B, on Days 0, 21, 42, 91 & 182

Locations

Country Name City State
Netherlands University of Maastricht Maastricht

Sponsors (2)

Lead Sponsor Collaborator
Nabi Biopharmaceuticals National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anti-nicotine Antibody concentrations 19 time points from Day 0 to 365 No
Secondary Smoking cessation periods of 2 weeks, 4 weeks, or 12 weeks duration No
Secondary Fagerstrom Test for Nicotine Dependence 7 time points from Day 0 to 365 No
Secondary Safety: vaccine reactogenicity 7 days after each dose Yes
Secondary Safety: adverse events Day 0-365 Yes
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