Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.

A Double Blind, Placebo-controlled, Multi-centre Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of Repeated s.c Administrations of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00736047

Enrollment

200

Registered

2008-08-15

Start date

2008-08-31

Completion date

2009-10-31

Last updated

2017-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smokers

Keywords

Smokers, smoking cessation, vaccine, antibodies, anti-nicotine

Brief summary

This study is designed to determine the efficacy of high nicotine-specific antibody titers in smoking cessation.

Interventions

BIOLOGICALNIC002

BIOLOGICALPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Healthy male and female smoking subjects age 18 to 65 years of age * Subjects must be smoking 10 or more cigarettes per day during the past 12 months * The exhaled breath carbon monoxide (CO) concentration must be 10 ppm or more at screening. Urine cotinine at screening must be positive. * The Fagerström Test for Nicotine Dependence (FTND) score of 5 or above at screening.

Exclusion criteria

* Attempted to quit smoking in the three (3) months. * Prior use of smoking cessation aid. Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Smoking status	12 weeks
Exhaled carbon monoxide	12 weeks

Secondary

Measure	Time frame
Smoking status at various time intervals from target quit date to the end of the study	52 weeks
Safety and tolerability	52 weeks
Immunogenicity (specific anti-nicotine antibodies in serum)	52 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026