Efficacy and Safety of Nicotine-Qbeta Vaccine in Smokers

Phase 2 Completed 341 enrolled Cytos Biotechnology AG

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to help smokers quitting by vaccinating them with CYT002-NicQb. Upon vaccination, the smoker will generate antibodies directed against free nicotine. The antibodies will bind nicotine and prevent its passage into the brain. The successfully vaccinated smoker will have no reward effect after smoking, thus braking the vicious circle of nicotine addiction.

Timeline

Start: 2003-12
Primary completion: 2005-03
Completion: 2005-10

Outcome

Missed primary endpoint

paper Whereas Nicotine-Qbeta did not significantly increase continuous abstinence rates in the intention-to-treat population PMID 18575629 ↗

Publications

Cornuz J, Zwahlen S, Jungi WF, Osterwalder J, Klingler K, van Melle G, Bangala Y, Guessous I, Muller P, Willers J, Maurer P, Bachmann MF, Cerny T. A vaccine against nicotine for smoking cessation: a randomized controlled trial. PLoS One. 2008 Jun 25;3(6):e2547. doi: 10.1371/journal.pone.0002547.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CYT002-NicQb	Vaccine	—	Intramuscular

Indications

No indication recorded.