Efficacy of the nicotine vaccine 3'-AmNic-rEPA (NicVAX) co-administered with varenicline and counselling for smoking cessation: a randomized placebo-controlled trial.
BACKGROUND AND AIMS
Nicotine vaccination has been proposed as a possible treatment to aid smoking cessation. First efficacy results of the nicotine vaccine 3'-AmNic-rEPA (NicVAX) showed that only a subgroup of the top 30% antibody responders achieved higher abstinence rates than placebo. The present study examined the efficacy of adding NicVAX versus placebo to varenicline and behavioural support as an aid in smoking cessation and relapse prevention.


DESIGN
Randomized placebo-controlled trial.


SETTING
Two research centres (Maastricht University Medical Centre and Slotervaart Hospital) in the Netherlands.


PARTICIPANTS
A total of 558 smokers were assigned randomly to six injections with NicVAX (n = 278) or placebo (n = 280) both co-administered with open label varenicline and behavioural support.


MEASURES
Outcomes were prolonged carbon monoxide-validated abstinence from weeks 9 to 52 (primary) and weeks 37 to 52 (secondary). We also performed a pre-planned subgroup analysis in the top 30% antibody responders.


FINDINGS
There was no difference in abstinence rates between NicVAX and placebo from weeks 9 to 52 [27.7 versus 30.0%, odds ratio (OR) = 0.89, 95% confidence interval (CI) = 0.62-1.29] or weeks 37 to 52 (33.8 versus 33.2%, OR = 1.03, 95% CI = 0.73-1.46). The top 30% antibody responders, compared to the placebo group, showed a non-significant tendency towards higher abstinence rates from weeks 37 to 52 (42.2 versus 33.2%, OR = 1.47, 95% CI = 0.89-2.42).


CONCLUSION
The nicotine vaccine, NicVAX, does not appear to improve the chances of stopping smoking when given in addition to varenicline and behavioural support.
['Hoogsteder|Philippe H J|PH|', 'Kotz|Daniel|D|', 'van Spiegel|Paul I|PI|', 'Viechtbauer|Wolfgang|W|', 'van Schayck|Onno C P|OC|']
D000293:Adolescent D000328:Adult D000368:Aged D001552:Benzazepines D003376:Counseling D004311:Double-Blind Method D004359:Drug Therapy, Combination D005260:Female D006801:Humans D008297:Male D008875:Middle Aged D009426:Netherlands D018722:Nicotinic Agonists D011810:Quinoxalines D012008:Recurrence D012907:Smoking D016540:Smoking Cessation D016896:Treatment Outcome D014612:Vaccines D000068580:Varenicline D055815:Young Adult
Efficacy nicotine vaccine randomized trial placebo immunogenicity safety