Efficacy and Safety of NicVAX® Co-administered With Varenicline (Champix®)

Maastricht University Medical Centre (MUMC)

Status and phase: Completed; Phase 2

Conditions: Smoking Lapse Behavior; Smoking Behavior; Smoking Relapse Behavior

Treatments: Biological: NicVAX vaccine; Drug: Varenicline; Biological: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00995033

MEC 08-5-066

ZonMw 40-00812-98-07-004

Nabi-4508

ZonMw 61200014

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.

Enrollment: 558 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Smokes at least 10 cigarettes per day
• Good general health
• Negative pregnancy test prior to study entry

Exclusion criteria

• Prior exposure to NicVAX or any other nicotine vaccine
• Known allergic reaction to alum or any of the components of the vaccine
• Use of systemic steroids, immunosuppressive agents or other medication that might interfere with an immune response
• Cancer or cancer treatment in the last 5 years
• HIV infection
• History of drug or alcohol abuse or dependence within 12 months
• Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease
• Previous intolerance to varenicline
• Inability to fulfill all visits for approximately 54 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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558 participants in 2 patient groups, including a placebo group

NicVAX conjugate vaccine

Experimental group

Treatment:

Biological: NicVAX vaccine

Drug: Varenicline

Placebo

Placebo Comparator group

Description:

Biological

Treatment:

Biological: Placebo

Drug: Varenicline