A Second Study of NicVAX/Placebo as an Aid for Smoking Cessation

Nabi Biopharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Smoking Cessation

Treatments: Biological: NicVAX Vaccine; Biological: Placebo Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01102114

Nabi-4515

Details and patient eligibility

About

The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.

Enrollment: 1,000 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current smoker who smokes at least 10 cigarettes a day during the past year and wants to quit smoking.
• Smokers who are in good general health.

Exclusion criteria

• Prior exposure to NicVAX or any other nicotine vaccine.
• Use of systemic steroids.
• 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.
• Inability to fulfill all visits for approximately 52 weeks.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,000 participants in 2 patient groups, including a placebo group

Placebo Vaccine

Placebo Comparator group

Treatment:

Biological: Placebo Vaccine

NicVAX Vaccine

Experimental group

Treatment:

Biological: NicVAX Vaccine