A Comparability Study of the Phase 3 Lot and a Single Commercial Lot of NicVAX in Healthy Adult Smokers

Nabi Biopharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Smoking

Treatments: Biological: NicVAX Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01375933

Nabi-4516

Details and patient eligibility

About

The purpose of this study is to assess the comparability of the phase 3 lot and a single commercial lot of NicVAX in healthy smokers.

Enrollment: 260 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female smokers, age 18-55, who are currently smoking at least 10 cigarettes per day.

Exclusion criteria

• Prior exposure to NicVAX or any other nicotine vaccine.
• History of clinically significant allergic reactions.
• Use of systemic steroids.
• Cancer or cancer treatment within 5 years.
• HIV infection.
• History of drug or alcohol abuse or dependence.
• Required treatment for depression within the past 12 months.
• Body mass index ≥ 30 [calculated as weight (kg)/height2 (m)].
• Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease.
• Inability to fulfill all visits for approximately 30 weeks.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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260 participants in 2 patient groups

NicVAX - Phase 3 Lot

Active Comparator group

Description:

NicVAX - Phase 3 Lot

Treatment:

Biological: NicVAX Vaccine

NicVAX - Commercial Lot

Active Comparator group

Description:

NicVAX - Commercial Lot

Treatment:

Biological: NicVAX Vaccine