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

A Phase 3, Multicenter, Double-Blinded, Randomized, Study to Assess Comparability of a Single Phase 3 Lot and a Single Commercial Lot of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) in Healthy Adult Smokers

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Biological: NicVAX Vaccine

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35802
      • NicVAX Investigator
  • California
    • San Diego, California, United States, 92018
      • NicVAX Investigator
  • Florida
    • Melbourne, Florida, United States, 32935
      • NicVAX Investigator
  • Illinois
    • Peoria, Illinois, United States, 61602
      • NicVAX Investigator
  • Indiana
    • South Bend, Indiana, United States, 46601
      • NicVAX Investigator
  • Maryland
    • Rockville, Maryland, United States, 20850
      • NicVAX Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: NicVAX - Phase 3 Lot	Biological: NicVAX Vaccine; NicVAX Vaccine given 6 times over 6 months
ACTIVE_COMPARATOR: NicVAX - Commercial Lot	Biological: NicVAX Vaccine; NicVAX Vaccine given 6 times over 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity	To compare imunogenicity of two lots by serum antibody concentration	At Week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Assess safety by adverse events reported	Through Week 16

Collaborators and Investigators

• Sponsor: Nabi Biopharmaceuticals

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: June 15, 2011
• First Submitted That Met QC Criteria: June 17, 2011
• First Posted (ESTIMATE): June 20, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 14, 2012
• Last Update Submitted That Met QC Criteria: May 10, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Smoking; NicVAX; Smoking vaccine
• Other Study ID Numbers: Nabi-4516