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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01375933
• Other study ID #: Nabi-4516
• Status: Completed
• Phase: Phase 3
• First received: June 15, 2011
• Last updated: May 10, 2012
• Start date: May 2011
• Est. completion date: October 2011

Study information

• Verified date: May 2012
• Source: Nabi Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

Biological:
• NicVAX Vaccine
NicVAX Vaccine given 6 times over 6 months

Locations

Country	Name	City	State
United States	NicVAX Investigator	Huntsville	Alabama
United States	NicVAX Investigator	Melbourne	Florida
United States	NicVAX Investigator	Peoria	Illinois
United States	NicVAX Investigator	Rockville	Maryland
United States	NicVAX Investigator	San Diego	California
United States	NicVAX Investigator	South Bend	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Nabi Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity	To compare imunogenicity of two lots by serum antibody concentration	At Week 14	No
Secondary	Safety	Assess safety by adverse events reported	Through Week 16	Yes