A Comparability Study of the Phase 3 Lot and a Single Commercial Lot of NicVAX in Healthy Adult Smokers
Phase 3
Completed
- Conditions
- Smoking
- Registration Number
- NCT01375933
- Lead Sponsor
- Nabi Biopharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Immunogenicity At Week 14 To compare imunogenicity of two lots by serum antibody concentration
- Secondary Outcome Measures
Name Time Method Safety Through Week 16 Assess safety by adverse events reported
Trial Locations
- Locations (1)
NicVAX Investigator
🇺🇸Rockville, Maryland, United States
NicVAX Investigator🇺🇸Rockville, Maryland, United States