Smoking
Conditions
Keywords
Smoking, NicVAX, Smoking vaccine
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.
Interventions
BIOLOGICALNicVAX Vaccine
NicVAX Vaccine given 6 times over 6 months
Sponsors
Nabi Biopharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity | At Week 14 | To compare imunogenicity of two lots by serum antibody concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | Through Week 16 | Assess safety by adverse events reported |
Countries
United States
Outcome results
None listed