Antibody and Safety Study of 6 Doses of NicVAX in Smokers
Phase 1
Completed
- Conditions
- Smoking
- Interventions
- Biological: 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)
- Registration Number
- NCT00598325
- Lead Sponsor
- Nabi Biopharmaceuticals
- Brief Summary
Prior clinical trials examined several schedules of a nicotine vaccine (NicVAX) for anti-nicotine antibody responses, and their impact on helping smokers quit. The best schedule so far has been one with doses at weeks 0, 4, 8, 16 and 26. This new study tests whether changing the schedule to weeks 0, 4, 8, 12 and 16 is an improvement for stimulating antibodies to nicotine. Routine vaccine safety information is also collected. Amendment 1 adds a 6th dose at week 26, and extends follow-up through week 52.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
Inclusion Criteria
- Healthy smoker, ≥10 cigarettes per day for 6 months, exhaled carbon monoxide ≥10 ppm
- Written informed consent
- Negative urine pregnancy test, and willing to use birth control during the study, if applicable
Exclusion Criteria
- Prior exposure to nicotine vaccine
- Clinically significant allergic reactions, especially to components of the vaccine
- Serious or unstable clinical disease within the past 6 months
- Use of any smoking cessation therapy within 30 days preceding 1st dose
- Immunosuppression, due to: steroids or other immunosuppressants in the last 30 days, history of cancer or cancer treatment in the last 60 months, known HIV infection, or congenital or acquired immunodeficiency
- Use of any vaccine other than influenza vaccine within 30 days prior to each study dose
- Use of another IND drug or device within 30 days preceding 1st dose
- Inability to follow the protocol, or illicit drug use in the past 12 months, or psychiatric disorder in the past 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NicVAX 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®) - NicVAX Lot 2 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®) 2nd cohort receives a different lot of vaccine from the 1st cohort
- Primary Outcome Measures
Name Time Method Anti-nicotine antibody concentration 12 time points between screening and week 20
- Secondary Outcome Measures
Name Time Method Vaccine reactogenicity for 7 days after each dose Adverse events for 30 weeks after 1st dose (4 wk after last dose)
Trial Locations
- Locations (1)
Accelovance, Inc.
🇺🇸Rockville, Maryland, United States