Antibody and Safety Study of 6 Doses of NicVAX in Smokers

Nabi Biopharmaceuticals

Status and phase

Completed

Phase 2

Phase 1

Conditions

Smoking

Treatments

Biological: 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00598325

Nabi-4513

Details and patient eligibility

About

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.

Enrollment

74 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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