The 131st Annual Meeting (November 15-19, 2003) of APHA

Abstract #55887

Arjen De Vos, MD, PhD¹, Gary Horwith, MD¹, Ali Fattom, PhD¹, Robert Naso, PhD¹, Steven Fuller, PhD¹, Larry R. Muenz, PhD², Ann Kennedy, MD³, and Sofiane Ennifar, PhD¹. (1) Nabi Biopharmaceuticals, 12276 Wilkins Avenue, Rockville, MD 20852, 301-255-6921, adevos@nabi.com, (2) L Muenz & Associates, 14613 Drum Hill Court, Rockville, MD 20878, (3) Novum Pharmacuetical Research Services, 5900 Penn Avenue, Pittsburgh, PA 15206

Introduction: Nicotine is a small molecule that does not elicit an immune response. Nabi Biopharmaceuticals has developed NicVAX, a conjugate vaccine consisting of 3’-aminomethylnicotine bound to recombinant P. aeruginosa exoprotein A, a non-toxic carrier protein. This vaccine produces nicotine specific antibodies that reversibly binds free plasma nicotine, and therefore may block passage of nicotine to the CNS, and the effects of nicotine. Method: Twenty healthy adults were randomized 1:1 to receive a total single dose of 200 µg NicVAX or alum placebo in a phase 1, double-blinded, placebo-controlled, single center, safety and immunogenicity trial. Vaccine reactogenicity, adverse events, and anti-nicotine antibody levels were collected for 175 days following vaccination. Results: Antibody was measurable as early as Day 14 and concentrations increased or were sustained through Day 119. Day 175 antibody levels were 60 % of peak. Nineteen of 20 subjects reported at least one local reactogenicity event. The majority of these events were mild or moderate in intensity. Twelve of 20 subjects reported at least one systemic reactogenicity event and the majority were mild. As in the case of the local events, all were self-limited and resolved within a few days. Adverse events were mild or moderate in severity. Unblinded safety and immunogenicity data will be presented. Summary: A single dose of 200 µg of NicVAX is safe, well tolerated, and immunogenic. These results support further investigation of this novel approach to treat nicotine dependence.

Learning Objectives:

At the conclusion of the session, the participant will have
• an insight in the early development of a novel approach to treat nicotine dependence. 2)ability to assess the safety and immunogenicity of a conjugated nicotine vaccine.

Keywords: Smoking Cessation, Clinical Trails

Related Web page: www.nabi.com

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: Nabi Biopharmaceuticals
I have a significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.
Relationship: employment