Nabi Biopharmaceuticals announced the preliminary results of a phase I safety and immunogenicity trial of NicVAX (Nicotine Conjugate Vaccine), an investigational nicotine conjugate vaccine, in 20 healthy volunteers. Although the study blind remains in effect, analysis of blood samples from the participants receiving NicVAX shows that a single dose of NicVAX resulted in a rapid immune response and generated substantial amounts of nicotine specific antibodies. Local reactions to vaccination were mild to moderate, temporary and required no therapeutic intervention. Antibody levels were detected within 7 days of vaccination and were maintained or continued to increase through 60 days post-vaccination.
"While this trial remains ongoing in order to maximize the safety data collected, we are pleased to note the ability of NicVAX to rapidly stimulate the formation of sustained levels of nicotine-specific antibodies in vaccinated individuals," stated David J. Gury, chairman, president, and chief executive officer of Nabi Biopharmaceuticals.
The ongoing NicVAX trial is a double-blinded, placebo-controlled, phase I, single center, safety and immunogenicity trial in 20 healthy, non-smoker adults that were randomly assigned to receive either an intramuscular injection of 200 µg of NicVAX or placebo. Investigators are collecting blood samples throughout the trial to assess safety parameters and to measure antibody levels to both nicotine and carrier protein. In addition, an Independent Safety Committee has reviewed unblinded local and systemic reactions and adverse events at various times during the trial.
"The encouraging clinical trial results announced today, together with positive results from previously described animal studies of NicVAX, suggest that additional investigation of this vaccine as an aid to smoking cessation and possibly to prevent nicotine addiction in individuals beginning to use tobacco is warranted. Based on these preliminary findings, we plan to initiate additional clinical trials of NicVAX in smokers and ex-smokers later this year," said Gury.
NicVAX is a nicotine conjugate vaccine, conjugated to a carrier protein, recombinant exoprotein A (rEPA). This is the same carrier protein that Nabi Biopharmaceuticals has used in its investigational product StaphVAX (Staphylococcus aureus Polysaccharide Conjugate Vaccine). StaphVAX was previously shown to be safe and well tolerated in clinical trials in over 1500 subjects. Development of NicVAX is funded, in part, by grant DA-13327 from the U.S. National Institute on Drug Abuse.