The study, designed to evaluate NicVAX’s safety, antibody response to nicotine, and efficacy, will monitor the effects of 100, 200, 300, and 400mcg injections, over a six-month period.
Previous clinical trials have revealed no significant toxicity up to the 200 mcg dose level, hence the current study is designed to evaluate whether higher doses of NicVAX could further increase anti-nicotine antibody levels without increasing toxicity.
Studies have shown that vaccination with NicVAX can prevent nicotine from reaching the brain and block the effects of nicotine, including effects that can lead to addiction or can reinforce and maintain addiction.
“The vaccine appears to be very well tolerated, even at 200 mcg, the highest dose level tested, allowing us to explore higher and potentially even more efficacious doses,” commented Thomas McLain, chairman, CEO and president of Nabi Biopharmaceuticals.