Abstract
Tobacco smoking is the cause of 20% of Canadian deaths per year. Nicotine vaccines present a promising alternative to traditional smoking cessation products, but to date, no vaccine has been able to move through all phases of clinical trials. We have previously demonstrated that the AFPL1-conjugate nicotine vaccine does not induce systemic or immunotoxicity in a mouse model and that a heterologous vaccination approach is more advantageous than the homologous routes to inducing mucosal and systemic anti-nicotine antibodies. The purpose of this study was to confirm the safety profile of the vaccine in a repeat-dose toxicity study. The heterologous vaccination strategy was again used, and Sprague Dawley rats were administered a dose five times greater than in our previous studies. Physiological conditions, food and water consumption, body temperature, injection site inflammation, relative weights of organs, histopathology, and blood chemistry and hematology were evaluated during the course of the vaccination period to determine the safety of the vaccine. The AFPL1-conjugate nicotine vaccine did not induce clinically relevant changes or induce symptoms that would be associated with toxicity, making it a promising candidate for future investigations.
Highlights
Tobacco smoking continues to be both a social and economic burden in Canada, resulting in approximately one out of every five deaths and 16.2 billion dollars in both direct and indirect costs per year [1]
The antibodies were able to bind to nicotine in the lung and in the blood when the mice were challenged in vivo with nicotine, as demonstrated by competitive ELISAs for IgA and IgG [5]
The World Health Organization estimates that up to half of all lifetime smokers of tobacco will die as a result of smoking; developing a novel and effective anti-nicotine vaccine is crucial
Summary
Tobacco smoking continues to be both a social and economic burden in Canada, resulting in approximately one out of every five deaths and 16.2 billion dollars in both direct and indirect costs per year [1]. A nicotine vaccine has been pursued as an alternative. The antibodies were able to bind to nicotine in the lung and in the blood when the mice were challenged in vivo with nicotine, as demonstrated by competitive ELISAs for IgA and IgG [5]. Both the homologous and heterologous routes did not show signs of toxicity when assessing daily physiological conditions and the gross necropsy of the organs [5]
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