Baxter International Inc. today announced Phase I/II data evaluating the safety and immunogenicity of its investigational Lyme disease candidate vaccine during the National Foundation for Infectious Diseases 16th Annual Conference on Vaccine Research in Baltimore, Md.
In this Phase I/II study, the candidate vaccine was shown to induce substantial antibody titers against all targeted species of Borrelia, the causative agent of Lyme disease, the most prevalent tick-transmitted disease, which is reported in the United States and throughout much of the European Union.
Baxter’s Lyme disease vaccine was developed with a novel, multivalent chimeric antigen that targets specific immune functions and is designed to protect against the major species of Borrelia, the bacteria known to cause Lyme disease in Europe and the United States.
“Our candidate Lyme disease vaccine is a great example of innovation in exploring new ways to prevent disease through our vaccine technology,” said Noel Barrett, Ph.D., vice president of research and development in Baxter’s vaccines business. “Based on the results of this study, we are fully committed to further investigating the candidate vaccine in larger populations.”
The phase I/II study evaluated the safety and immunogenicity of the vaccine at a range of antigen doses and formulations (either 30µg, 60µg or 90µg antigen), formulated with or without an adjuvant, an additive to stimulate immune response to the vaccine, in 300 healthy adults. Study participants received three primary immunizations and one booster immunization. The vaccine demonstrated predominantly mild adverse reactions and no vaccine-related serious adverse events. Substantial antibody titers were induced against all species of Borrelia targeted by the vaccine.