In the article, "Safety and immunogenicity of a novel multivariant OspA vaccine against Lyme borreliosis in healthy adults: a double-blind, randomized, dose-escalation phase 1/2 trial," Principal Investigator P. Noel Barrett, of Baxter, Biomedical Research Centre, and co-authors evaluated the safety and immunogenicity of the vaccine in a range of doses in 300 people living in Austria and Germany. Study participants received three primary immunizations and one booster immunization. All doses and formulations, some of which included an adjuvant, an additive to stimulate immune response to the vaccine, induced substantial antibody titers against all species of Borrelia. The vaccine demonstrated predominantly mild adverse reactions and no-vaccine related serious events occurred in the sample population.
"The results of the clinical trial conducted by Baxter are promising because the vaccine generated a potent human immune reaction, covered the complete range of Borrelia active in the entire Northern hemisphere, and produced no major side effects," said Luft, a co-author on the paper. "We hope that a larger-scale, Phase 3 trial will demonstrate not only a strong immune response but true efficacy in a large population that illustrates protection against Lyme disease."
Dr. Luft said that for years, one of the main challenges of developing a Lyme disease vaccine was to discover a method that could produce a vaccine effective on all Borrelia species. With the aid of technologies and expertise at Stony Brook and Brookhaven, Luft and Dunn focused vaccine development on the most abundant Borrelia outer surface protein found when the spirochete bacteria reside in ticks, which commonly transmit the disease. Using the scaffold of this protein, called OspA, they, in collaboration with researchers at Baxter, bioengineered a set of unique OspA proteins not found in nature. These new OspAs share different parts from different species of Borrelia. The new proteins are called chimeras.
"After a series of experimentations and refinements, formulations consisting of these new OspA proteins were shown to protect against a broad spectrum of Lyme disease spirochetes," said Luft, summarizing the research results.
The vaccine used in the European clinical trial is based on these newly created OspA proteins and is therefore designed for broad based coverage.
For more details on the purpose and scope of the clinical trial, see the National Institutes of Health Clinical Trials website page Phase 1/2 Lyme Vaccine Study.
http://www.dddmag.com/news/2013/05/...3/05/lyme-disease-vaccine-shows-promise-trial
"The results of the clinical trial conducted by Baxter are promising because the vaccine generated a potent human immune reaction, covered the complete range of Borrelia active in the entire Northern hemisphere, and produced no major side effects," said Luft, a co-author on the paper. "We hope that a larger-scale, Phase 3 trial will demonstrate not only a strong immune response but true efficacy in a large population that illustrates protection against Lyme disease."
Dr. Luft said that for years, one of the main challenges of developing a Lyme disease vaccine was to discover a method that could produce a vaccine effective on all Borrelia species. With the aid of technologies and expertise at Stony Brook and Brookhaven, Luft and Dunn focused vaccine development on the most abundant Borrelia outer surface protein found when the spirochete bacteria reside in ticks, which commonly transmit the disease. Using the scaffold of this protein, called OspA, they, in collaboration with researchers at Baxter, bioengineered a set of unique OspA proteins not found in nature. These new OspAs share different parts from different species of Borrelia. The new proteins are called chimeras.
"After a series of experimentations and refinements, formulations consisting of these new OspA proteins were shown to protect against a broad spectrum of Lyme disease spirochetes," said Luft, summarizing the research results.
The vaccine used in the European clinical trial is based on these newly created OspA proteins and is therefore designed for broad based coverage.
For more details on the purpose and scope of the clinical trial, see the National Institutes of Health Clinical Trials website page Phase 1/2 Lyme Vaccine Study.
http://www.dddmag.com/news/2013/05/...3/05/lyme-disease-vaccine-shows-promise-trial