Lyme Disease Vaccine
Shows Promise in Clinical Trial
From
ScienceDaily.com
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| Telltale rash associated with Lyme Disease |
Editor's note: Lyme disease is all too common in Charlestown given our high tick population.
The
results of a phase 1/2 clinical trial in Europe of an investigational Lyme
disease vaccine co-developed by researchers at Stony Brook University,
Brookhaven National Laboratory, and at Baxter International Inc., a U.S. based
healthcare company, revealed it to be promising and well tolerated, according
to a research paper published online in The Lancet Infectious Diseases.
The
vaccine was shown to produce substantial antibodies against all targeted
species of Borrelia, the causative agent of Lyme disease in Europe and the
United States. Baxter International conducted the clinical trial of the
vaccine.
Since
the early 1990s, Benjamin Luft, MD, the Edmund D. Pellegrino Professor of
Medicine at Stony Brook University School of Medicine, and the late John Dunn,
Ph.D., a biologist at Brookhaven National Laboratory, spearheaded the initial
development of the original vaccine antigen concept, and together with
researchers at Baxter International helped bioengineer the formulation used in
the clinical trial.
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,
PhD, 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 Dr. 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, Drs. 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 Dr. 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.
Story Source:
The
above story is reprinted from materials provided by Stony Brook
Medicine, via Newswise.
Note: Materials may be edited for content and length. For further
information, please contact the source cited above.
Journal Reference:
1. Nina Wressnigg, Eva-Maria Pöllabauer, Gerald
Aichinger, Daniel Portsmouth, Alexandra Löw-Baselli, Sandor Fritsch, Ian Livey,
Brian A Crowe, Michael Schwendinger, Peter Brühl, Andreas Pilz, Thomas Dvorak,
Julia Singer, Clair Firth, Benjamin Luft, Bernhard Schmitt, Markus Zeitlinger,
Markus Müller, Herwig Kollaritsch, Maria Paulke-Korinek, Meral Esen, Peter G
Kremsner, Hartmut J Ehrlich, P Noel Barrett. Safety and immunogenicity
of a novel multivalent OspA vaccine against Lyme borreliosis in healthy adults:
a double-blind, randomised, dose-escalation phase 1/2 trial. The
Lancet Infectious Diseases, 2013; DOI: 10.1016/S1473-3099(13)70110-5
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Stony Brook Medicine (2013, May 10). Lyme disease vaccine shows
promise in clinical trial.ScienceDaily. Retrieved May 10, 2013, from
http://www.sciencedaily.com/releases/2013/05/130510075337.htm
