Today, Lyme disease vaccines currently exist for dogs, but none have been approved for humans in nearly 15 years — and in that time the disease has grown into a world-wide epidemic. Many remember the disastrous release of the first Lyme vaccine, LYMErix, released back in 1998. The manufacturer — SmithKline Beecham (now GlaxoSmithKline) — claimed it was nearly 80% effective. and completely safe, but was forced to stop selling it in 2002 due to public outcry and Lyme-like symptoms many experienced (the maker claims it was due to a lawsuit backed by anti-vaccine supporters). Eventually GlaxoSmithKline settled out of court.
Over the intervening years, there have been many programs in labs around the world, but this is the first to be approved for trials in humans.
One of the problems is that we still don’t have an adequate way to diagnose Lyme disease with 100% accuracy. Most vaccines work by training the immune system to mount a response that effectively destroys the disease using our own immune machinations. But Lyme disease is a stealth pathogen that seems primarily designed to evade the immune system.
Rightfully, people are worried about relying on a vaccine before the diagnosis/treatment controversy is wholly resolved.
Scientists have shown that the bacteria that causes Lyme effects different mammals in different ways and so it is understandable why there might be an effective vaccine for dogs. Rhesus monkeys are perhaps the closest mammal to humans and veterinarian researchers have made great gains in understanding the pathogen in test projects using them. See European research here , UK research here, and US research here – all using Rhesus monkeys to better understand Lyme disease.
Following the withdrawal of LYMErix from the market, Erol Fikrig, one of the physicians who helped develop the vaccine, tried a different approach.
He focused on the tick’s saliva and found a way to block transmission of the B. burgdorferi bacterium and potentially other bacteria, too. In 2009, Fikrig and his research team published the findings of their studies on mice in Cell Host & Microbe.
Previously in 2013, researchers from Stony Brook University, Brookhaven National Laboratory, NY, and Baxter International Inc., IL, published the results of their trials into another vaccine based on OspA. Stony Brook’s Dr. Benjamin Luft, a pioneer and world-wide Lyme disease expert and researcher has another perspective. He says that one of the main challenges of developing a Lyme disease vaccine is to discover a method that could produce a vaccine effective on all Borrelia species.See my previous post and
Dr. Luft is well-known for first mapping the Borrelia genome which is one of the most complex of bacteria. His team has developed a research base (BorreliaBase) for genome maps which has grown to include 15 unique strains of Borrelia burgdorferi, with 27 total. However this number only includes mapped strains – it is estimated that there are over 100 infectious strains in the US and over 200 world-wide but there is no way to effectively document every strain as the bacteria morphs in each individual.
With the aid of technologies and expertise at Stony Brook and Brookhaven, Drs. Luft and Dunn focused vaccine development on the most abundant Borrelia (of the lab species) outer surface protein found when the spirochete bacteria reside in ticks, which commonly transmit the disease.
Using the structure of this protein, called OspA, they created a set of unique OspA proteins not found in nature. These new OspA proteins, called chimeras, share different parts from different species of Borrelia.
“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 new European clinical trial is based on these chimeras 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.
Collectively, the article co-authors included researchers from Baxter Bioscience; Health Center Mainz in Germany; the Medical University of Vienna in Austria; the Institute of Tropical Medicine, University of Tubingen in Germany, and Stony Brook Medicine in the U.S.