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Author Topic: Lyme Disease Vaccine Shows Promise in Cllinical Trial
RDaywillcome
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Lyme Disease Vaccine Shows Promise in Clinical Trial
Released: 5/9/2013 3:00 PM EDT
Embargo expired: 5/9/2013 6:30 PM EDT
Source Newsroom: Stony Brook Medicine
more news from this source

Reported in The Lancet, results on 300 tested revealed strong immune response to the vaccine

Newswise -- STONY BROOK, N.Y., May 9, 2013 - 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.

Through the Stony Brook University School of Medicine and Brookhaven National Laboratory, The Research Foundation of the State of New York licensed intellectual property of the Lyme vaccine technology to Baxter International.

Baxter International researchers in collaboration with Luft and Dunn developed further innovations employed in the Lyme vaccine 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.

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.
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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.
Citations

The Lancet Infectious Diseases
Benjamin Luft, MD, Edmund D. Pellegrino Professor of Medicine, Stony Brook University School of Medicine

Benjamin Luft, MD, Edmund D. Pellegrino Professor of Medicine, Stony Brook University School of Medicine
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[ 05-11-2013, 06:05 PM: Message edited by: Robin123 ]

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Lymetoo
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I'm sorry but this scares the &*%$# out of me! I feel for the suckers who are getting the vaccine. I'm sure they have no clue of the dangers it could pose.

Even if we have a vaccine that works, it will not protect us from ALL OF THE COINFECTIONS!!

[shake]

--------------------
--Lymetutu--
Opinions, not medical advice!

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Hoops123
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As a victim of lymerix, I would steer wayyyyyyy clear of this
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beaches
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Yep, ditto LT.

But Luft is one of the good guys, so his research is worth following.

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Tincup
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Nightmare, Part II.

--------------------
www.TreatTheBite.com
www.DrJonesKids.org
www.MarylandLyme.org
www.LymeDoc.org

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Keebler
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-
And THIS is why the IDSA is so against treatment and they are likely behind jacking up the price of certain antibiotics.

To anyone new: avoid any kind of lyme vaccine at all costs. This is a very complex topic with disaster fueling it. MANY become very ill and disabled from the previous attempt at a vaccine. But they totally deny there were even any problems at all.

A lyme vaccine also cannot cover all the other tick-borne infections.
-

[ 05-12-2013, 02:20 PM: Message edited by: Keebler ]

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seibertneurolyme
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Does anyone know -- I can't remember who manufactured the previous vaccine -- is this the same company?

Bea Seibert

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randibear
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Prevent???? But what if you already have it???

--------------------
do not look back when the only course is forward

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Lymetoo
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Bea .. I'm pretty sure it was Glaxo/Smith/Kline for the first one.

Randi.. then it for SURE would be a bad idea!

--------------------
--Lymetutu--
Opinions, not medical advice!

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RDaywillcome
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http://cid.oxfordjournals.org/content/52/suppl_3/s253.full
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randibear
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Yeah thats the kicker...fine for a vaccine and lets not forget all those nasty side effects...but if you're already sick getting. A vaccination could drive you off a cliff and kill ya!!!

--------------------
do not look back when the only course is forward

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Judie
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"Prevent???? But what if you already have it???"

That's exactly what I thought when I read this.

So many people also have undiagnosed Lyme. What will happen to them if they get the vaccine???

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Lymetoo
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quote:
Originally posted by Judie:

So many people also have undiagnosed Lyme. What will happen to them if they get the vaccine???

-
That's what I think happened to a lot of people who got the Lymerix back in the early 2000's.

They say that those who got Lyme from the vaccine have a really recalcitrant case as a result.

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--Lymetutu--
Opinions, not medical advice!

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Eight Legs Bad
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Borrelia are infamous for their ability to undergo antigenic variation; this fact alone indicates that the vaccine is likely to fail.

Add to it the fact that we know that OspA has enormous heterogeneity among strains of Bb sl, especially in Europe. In other words, different strains have a different genetic make-up, which means that even if your immune system makes antibodies to what is in the vaccine, you may then get bitten by a tick who neglected to check which genotype your antibodies act against before infecting you.

Let's add to that the evidence that OspA cross-reacts with proteins in human nervous tissue.

Let's remember all the people who were harmed by the last OspA vaccine, so much so that a class action forced it off the market...

And finally, let' recall that the latest information shows that people can get sick as dogs with Lyme-like illnesses from Borrelia that are **NOT in the BURGDORFERI GROUP AT ALL". Some borrelia, like B. miyamotoi, are closer to relapsing fever genetically speaking. OspA is definitional for B. burgdorferi. So if it's not in the burgdorferi group (Bb sl), it **doesn't have OspA** on its surface at all! And hence any immunity derived from an OspA vaccine would be totally irrrelevant.

Still, I don't doubt that Baxter have some knowledge of Borrelia. After all, they are one of the descendants of the corporation set up by biological warfare scientists from the Japanese Unit 731, war criminals who are estimated by to have killed up to half a million people (mostly Chinese)during the Second World War, as a result of aerial biowarfare attacks and horrific experiments on men, women and children. They were protected, exonerated and recruited by the US government after the war, who brought their knowledge to places like Plum Island. Meanwhile back in Japan, these monsters made a great living making vaccines for the weapons they had created.

Elena Cook
For more info:
http://www.elenacook.org/spirowarfare.html

--------------------
Justice will be ours.

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Keebler
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Elena,

Thanks so much for your post. It's so good that you added these very important details.
-

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Eight Legs Bad
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You're welcome. Oh, and let's not forget a few of Baxter's friends:

"Potential conflicts of interest. G.P.W.[Gary Wormser] has received consulting fees from Baxter and research support from Immunetics, and he is a founder of Diaspex, a company that does not offer products or services.

" R.J.D.[Ray Dattwyler] has served as a speaker for Pfizer and is part owner of Biopeptides, a biotech company that develops vaccines and laboratory diagnostics, including products for Borrelia burgdorferi.

" J.J.H.[John Halperin] has served as an expert witness on behalf of Lymerix (GlaxoSmithKline). A.C.S.[Allen Steere] has received consulting fees from Baxter. P.J.K. has a patent pending with a university on a babesiosis diagnostic procedure that is not yet on the market. All other authors: no conflicts."
Elena


quote:
Originally posted by Keebler:
-
Elena,

Thanks so much for your post. It's so good that you added these very important details.
-



--------------------
Justice will be ours.

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Keebler
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-
While Eight Legs Bad (Elena) posted excellent and articulate detail, I'll add some thoughts I just posted as another thread of this same topic.

To any newcomers here:

Do not get a lyme vaccine. Although it's not available now, even the new one is not to be trusted UNTIL much more research has been done.

The previous vaccine here in the US a few years ago, CAUSED lyme in many who took it. And their symptoms, their disabilities, their horror was ignored, discounted and dismissed.

Some of the same financial interests are now just trying to tweak that but the politics still run deep and their knowledge of lyme is really not what it should be at all.

The complexities are astounding and they do not grast that. They do get the issue with multiple strains, at least the concept. But other issues are still of concern.

But TRUST is the big issue here.

Trust an ILADS educated lyme literate MD or ND to guide you if there is every a time this is considered - or if, by some chance, you stumble upon someone wanting to give you the previous version. It's supposed to be off the market but I don't trust that there is not still some of that running around somewhere.

Now, when all is said and done, there may come a time when a vaccine may be of help. But do not rush to be the first in line. Consult with an ILADS educated LL doctor or researcher first.

Of vital importance is following all the test subjects for a few years.

But we won't know if any becomes ill and if they do, it will likely be ignored as in previous attempt because chronic lyme is just not even acknowledge and many symptoms of lyme are discounted. So the researchers may not even understand what they see. They have not before.

And, always remember that a tick can be infected with many different bacteria, viruses, parasites. Lyme is terrible, of course and if we could knock that down, all the better - if done safely (unlike the most recent attempt).

Also to consider: additives in any vaccine such as mercury (never good), formaldehyde (also never good), etc.

I'm hoping they consider all that, too. I wish all vaccine makers would but so far they do not think it is important.

Scroll back up to read - copy & paste to your computer files - the posts by Eight Legs Bad. Those posts are very important.
-

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Keebler
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-
http://cid.oxfordjournals.org/content/52/suppl_3/s253.full

Vaccines against Lyme Disease: What Happened and What Lessons Can We Learn?

-------------------

So that no one misses this: RDayWillCome posted the link above and I skipped over it the first time. Be sure to see this. About 3/4 of the way down:

They blame failure of previous attempts on: "advocacy groups" misleading a dumb public (paraphrased) &

What they've learned for the next time is: better marketing, basically.

Do copy and paste to research files for safe keeping, though. The thought process behind this is simply amazing, in a very scary way.
-

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Lymetoo
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It sure won't protect anyone from babesia, ehrlichia, bartonella, RMSF, etc .. on and on. Lyme is only one part of the mix.

--------------------
--Lymetutu--
Opinions, not medical advice!

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