In a follow-up on the progress on French company, Valneva’s Lyme disease vaccine candidate VLA15, the company expects to launch a Phase 2 study in the second half of 2018, subject to regulatory clearances, after reporting positive Phase 1 interim data for the vaccine candidate in March 2018.
Phase 2 is intended to be conducted in Lyme-endemic regions in the US and Europe and will include subjects previously infected with Borrelia, the bacteria that causes Lyme disease. Further dose and schedule optimizations are being considered.
As part of its development acceleration strategy, Valneva has elected to augment the Phase 1 study with a booster dose, to gather additional data expeditiously.
A subset of subjects in the higher dose groups who received a complete primary immunization schedule (three vaccinations), will be included in a booster extension to investigate the safety and immunogenicity of a booster dose of VLA15 administered approximately thirteen months after the first immunization. An analysis on safety and immunogenicity will be performed after the last subject has completed the last study visit six months after booster vaccination. In addition, an interim analysis on immunogenicity data one month post booster will be performed.
Lyme disease is the most common and one of the fastest growing vector-borne illnesses in the Northern Hemisphere for which there is no other clinical vaccine candidate in development worldwide.
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12 thoughts on “Lyme disease vaccine Phase 2 study slated for second half of 2018”
How many researchers involved in this “vaccine” have knowingly and deliberately falsified their research, perjured themselves, and committed medical research fraud, at the behest of the CDC and IDSA, and also with their blessing, as well as with carte blanche immunity from federal investigation and prosecution?
No one ? You know vaccines work don’t you ? Ignore the woo-woo. They work, they save lives.
You know nothing about spirochetes or the way vaccines work, or rather have no possibility of working with a spirochetal infection, Steve. The last Lymerix vaccine was pulled from the market after it INFECTED people with Lyme Disease, yet the CDC not only refuses to admit that fact but refuses to admit that Lyme is a chronic, crippling disease, period. The treatment guidelines were written by four strongly biased infectious disease doctors with financial conflicts that should’ve exempted them from input, just as the CDC and IDSA are not the white knights of medical research. They are political arms of the government, not the citizens. It is not possible to vaccinate against an organism that shape shifts and reproduces by splitting. By all means line up and put your life and the lives of your family in the hands of Valneva. And don’t say you weren’t warned.
Lymerix was pulled because conspiracy theorists and quacks, and those who parrot them (like yourself), created a media scare which they thought would kill demand. As a result, millions of Americans now suffer from the (sometimes debilitating) effects of undiagnosed or chronic cases of Lyme, and tens of millions of others have to fear for themselves and their children when going outside. We all could have had a vaccine nearly two decades ago if it weren’t for ignorant, loud-mouthed, and mentally deranged people like yourself. I certainly hope you’re proud of yourself.
You could not be more wrong!
Lymerix ruined my good health and that of many others. I have never recovered. That is why it was taken off the market, not because of lack of interest as they have stated. If it was safe, they would have brought it back, don’t you think?
Looks like the crooks at the CDC/IDSA have patiently waited 20 years to get rich off this ridiculous “vaccine” and are now rebooting LYMErix. I was wondering why over the last few weeks there have been so many “news” articles published defending a 20 year old failed vaccine that no one even remembers, but now I see why. They must be trying to get ahead of any possible negative publicity by defending LYMErix and claiming it was “anti-vaxxers” that got it removed from the market. Yes, big pharma does what anti-vaxxers tell them to do….lol. Don’t think I’ll be lining up for a big dose of OspA, as delicious as it sounds….
I had 3 courses of LymeRix (the Lyme vaccine) that was taken off the market which either accelerated something in me that I didn’t know about or caused the disease it was supposed to protect me from, although they will tell you it was taken off the market due to “lack of interest”. I went from healthy and active and with each shot, I became progressively worse with full-blown Lyme issues and never recovered. There are many of us out there with the same experience. There was a failed class action suit (which I was not a part of) against the company Smith-Kline that produced it and I believe the CDC protected them and had them quietly remove LymeRix from the market. I want you to be aware that there were problems with that “vaccine”.
I’ve been exposed to ticks all my life. I grew up loving nature, hiking and being in the woods so I thought it would be a good idea to be vaccinated. Biggest mistake of my life.
After a company spends millions of dollars on R & D, testing (faulty, as I know now) and marketing no company would take this off the market due to “lack of interest”. If that was true, they would bring it back, there is no “lack of interest” now. There is a history of why the CDC, the medical community, and the insurance companies dropped the ball on Lyme and it needs to be known. Here is a start if you are interested because it affects all of us. https://lymecryme.wordpress.com/2017/04/15/they-literally-changed-the-definition-of-lyme-disease/