- January 8, 2013 at 7:04 pm #93907
ChevyG20MemberTopics: 5Replies: 6
NovaDigm announces data from NDV-3 vaccine Phase 1 study on Candida and Staph infections
Published on December 13, 2012 at 11:58 PM · No Comments
NovaDigm Therapeutics, a company developing innovative vaccines for fungal and bacterial infections, today announced the publication of data from its first-in-human Phase 1 study of its NDV-3 vaccine program in the journal Vaccine. The data demonstrate that a single dose of NDV-3 with alum adjuvant was safe, well-tolerated and induced strong antibody and T-cell immune responses in healthy adults.
NDV-3 is a vaccine being developed for the treatment and prevention of infections caused by the fungus Candida and the bacterium Staphylococcus aureus (including methicillin-resistant S. aureus, or MRSA). NDV-3 is the first vaccine to demonstrate preclinical “cross-kingdom” protective efficacy against both fungal and bacterial pathogens.
“The publication of this positive data provides further validation for NovaDigm as we prepare to begin a Phase 2 efficacy study with an optimized vaccine formulation in the first half of 2013,” said Timothy Cooke, Ph.D., NovaDigm’s Chief Executive Officer. “We are encouraged that NDV-3 was shown to be safe and well-tolerated, with a very promising immunogenicity profile, in two Phase 1 studies. We are confident that it can play an important role in treating community- and hospital- acquired infections caused by these pathogens, which represent significant medical needs and large commercial potential.”
“There is a great need for vaccines that can safely treat the wide array of infections caused by both Candida and Staph aureus,” commented John Hennessey, Ph.D., corresponding author of the study and Vice President of Research & Development at NovaDigm. “In addition to the rapid antibody responses following a single dose, there were also substantial T-cell responses. These included responses to Th1 and Th17 T-cells, which are believed to be important for protection against both Candida and Staph aureus. This study is also the first to demonstrate vaccine-induced Th17 responses in humans.”
The objectives of this first-in-human Phase 1 clinical trial were to evaluate the safety, tolerability and immunogenicity of NDV-3 at two different antigen levels compared to a saline placebo. Forty healthy, adult subjects were randomized to receive NDV-3 containing either 30 µg or 300 µg of the Als3 antigen with alum adjuvant or placebo. The trial data published in Vaccine indicated that NDV-3 was safe and well-tolerated after one or two doses, with the most common adverse event being injection site pain that was typically mild and lasted 1 to 2 days after vaccination.
Both dose levels resulted in 100% seroconversion for both serum immunoglobulin G (IgG) and serum immunoglobulin A1 (IgA1) antibodies by day 14, with greater than 50% seroconversion by day seven in the higher dose group. The geomean fold rise in IgG and IgA1 antibody titers by day 14 post-vaccination for the higher dose group were 65- and 45-fold, respectively. Geomean IgG and IgA1 titers over the course of 28 days were significantly greater in the 300 µg dose level compared to the 30 µg dose level. Results of the study showed that the majority of subjects that received NDV-3 demonstrated significant Als3-stimulated production of the cytokines IL-17A and IFN-γ between seven and 28 days post-vaccination relative to subjects receiving placebo.
The article, titled “NDV-3, a recombinant alum-adjuvanted vaccine for Candida and Staphylococcus aureus is safe and immunogenic in healthy adults,” was published in the current print issue of the journal Vaccine (Volume 30, Issue 52, December 14, 2012). The study’s authors were: Clint S. Schmidt, C. Jo White, Ashraf S. Ibrahim, Scott G. Filler, Yue Fu, Michael R. Yeaman, John E. Edwards Jr. and John P. Hennessey Jr.
Top-line results reported in May 2012 from a second Phase 1 trial in 160 volunteers showed that single doses of three different formulations and two routes of administration of NDV-3 were safe, well-tolerated and highly immunogenic. The Company believes the two Phase 1 studies provide a strong foundation for further clinical development. NovaDigm is preparing to initiate a Phase 2 efficacy trial in 2013 in women with chronic vaginal Candida (yeast) infections.January 9, 2013 at 1:11 am #93945
All vacccines are toxic! They contain farmaldyhide, mercury, aborted fetal tissue, thermasal and honestly would b here all day listing all the chemicals in vaccines!
I would say never get a vaccine ever they cause. The disease they are supposed to prevent, and many other horrible reactions. Our system is set up to keep people sick . Another reason is population control, don’t get any vaccines for u or your children if u want to b healthy, I have a healthy daughter that will never b vaccinated ,its a joke on all of us, a cruel one reallyJanuary 30, 2013 at 6:22 pm #96055
EmsmithParticipantTopics: 25Replies: 137
Why is thiomersal added to vaccines? Well, two reasons actually. The first is preservation. Without thiomersal, vaccines would disintegrate quite quickly. That would of course be very good for the pharmaceutical companies, because lots of vaccine would have to be thrown away and re-purchased. Yet, the choice was made to add thiomersal, thereby increasing the lifetime of the vaccine. This is of course a boon to the population, even if it’s a negative for the pharmaceutical companies.
The second reason for adding thiomersal is that it greatly increases the effectiveness of the vaccine. In other words, without thiomersal, doctors would have to inject much more of the actual vaccine stuff. That, in turn, would result in much more severe reactions of the body. The addition of thiomersal therefore results in a very good effect, without making us feel sick from the vaccination.
The story about the aborted fetal tissue is just plain nonsense. Sorry for these harsh words, but that’s how it is.
Actually Thimerosal is added to larger vials that cost dr’s less money than a single vial without thimerosal. It doesn’t increase the lifetime of the vaccine, but it allows someone to enter multiple times into that larger vial. The thimerosal free flu vaccine is not any less effective and actually the dose is exactly the same 0.5ml for both the flu vaccine with or without thimerosal. And there are no more severe reactions from the preservative free flu vaccine than there are with the regular. But if you’re pregnant most good doctors will recommend the one without just like you would avoid sushi if pregnant. So I’m not sure what good effects you think thimersal brings us; I see that it keeps the cost lower so more providers can inject more of the population. Almost every child I know that has received the flu vaccine has has far worse complications than the ones that didn’t receive the injection. Now here is a link that describes the aborted fetal proteins and genetically modified human albumin in vaccines… http://www.naturalnews.com/038873_childhood_vaccines_aborted_babies_DNA.htmlJanuary 31, 2013 at 4:33 am #96106
KagMemberTopics: 18Replies: 402
I have read a lot of stuff about yeast and systemic infections. I think for someone suffering from a life threatening candida infection, this vaccine would be a Godsend. I don’t necessarily go in for vaccines but they are talking about MRSA and Candida that is resistant to everything else. I would think that anyone who had that would thank their lucky stars for a chance to stay alive. I could be wrong, and often am, but I don’t think this vaccine is for the average person with candida problems.January 31, 2013 at 12:42 pm #96144
mrs.candidaMemberTopics: 53Replies: 453
really? I thought that everyone knew that Dr.Wakefield had manipulated his tests.
I come from the school that I would like to believe that vaccines are dangerous, but science has thus far proven my hunch wrong.February 1, 2013 at 6:14 pm #96226
KagMemberTopics: 18Replies: 402
I think the idea with vaccines is that you have to weigh the good against the bad. My situation with yeast is not bad enough that I would consider a vaccine, but if it were life threatening, I would. There are always going to be a certain group of people that react poorly to vaccines. They may be allergic to something in the suspension that carries the vaccine, there could be an abnormal immune response. I think vaccines are very important in some cases, in others, perhaps not so much. It is important I think to view each indivdual situation instead of saying, “Vaccines don’t ever do this” because sometimes they will have adverse effects. However, it is important to remember that even natural products can cause very severe, even life-threatening reactions in a subset of people. The key here is, everybody is different. We are not one homogenous population where a vaccine is always going to work and always be safe. It is just not possible.February 1, 2013 at 9:55 pm #96252
unlike u i dont believe or trust in media hype i get my news from independent media sources like ww.blacklistednews.com or http://whatreallyhappened.com/ and many others .It seems u are the one afraid .I think vaccines destroy the immune system and are the cause of not only autism but many other diseases .It is the combination of all of them at once and the combination of the chemicals that cause these reactions and deaths .
Before the 80s we were not givin so many vaccines and there wasent over 30 different toxic chemicals in them either !Autism is a new disease that came out soon after they added to the vaccination schedule .There was no epidemic or other reason for this my personal belief would be that it is a way to decrease population .
Ive seen my baby healthy while other vaccinated babies unfortunately have the flu ,breast feeding is the only way to ensure a babies immune system vaccines do nothing but harm their bodies with chemicals hazardous to their health .There even trying hep b vaccines in hr old newborns out the womb !!!!
If thats not a red flag i dont know what is i could post a ton of statistics on the dangerous substances ,infant deaths ,autism ,but it is a matter of opinion so im not wasting my time .I will just say its rude to assume i am not religious and am afraid as i am in fact religious and it certainly seems u are afraid with all your talk about how unvaccinated people are going to spread disease I dont know what u got that from lol but the truth is vaccines are not necessary and damage the immune system
Syphilis was injected and created thru a vaccine ,aids was given to children in Africa thru a vaccine , i know more kids and people who got the flu shot and then got the flu the nxt day its ridiculous !February 1, 2013 at 10:14 pm #96258
well u are a sheep idiot who believes what the Government and mainstream media tells them instead of doing the research and forming your own opinion u listen to what others tell u .i have done the research and thats how i know the only latest people that got polio were vaccinated .why argue whats fact i dont have time just stating my believe over your assumptions .Have fun with your shots !Inject formaldehyde,mercury,flu virus ,aluminum ,aborted fetal tissue into your blood stream hope it works out for ya .February 1, 2013 at 10:17 pm #96259
just thought id add that i work in health care and never get a flu shot or hep b vaccine !I have seen numerous people infact so many its ridiculous get the flu after the shot while me and my famliy are clear !i take care of elderly patients who get the flu every year even though they got the shot while again me and my fam are clear !February 1, 2013 at 10:35 pm #96261
lol u were the 1st to attack me !Thats why people like u are called sheeple !Hope those shots save u lmao !February 1, 2013 at 11:04 pm #96267
As i stated b4 there is no point in wasting my time posting valuable info for u u will not care to read it .It is pointless to talk to a sheep who follows the heard like u im all set wasting my breath .Just avoid me like i will u from now on .Have a good nightFebruary 3, 2013 at 12:03 am #96348
If u read my posts and the info I provided and disagree then wtf are u still talking to me for? We disagree! We do not share the same believe and as I will proudly advocate that vaccines damage the immune system, cause the disease they are supposed to prevent and autism as well as infant deaths due to the mixture of deadly chemicals and other horrific substances.
U will continue to advocate that the media and gov are in our favor and to listen to them because if they say its safe it is.and whatever the hell else they or society may tell u. Have a blast I don’t care it’s funny 2 me u keep writing back lmao.
Post as much as u want I am only asking u to avoid me cuz we disagree! I will not reply to your posts eitheir even if it’s about how vaccines and flouride are good 4 u LOL. This is surly the last time we will speak so again have a nice day!February 3, 2013 at 2:44 pm #96376
jameskepParticipantTopics: 25Replies: 220
Doctors should have all the ingredients listed that are in a shot and provide them to the patient prior to the shot. Why is it that the ingredients are listed on our food labels but not listed on the shots. The patients should be informed of what is going into their body without having to request a list of ingredients. Most patients are too ignorant or misinformed to request a list of ingredients.
For some a vaccination for fungus could be a big relief, provided that the shots are not loaded with toxic fillers(especially mercury/aluminum). Some people are so sensitive to everything orally that for them a clean vaccination might do some good. Depends on how desperate the person is for some type of relief when they have already tried everything and nothing seems to be helping.
Although, I would not inject my young child with a vaccination that has toxic fillers when their brain is still developing. Especially if it had any mercury or aluminum in it.February 3, 2013 at 5:12 pm #96384
as i stated b4 it is the mix of chemicals in vaccinations and the combination of giving them all at once that causes autism ,adverse reactions and death .
whatever u speak of that happened did not have to do with anyone not receiving a vaccine ,it is impossible to say that vaccines protect or work and injecting the very same disease into your bloodstream for a chance u may get it is insane .The whole idea of vaccinations is outrageous but it is the 30 different chemicals and that they combine vaccines and more than one at once that really causes the deaths and autism .there is no doubt in my mind that more children die from adverse reactions to the mixture of formaldehyde,aluminuim and mercury ,the live virus ,and aborted fetal tissue than ever actually getting the disease the vaccination was for .
As for fluoride they use the chemical in our dental products that is a by factor of aluminum companies in the 40s we all know aluminum in the brain causes Alzheimers .There is a natural fluoride found in the earth that is actually ok but they are not using this in our products .
My advice to anyone stay away from all vaccines ,and fluoride ,breast feed your babies for a good immune system .I have a healthy 19 month old that will never receive a vaccine and know many other babies who get very sick this time of year because of vaccinations lowering there immunity .it wasent as bad when we were lil they are now shooting our babies with hep b out the womb !its disgusting !
there lil infant bodies cant handle all those chemicals plus the live vaccine at once and that how autism began in the 80s with the combinations of vaccines ,it is no coincidence that as soon as they start adding new chemicals and combining more than one vaccine that autism begins !
the immune system protects u from getting sick a vaccine injects numerous toxic chemicals including a live virus into your bloodstream with the attempt u will become immune to that disease,this in fact alters our genetic code as human beings as we are not meant to put this into our bodies .enough said goodbyeFebruary 3, 2013 at 5:15 pm #96385
and james all vaccines have mercury ,aluminum .formaldehyde aborted fetal tissue and many other toxic chemicals not meant for our bloodstream ,unfortunately there isnt a way to get around it i wouldn’t trust what a doctor says or the media either as they are misinformed about these things
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