Success in the Phase A/B clinical trial of Biondvax for a universal flu vaccine: Biondvax's vaccine was found to be active in both arms of the human immune system and produced a high level of antibodies in the blood of all trial participants
The BiondVax company, which develops a universal flu vaccine, reports the success of the Phase I/II clinical trial of the second generation of the universal flu vaccine (the multimeter vaccine) which it conducts at the Tel Aviv Sourasky Medical Center.
In the experiment it was found that the vaccine developed by Biondvax was safe to use in all the doses given, both with and without an adjuvant. In addition, it was found that the vaccine activated, in a statistically significant way compared to the control group, the two arms of the human immune system - the antibody arm and the cellular arm - and in the blood of all the participants who received the vaccine, a high level of antibodies against the universal vaccine was formed. These antibodies also specifically recognized several strains of influenza, including the swine flu strain (A/H1N1).
A total of 60 people aged 18-49 participated in the phase I/II clinical trial who received injections without adjuvant or with adjuvant in the various doses. As part of the experiment, cellular parameters were also tested, and it was found that the vaccine stimulated, in a statistically significant way compared to the control group, a significant proliferation of white blood cells of the immune system and caused them to secrete INTERFERON-GAMMA - and INTERLEUKIN-2 substances that are secreted by the immune system as part of the body's cellular defense system against Disease factors. This cellular response distinguishes the universal vaccine that Biondvax is developing from the existing seasonal flu vaccines, which are tested according to their ability to elicit primarily an antibody response.
It was also found that the universal vaccine developed by Biondvax stimulated antibody and cellular immune responses against both types of influenza - both influenza type A and influenza type B (which include all types of influenza that cause morbidity in humans). This, unlike other universal vaccines that are in development stages, which to the best of the company's knowledge, in accordance with scientific and other publications, are intended to provide protection against type A influenza only.
As part of the experiment, it was found, in a statistically significant way compared to the control group, that the highest immune efficiency was observed at the highest dose, with the adjuvant, which was injected into the participants in two doses. It was also found that even in the dose injected without adjuvant, in two conditions, significant reactions with statistical significance were found.
This experiment is the first of two experiments conducted by Biondwax, with the second experiment already started and being carried out among 60 participants in the age group of 55-75 is expected to end in the first quarter of 2010.
The universal vaccine is designed to provide a full response to deal with all strains of the flu, as well as the mutations of the virus, and is based on studies led by Professor Ruth Arnon that were carried out at the Weizmann Institute of Science for more than 15 years before the founding of the company. Professor Arnon is a world-renowned scientist, a laureate of the Israel Prize and is considered a world expert in immunochemistry. Professor Arnon carried out pioneering studies that led to the use of synthetic molecules in the study of immunology, and successfully developed, together with the former president of the Weizmann Institute Professor Michael Sela, the drug for the treatment of multiple sclerosis, "Copaxone", which is produced and sold with commercial success worldwide by the Teva company. Professor Ruth Arnon chairs Biondwax's Scientific Advisory Committee.
Dr. Ron Babkov, CEO of Biondvax, states that "We are very proud of the success of the phase I/II trial in the second generation of the universal flu vaccine and the initial proof of the effectiveness and safety of our vaccine. The results obtained in the experiment are an important indication and an important landmark towards the realization of the company's vision to ensure protection against all influenza diseases by a single vaccine. Such a vaccine will replace the need to be re-vaccinated every year as required by the current vaccine."
Dr. Tami Ben Yedidiya, the company's chief scientist, states that "the success in the trial proved that the multimeter vaccine contains all the components that provoked a reaction against the virus in humans and this is an important achievement, which must continue to be thoroughly examined also in the framework of the continued clinical trials that will be conducted."
Biondvax has a global and exclusive license agreement with Yeda, which promotes applied research at the Weizmann Institute, in favor of the development, production and marketing of vaccines based on patents from the research of Professor Ruth Arnon.
Biondvax has been engaged in the research and development of vaccines against seasonal flu and avian flu since March 2005. The company is working to prove a universal and innovative vaccine against most types of flu that will provide multi-season and multi-strain protection against existing and future flu strains. The company is developing the Multimeric Flu Vaccine, which is the second generation of the vaccine, and recently the possibility of developing a third generation of the vaccine is being examined. The company believes that the knowledge base created and will be created in the development of the vaccine may also be a basis for the development of vaccines against additional diseases in the future.
10 תגובות
Eddie:
I'm sorry. Maybe now you understand the importance of the matter, but your previous statement indicates that you did not understand it before.
If you read the article carefully you would also see that it is still not possible to determine the effectiveness of the vaccine based on the magnitudes of the experiments that have been carried out. The work has not yet reached this stage.
A universal vaccine is of enormous importance even if its effectiveness is less than this or that specific vaccine and this is because it is immediately available - even before the development of the specific vaccine is completed.
This brings me to the next point which is even more important: I said "before the development of the specific vaccine has been completed" but an assumption is implicit here that there is no certainty behind it! It is not at all certain that the specific vaccination will be completed!
This in turn brings me to the real absurdity of your words: I wonder how you want them to predict the effectiveness of vaccines that do not yet exist and their development has not yet begun! After all, this is the type of vaccines you want to compare to because the intention is to fight the next war and not the previous one!
Michael Rothschild:
After all, no one disputes that this is a universal vaccine, which may be of enormous importance. You are not the only one who read and understood this.
But if you read my words carefully - it should have been clear to you that this is not the case!
The question I asked is simple: Is the supposed universal vaccine more effective than any of the specific vaccines?
The issue is clear: if so - the breakthrough is real. If not - we will continue to need the separate vaccines, and the idea of the universal vaccine will be filed away as another nice idea that failed to come to fruition.
What the article hides - mostly verbal fat - is exactly the answer to the above simple question. It is likely that universal vaccination has not yet reached relative priority, and it is not clear if it will even reach that point. So what's the problem with stating it explicitly? What is the problem with pointing out the relative inferiority, which exists today, along with hope for the most positive scenarios with the continuation of the experiments - and an estimate, at least with an intelligent guess - of the possibility of reaching this? What, is it a shame not to invent every Monday and Thursday an Israeli 'breakthrough' at the level of eligibility for a Nobel Prize (and by a female scientist)?
And why should an article on a scientific website be written like an advertisement leaflet and as a promo for a sales promotion campaign and/or to create an atmosphere of prestige for any business company or any scientist?
Eddie:
After all, you need to read carefully!
This is a universal vaccine - not one that needs to be developed anew every year.
If the development and all stages of the experiment are completed successfully, this will be a very important breakthrough.
Anyway, beyond all the talk about 'definite effectiveness', etc., etc. - is this vaccine better or less good than any of the specific vaccines?
If so - say it simply, with numbers, so that we will be convinced and happy and also so that we will be truly educated.
If not - say so simply, and it is not a shame to express hope that in the future priority will be achieved over the other, specific vaccines. And in the meantime, in order to save the unnecessary verbal 'fat'.
I agree with 4…
This flu is just another version of "opium for the masses"
What did 4 mean?
I wonder who is pushing these articles?
It's starting to stink here
For me too 🙂
For me, she could be the next candidate for the Nobel Prize
Peace,
A layman's question: It was said that it might be possible to create vaccines for other diseases in the future.
Is it also for malaria?
If so, or not, which diseases have the potential to create a vaccine?