The first results of the vaccine in experimental animals were successful, and the first phase of a clinical trial in humans A vaccine that gives immunity to people against high cholesterol and the stenosis of the arteries because of it, is now delineated on the horizon – though not in the nearby. The first results of the vaccine in experimental animals (mice) were successful, and the first phase of a clinical trial in humans has recently begun.
The researchers published the publication in the European Heart Journal of the European Society of Cardiology. The vaccine, with the temporary name AT04A, is being developed by the company and the AFFiRis research institute in Austria, led by Dr. Günter Stafler. Recent studies have shown for the first time that it is possible to activate the immune system via a molecule to produce antibodies against the PCSK9 enzyme that prevents the removal of “bad” cholesterol (LDL) from the blood.
People with high levels of LDL, either for genetic reasons or because of poor diet and lifestyle, are more likely to develop cardiovascular disease prematurely due to lipid deposition and atherosclerosis induced. Medicines like statins reduce “bad” cholesterol, but they have to be taken daily and can cause side effects in some people. A new class of drugs, the monoclonal antibodies that target the PCSK9 enzyme, are effective, but expensive, and their activity is short-lived.
That is why other solutions such as a vaccine are being sought. ATROA assays in mice showed that the subcutaneous vaccine reduced total cholesterol by 53%, LDL by 50%, atherosclerotic damage in the blood vessels by 64%, and inflammation in the vessels up to 28%, compared to untreated experimental animals.
“If these results are successfully translated into humans, this will mean that as the antibodies remain for months after vaccination, we could develop a long-term treatment that will only need an annual repeat after the initial vaccination “Said Dr Stafler.
The PCSK9 enzyme is produced in the liver and “locks” onto LDL receptors, thereby reducing their ability to drive “bad” cholesterol out of the blood. The AT04A vaccine pushes the body to produce antibodies that block the enzyme in question, so that the activity of LDL receptors increases and “bad” cholesterol is easier to remove from the blood.
As the researchers have said, the difference between a conventional vaccine and AT04A is that the former produces antibodies against certain bacterial proteins and viruses that have invaded the body, while the cholesterol vaccine produces antibodies against an endogenous target protein, Which the body itself produces.
The first phase of the clinical trial of the cholesterol vaccine in 72 healthy people started in 2015 at the Department of Clinical Pharmacology of the Vienna Medical University. The test is expected to be completed by the end of 2017 and the results are expected with interest.
It will take at least six years, however, until scientists are satisfied that such a vaccine is indeed safe and effective for humans. One suspicion is that it could increase the risk of developing type 2 diabetes. And in any case, the researchers say, the vaccine should not be an “alibi” in order not to exercise people or to eat fatty foods without guilt. .