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Institute of Health ': EXPLAIN WHAT' THE INFLUENCE SQUALENE

Professors Antonio Cassone and Giovanni Rezza (in photo at right), eminent experts in the Department of Infectious, Parasitic and Immunomediated 's Institute of Health (public corporation that, as an organ of the Scientific and Technical Service Italian National Health, performs functions research, experimentation, testing, consulting, and training in public health) in this article explain what exactly is the squalene.

The squalene, a substance that until a few months ago was only known producers of influenza vaccines and some expert biochemist has become the substance of which it is now said, almost always inappropriately, even in local markets. The name is clearly evocative of a dangerous animal tropical seas but the substance itself is the most organic and natural exists: it is actually a compound essential for life as it is used by the body as a "brick" to build steroid hormones and other lipid substances. In particular, the ' crucial intermediate for the synthesis of cholesterol that occurs in the liver, according to the following reaction :

2 → farnesyl pyrophosphate → squalene lanosterol cholesterol →

E' has been shown that the skin it secretes human sebum in a certain amount, in fact, they were no traces in the secretion released by human footprints.

molecule squalene (Molecular formula: C 30 H ₅₀ )

But we are certainly not the only ones squalene in the body : plants and animals use them and there is enough metabolic egg, in the flesh in olive oil and (where present up to 0.7% ) in a concentration relevant to a metabolic intermediate, a substance capable of counteracting the harmful effects of cholesterol . In the United States

was calculated that of squalene he eats with the normal diet about 25 mg per day . The squalene can be very common in cosmetics such as mascara , lipstick and talcum powder , up to very high concentration (50%) , what makes a substance released into the environment and thanks to the fact that this compound is easy to remove (especially some species of sharks), purify and obtain in quantity, it was decided in immunology to focus on this substance as an adjuvant.

Moreover, in many normal individuals were detected small amounts of antibodies to squalene in , as for anti-cholesterol , you do not know neither the source nor the biological significance , although it has been hypothesized that these antibodies will help to remove the "bad" (LDL) cholesterol from the blood through opsonization and phagocytosis.

L ' of vaccine use squalene stems from observations that emulsions and lipid substances in water are potent stimulators of innate immunity. The precursor of these emulsions is well known incomplete Freund Adjuvant, used by virtually all immunologists to get good antibody responses to soluble antigen in experimental models. At very low doses (micrograms) the emulsion of squalene in water cells potently activates antigen-presenting cells to , particularly dendritic cells, which then secrete cytokines that address antibody responses and / or cytotoxic to the target antigen . Experimental studies have shown that the squalene in water emulsion is superior to aluminum salts as adjuvant of antibody response.

Both clinical trials that immunological surveillance data show the vaccine ' high capacity of this adjuvant in enhance the antibody response against the flu virus, allowing a significant amount of savings of antigen used.

Two adjuvants based on squalene have been approved for use in influenza vaccines in Europe and other pharmaceutical companies that produce vaccines they are experimenting with different formulations.

As is standard in immunology, stimulation powerful immunological responses has its counterpart in 'evocation of associated inflammatory responses.

Vaccines formulated with squalene in water emulsions have a relatively greater toxicity and local reactogenicity of vaccines without emulsions, even if it is, in most cases, transient events and limited to the first 2-3 days after vaccination.

These inflammatory events may affect up to 30% of vaccinees. In addition to pyrexia and headache, seen in about 20% of vaccinees, the most frequent systemic event is altralgia / myalgia observed in 15% of vaccinees, reminiscent induction of experimental arthritis in animals genetically susceptible.

However, adverse events and serious non-transient such events requiring hospitalization and death neuropathies are very rare and are most common in persons receiving vaccines with squalene in relation to people receiving vaccines without adjuvant. Data from the surveillance system for adverse reactions AIFA collected during the current vaccination against the H1N1 virus of 2009, at the time, perfectly in line with what is expected from the results of clinical trials of Focetria.

In conclusion, squalene is a natural compound that used artificially as an emulsion in water and injected intramuscularly is a powerful adjuvant that allows an effective immunization , usually with a single dose vaccine (at least in adults), at low cost in terms of local tolerability and effects generally mild and transient systemic .