Abstract
Squalene is a naturally occurring oil which has been used in the development of vaccine adjuvants, such as the oil-in-water emulsion MF59. In past years, by use of noncontrolled and nonvalidated assays, a claim was made that antisqualene antibodies were detectable in the sera of individuals with the so-called Gulf War syndrome. Using a validated enzyme-linked immunosorbent assay for the quantitation of immunoglobulin G (IgG) and IgM antibodies against squalene, we demonstrated that antisqualene antibodies are frequently detectable at very low titers in the sera of subjects who were never immunized with vaccines containing squalene. More importantly, vaccination with a subunit influenza vaccine with the MF59 adjuvant neither induced antisqualene antibodies nor enhanced preexisting antisqualene antibody titers. In conclusion, antisqualene antibodies are not increased by immunization with vaccines with the MF59 adjuvant. These data extend the safety profile of the MF59 emulsion adjuvant.
Highlights
Squalene is a triterpenoid hydrocarbon oil (C30H50) produced by plants and is present in many foods
Using a validated enzyme-linked immunosorbent assay for the quantitation of immunoglobulin G (IgG) and IgM antibodies against squalene, we demonstrated that antisqualene antibodies are frequently detectable at very low titers in the sera of subjects who were never immunized with vaccines containing squalene
Squalene is produced abundantly by human beings, for whom it serves as a precursor of cholesterol and steroid hormones [8] It is synthesized in the liver and the skin, transported in the blood by very-low-density lipoproteins (VLDL) and low-density lipoproteins (LDL), and secreted in large amounts by sebaceous glands [10, 17]
Summary
Squalene is a triterpenoid hydrocarbon oil (C30H50) produced by plants and is present in many foods. Despite the fact that vaccines given to veterans returning with Gulf War syndrome did not contain squalene [6] and despite that fact that symptoms similar to those of the so-called Gulf War syndrome have been reported after several wars, including the American Civil War [9], we decided to undertake a study to determine whether immunization with the influenza vaccine with the MF59 adjuvant stimulated antibody responses against squalene. We conclude that antisqualene antibodies are found very frequently at low titers in sera from healthy, unvaccinated adults and that vaccination with influenza vaccine with the MF59 adjuvant does not result in any measurable impact on these antibody titers
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