Antibodies to Squalene in Recipients of Anth

lace, m. ressed adjuvant, are present in persons with symptoms consistent with Gul Syndrome (GWS) (P. B. Asa et al., Exp. Mol. Pathol 68, 196–197, 2000). Th United States Department of Defense initiated the Anthrax Vaccine Im zation Program (AVIP) in 1997 to immunize 2.4 million military person Because adverse reactions in vaccinated personnel were similar to sym of GWS, we tested AVIP participants for anti-squalene antibodies (ASA a pilot study, 6 of 6 vaccine recipients with GWS-like symptoms were po for ASA. In a larger blinded study, only 32% (8/25) of AVIP person compared to 15.7% (3/19) of controls were positive ( P 0.05). Furthe analysis revealed that ASA were associated with specific lots of vaccin incidence of ASA in personnel in the blinded study receiving these lots 47% (8/17) compared to an incidence of 0% (0/8; P 0.025) of the AVIP participants receiving other lots of vaccine. Analysis of additional pers revealed that in all but one case (19/20; 95%), ASA were restrict personnel immunized with lots of vaccine known to contain squalene. E for one symptomatic individual, positive clinical findings in 17 ASA-nega personnel were restricted to 4 individuals receiving vaccine from lots co ing squalene. ASA were not present prior to vaccination in preimmuniz sera available from 4 AVIP personnel. Three of these individuals became positive after vaccination. These results suggest that the production of A GWS patients is linked to the presence of squalene in certain lots of a vaccine. © 2002 Elsevier Science (USA)