Antibodies to squalene in recipients of anthrax vaccine.
Asa PB, Wilson RB, Garry RF.
Department of Microbiology, Tulane University Medical School, New Orleans,
Louisiana 70112, USA.
We previously reported that antibodies to squalene, an experimental vaccine
adjuvant, are present in persons with symptoms consistent with Gulf War Syndrome
(GWS) (P. B. Asa et al., Exp. Mol. Pathol 68, 196-197, 2000). The United States
Department of Defense initiated the Anthrax Vaccine Immunization Program (AVIP)
in 1997 to immunize 2.4 million military personnel. Because adverse reactions in
vaccinated personnel were similar to symptoms of GWS, we tested AVIP
participants for anti-squalene antibodies (ASA). In a pilot study, 6 of 6
vaccine recipients with GWS-like symptoms were positive for ASA. In a larger
blinded study, only 32% (8/25) of AVIP personnel compared to 15.7% (3/19) of
controls were positive (P > 0.05). Further analysis revealed that ASA were
associated with specific lots of vaccine. The incidence of ASA in personnel in
the blinded study receiving these lots was 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 personnel revealed that in all but one case (19/20; 95%),
ASA were restricted to personnel immunized with lots of vaccine known to contain
squalene. Except for one symptomatic individual, positive clinical findings in
17 ASA-negative personnel were restricted to 4 individuals receiving vaccine
from lots containing squalene. ASA were not present prior to vaccination in
preimmunization sera available from 4 AVIP personnel. Three of these individuals
became ASA positive after vaccination. These results suggest that the production
of ASA in GWS patients is linked to the presence of squalene in certain lots of
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