Lyme disease
is a tick-borne zoonosis caused by infection with the spirochete,
Borrelia burgdorferi.. The number of annually reported
cases of Lyme disease in the United States has increased about
25-fold since national surveillance began in 1982, and a mean
of approximately 12,500 cases annually was reported by states
to the Centers for Disease Control and Prevention (CDC) from
1993 - 1997 (1, 2). In the United States, the disease is mostly
localized to states in the northeastern, mid-Atlantic, and upper
north-central regions, and to several counties in northwestern
California.
Lyme disease
is a multi-system, multi-stage, inflammatory illness. In its
early stages, the disease is readily cured with oral antibiotics;
however, untreated or inadequately treated infection may progress
to late-stage rheumatological or neurological complications requiring
more intensive therapy. The first line of defense against Lyme
disease and other tick-borne illnesses is avoidance of tick infested
habitats, use of personal protective measures such as repellents
and protective clothing, and checking for and removing attached
ticks. Early diagnosis and treatment prevents late-stage complications.
Two Lyme disease
vaccines have recently been developed using recombinant B.
burgdorferi lipidated outer surface protein A (rOsp A) as
immunogen (LYMErix™, SmithKline Beecham Pharmaceuticals;
ImuLyme™, Pasteur MŽrieux Connaught). At this time,
only LYMErix™ has been licensed by the Food and Drug Administration
for use in the United States, and these recommendations apply
only to the use of this vaccine. Supplemental statements will
be provided as additional Lyme disease vaccines are licensed.
Results of
a large-scale, randomized, controlled (Phase III) trial of safety
and efficacy of LYMErix™ in persons residing in endemic
areas of the northeastern and north-central United States indicate
that the vaccine is safe and efficacious in persons aged 15 to
70 years when given in a 3-dose schedule at 0, 1, and 12 months
(3, 4). Information on vaccine safety and efficacy beyond the
transmission season immediately following the third dose is not
available, thus the duration of protective immunity and need
for booster doses beyond dose 3 are not known.
