Note: Lyme
disease vaccine does not protect all recipients against infection
with B. burgdorferi and offers no protection against other
tick-borne diseases. Vaccinated individuals should continue to
practice personal protective measures against ticks and should
seek early diagnosis and treatment of suspected tick-borne infections.
Use of the vaccine will not reduce risk among unvaccinated individuals.
Decisions regarding the use of vaccine should be based on individual
assessment of the risk of exposure to infected ticks, and on
careful consideration of the relative risks and benefits of vaccination
compared to other protective measures, including early diagnosis
and treatment of Lyme disease. The risk of Lyme disease is focally
distributed in the United States. A list of the reported Lyme
disease risk in states is relative to the national average is
given in Table 1. A map of the approximate nationwide distribution
of risk is given in Table 1. A map of the approximate nationwide
distribution of risk is shown in Figure 1. Detailed information
on the distribution of Lyme disease risk within specific areas
is best obtained from state and local health authorities.
Persons at
High Risk
Persons at high risk for B. burgdorferi infection are
those who:
- reside, work,
or recreate in areas of high or moderate risk during Lyme disease
transmission season
AND
- engage in
activities (e.g., recreational, property maintenance, occupational,
leisure) that result in frequent or prolonged exposure to tick
infested habitat.
Lyme disease
vaccine should be considered for persons aged >15 years
who are at high risk for B. burgdorferi infection.
Persons at
Moderate Risk
Persons at moderate risk for B. burgdorferi infection
are those who:
- reside, work,
or recreate in areas of high or moderate risk during Lyme disease
transmission season
AND
- are exposed
to tick infested habitat, but whose exposure is neither frequent
nor prolonged.
For persons
at moderate risk for B. burgdorferi infection, Lyme disease
vaccine may be considered, but the benefit of the vaccination
beyond that provided by basic personal protection and early diagnosis
and treatment of infection is uncertain.
Persons at
Low or No Risk
Persons at low or no risk for B. burgdorferi are those
who:
- do not reside,
work, or recreate in areas of high or moderate risk during Lyme
disease transmission season.
as well as those who
- do reside,
work, or recreate in areas of high or moderate risk during Lyme
disease transmission season BUT have minimal or no exposure to
tick infected habitat.
Lyme disease
vaccine is not recommended for persons who are at low risk or
no risk for B. burgdorferi infection.
Travelers
to Areas of High or Moderate Risk
The desirability of vaccination for individuals who travel to
areas of high or moderate risk during Lyme disease transmission
season depends on the anticipated frequency and duration of their
exposure to tick infested habitat, as well as their likelihood
of seeking prompt medical attention if signs or symptoms of Lyme
disease develop. Vaccination should be considered for travelers
to high or moderate risk areas if frequent or prolonged exposure
to tick habitat is anticipated, or if the likelihood of obtaining
prompt medical attention for Lyme disease is low. All travelers
to high or moderate risk areas should practice personal protection
measures as described earlier, and seek prompt diagnosis and
treatment if signs or symptoms of Lyme disease develop.
Vaccination
Use in Children <15 Years
LYMErix™ is licensed for use in individuals 15 to 70 years
of age. Until the safety and immunogenicity of rOspA vaccines
in children has been established, this vaccine should not be
administered to children <15 years of age.
Vaccination
Use in Individuals over 70 Years of Age
Safety and efficacy of LYMErix™ has not been established
in individuals over 70 years of age, and LYMErix™ is licensed
for individuals 15 to 70 years only. The vaccine is not recommended
for individuals over 70 years of age.
Vaccine Use
in Pregnancy
There is no evidence that pregnancy increases the risk of Lyme
disease or its severity. Acute Lyme disease in pregnancy responds
well to antibiotic therapy, and adverse fetal outcomes have not
been reported in pregnant women receiving standard courses of
treatment. Since safety of rOspA vaccines administered during
pregnancy has not been established, vaccination of women who
are known to be pregnant is not recommended.
Vaccine Schedule,
including Spacing and Timing of Administration
Three doses of the vaccine should be administered by intramuscular
injection. The initial dose should be followed by a second dose
1 month later and a third dose 12 months after the first. Vaccine
administration should be timed so that the second dose of the
vaccine (year one), and the third dose (year two) are given several
weeks before the beginning of the B. burgdorferi transmission
season, which usually begins in April.
Boosters
Whether protective immunity will last longer than one year beyond
the month 12 dose is unknown. Data on antibody levels during
a 20-month period after the first injection of LYMErix™
suggest that boosters beyond the month 12 booster may be necessary
(see ÒImmunogencityÓ [ed.section]). Further data
are needed to make recommendations on vaccination with more than
3 doses of rOspA vaccine.
Simultaneous
Administration with other Vaccines
Safety and efficacy of the simultaneous administration of rOspA
vaccine with other vaccines has not been established. If LYMErix™
must be given concurrently with other vaccines, each vaccine
should be administered in a separate syringe at a separate injection
site.
Persons with
Immunodeficiency
Persons with immunodeficiency were excluded from the Phase III
safety and efficacy trial, and there are no data on Lyme disease
vaccine use in this group.
Persons with
previous history of Lyme disease
Vaccination should be considered for persons with a history of
previous uncomplicated Lyme arthritis who are at continued high
risk. Individuals who have treatment resistant Lyme disease should
not be vaccinated because of the association between this condition
and immune reactivity to OspA.
