Lyme Vaccine

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January 22, 1999 / 48(02);35-36,43

Notice to Readers Availability of Lyme Disease Vaccine

On December 21, 1998, the Food and Drug Administration (FDA) licensed

LYMErixTM (Kline Beecham Biologicals,

Reixensart, Belgium), * a new vaccine against Lyme disease (LD). This report

summarizes information about this vaccine and

provides epidemiologic information about LD relevant to vaccine use.

Each dose of LYMErixTM contains 30 ug of lipidated recombinant outer surface

protein A (OspA) of Borrelia burgdorferi

sensu stricto, the causative agent of LD in North America, adsorbed onto

aluminum adjuvant (1). It is indicated for use in

persons aged 15-70 years (1). Three doses of the vaccine are administered by

intramuscular injection. The initial dose is

followed by a second dose 1 month later and a third dose 12 months after the

first. Vaccine administration should be timed so

the second dose and the third dose are given several weeks before the

beginning of the B. burgdorferi transmission season (1),

which usually begins in April. In a randomized, double-blind, multicenter

trial involving 10,936 participants living in areas of the

northeastern and upper north central United States where LD is endemic, the

vaccine efficacy in preventing LD was 50% (95%

confidence interval {CI}=14%-71%) after the first two doses and 78% (95%

CI=59%-88%) after three doses (1). Efficacy

against asymptomatic seroconversion was 83% (95% CI=25%-96%) after two doses

and 100% (95% CI=30%-100%) after

three doses (1). The duration of immunity following the three-dose

vaccination series is unknown, and the need for booster

doses has not been determined.

Local reactions at the site of injection were reported by significantly more

vaccine recipients than placebo recipients (1).

Unsolicited reports of myalgia, influenza-like illness, fever, and chills

within 30 days after a dose were significantly more

common among vaccine recipients than placebo recipients, but none of these

were reported by greater than 5% of either group

(1). Reports of arthritis were not significantly different between vaccine

and placebo recipients, but vaccine recipients reported

significantly more transient arthralgia and myalgia following each dose of

vaccine (1).

LD is the most commonly reported vectorborne disease in the United States.

Since the implementation of a standardized

surveillance case definition in 1991, greater than 90% of cases have been

reported from the northeast and north central states

(Figure_1) (2). Persons of all ages are susceptible to infection, but the

highest reported rates of LD occur in children aged less

than 15 years and adults aged 30-59 years. Transmission peaks from April

through July, when the nymphal stages of the tick

vectors of LD, Ixodes scapularis and I. pacificus, are actively seeking

hosts. These ticks are found primarily in leaf litter and

low-lying vegetation in wooded, brushy, or overgrown grassy areas and can

transmit other diseases such as babesiosis and

ehrlichiosis (3,4).

An estimated 85% of persons with symptomatic LD have the characteristic

rash, erythema migrans (5). Untreated infection can

cause arthritis or neurologic symptoms, such as radiculoneuropathy or

encephalopathy. At any stage, the disease can usually be

successfully treated with standard antibiotic regimens.

Strategies to prevent LD include avoiding tick habitats, wearing protective

clothing, using repellents to avoid tick attachment,

promptly removing attached ticks, and employing community measures to reduce

tick abundance (6). Because the vaccine is

less than 100% efficacious and does not provide protection against other

tickborne illnesses, vaccination should not be

considered a substitute for other preventive measures.

LD vaccine should be targeted to persons at risk for exposure to infected

vector ticks. This risk can be assessed by considering

the focal geography of LD and the extent to which a person's activities

place him or her in contact with ticks (2). Vaccination of

persons with frequent or prolonged exposure to ticks in areas endemic for LD

is likely to be an important preventive strategy

(7). For persons with only brief or intermittent exposure to tick habitat in

areas where LD is endemic, the public health benefits

of vaccination, compared with early diagnosis and treatment of LD, are not

clear (7) . Recommendations for use of LD vaccine

are being developed by the Advisory Committee for Immunization Practices.

Reported by: Div of Vector-Borne Infectious Diseases, National Center for

Infectious Diseases, CDC.

References

1.Kline Beecham Biologicals. LYMErixTM product label. Reixensart,

Belgium: Kline Beecham Biologicals,

December 1998.

2.Dennis DT. Epidemiology, ecology, and prevention of Lyme disease. In:

Rahn DW, J, eds. Lyme disease.

Philadelphia: American College of Physicians, 1998;7-34.

3.Spielman A, ML, Levine JF, et al. Ecology of Ixodes

dammini-borne human babesiosis and Lyme disease. Annu

Rev Entomol 1985;30:439-60.

4.Des Vignes F, Fish D. Transmission of the agent of human granulocytic

ehrlichiosis by host-seeking Ixodes scapularis

(Acari:Ixodidae) in southern New York state. J Med Entomol

1997;34:379-82.

5.Nadelman RB, Wormser GP. Lyme borreliosis. Lancet 1998;352:557-65.

6.Piesman J, Gray JS. Lyme disease/Lyme borreliosis. In: Sonenshine DR,

Mather TN, eds. Ecological dynamics of

tick-borne zoonoses. New York: Oxford University Press, 1994:327-50.

7. EB, Dennis DT. Immunization against Lyme disease {Letter}. N Engl

J Med 1998;339:1637.

Use of trade names and commercial sources is for identification only and

does not imply endorsement by CDC or the U.S.

Department of Health and Human Services.