New Study Results for LYMErix(TM) Demonstrate
Individuals can be Immunized Faster
Additional Pilot Study Finds Vaccine Well-Tolerated and Immunogenic
ADVANCE FOR RELEASE AT 12:00 PM EDT
FRIDAY, NOVEMBER 13 ADVANCE/ DENVER, Nov. 13 PRNewswire
Three doses of LYMErix(TM) ([Lyme Disease Vaccine (Recombinant
OspA)], SmithKline Beecham) when given to adults on an accelerated
dosing schedule of 0, 1, 2 months provide a comparable antibody
response to that obtained in the LYMErix pivotal efficacy trial,
according to a new study presented today at the 36th annual meeting
of the Infectious Diseases Society of America (IDSA) in Denver.
In the pivotal efficacy trial, LYMErix demonstrated vaccine efficacy
rates of 79 percent against definite Lyme disease (characteristic
symptoms with laboratory confirmation) and 100 percent against
asymptomatic infection (no symptoms, but laboratory confirmation
of infection) when given on a 0, 1, 12 month schedule in individuals
15-70 years of age. The study results presented at IDSA today
(0, 1, 2 dosing schedule) are derived from one of a series of
trials evaluating accelerated dosing schedules. Accelerated dosing
would allow people to complete the full immunization series in
a shorter period of time.
"Flexibility of dosing will provide the millions of Americans
at risk for Lyme disease a quicker means of becoming immunized,"
said Vijay Sikand, M.D., adjunct assistant professor of medicine
at Tufts University School of Medicine. " The study results demonstrate
that LYMErix is well-tolerated and produces high antibody titers
when three doses are administered within two months."
Study Demonstrates Shortened Dosing
Schedule Yields Similar Results
In the study presented for the first time at IDSA today, individuals
receiving LYMErix on a 0, 1, 2 month schedule had antibody responses
comparable to those of individuals receiving the vaccine on a
0, 1, 12 month schedule in the efficacy trial. All participants
received two injections of LYMErix at 0, 1 months. Half of the
individuals were then randomized to receive an additional dose
at either month 2 or month 12. Clinical signs and symptoms were
recorded on diary cards for four days after each dose. Blood was
collected one month after the second and third doses. LYMErix
was safe and well-tolerated. Most local and general reactions
reported were mild to moderate in severity and self-limited.
Additional Study Shows LYMErix May Benefit
Results from a separate study presented at IDSA today indicate
that LYMErix, when given on a 0, 1, 2 month schedule, is well-tolerated
and immunogenic for children. This pilot study included 250 children
ages 5-15 in the Czech Republic who received 15 or 30 mg of OspA.
Both vaccine dosages of LYMErix were safe and well-tolerated.
A study is currently under way in the United States to determine
the safety and immunogenicity of 30 mg of LYMErix in children
ages 4 and older.
LYMErix is currently under review by the U.S. Food and Drug Administration
(FDA). An FDA Advisory Committee recently found LYMErix safe and
effective for the prevention of Lyme disease -- one of the fastest-growing
infectious diseases in the United States.
Lyme Disease: A Widespread and Potentially
Debilitating Disease Lyme disease
This is a multi-stage disease caused by infection with a spiral-shaped
bacterium (called a spirochete) known as Borrelia burgdorferi,
which is carried by ticks. Experts believe it may be underreported
by as much as 10 times.
The onset of Lyme disease is commonly associated with a characteristic
skin rash known as erythema migrans (EM), which can vary in size
and location. EM is often accompanied by flu-like symptoms including
headache, fever, fatigue, joint aches, muscle aches and a stiff
neck. When diagnosed early, Lyme disease can usually be successfully
treated with antibiotics without any long- lasting complications.
However, diagnosis can be difficult because symptoms may imitate
other illnesses. After successful treatment of early Lyme disease,
permanent immunity may not develop and reinfection is possible.
If undetected and left untreated, the Lyme bacteria can spread
to other parts of the body months to years following a bite and
manifests itself as late- stage Lyme disease. The bacteria can
affect the joints, tendons, heart or nervous system, potentially
resulting in arthritis, heart abnormalities such as heart block
and myocarditis (inflammation of the muscular walls of heart)
and Bell's palsy (paralysis of one or both sides of the face).
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-- one of the world's leading healthcare companies -- discovers,
develops, manufactures and markets pharmaceuticals, vaccines,
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Wide Web at http://www.sb.com.
Source: SmithKline Beecham