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Data Show LYMErix® Is Well Tolerated in Children and Is Effective Against

Asymptomatic Infection in Adults

Additional Study Presents Long-Term Safety Data in Adults

PHILADELPHIA, Nov. 19 /PRNewswire/ -- A study with LYMErix® [Lyme Disease

Vaccine (Recombinant OspA)], manufactured by Kline Beecham Biologicals,

presented at the Infectious Diseases Society of America (IDSA) meeting this

week in Philadelphia, showed that after three doses, LYMErix® reduced the

risk of asymptomatic Lyme disease infection by 100 percent.

LYMErix®, the world's first vaccine for the prevention of Lyme disease, was

approved by the U.S. Food and Drug Administration (FDA) in December 1998 for

people 15 through 70 years of age. To date, over a million doses have been

distributed with no unusual pattern of adverse events reported. One of the

fastest-growing vector-borne diseases in the United States, Lyme disease is a

potentially serious multi-stage bacterial infection with a wide range of

symptoms -- from a characteristic skin rash and flu-like symptoms to

arthritis and heart abnormalities. Lyme disease accounts for 95 percent of

all vector-borne diseases, with cases reported in 48 states.

" For every four cases of Lyme disease with the characteristic skin rash,

there is one case of asymptomatic infection. Asymptomatic infection is

significant because it may be the source for onset of late-stage Lyme

disease, which is more difficult to diagnose and more difficult to treat, "

said Vijay K. Sikand, M.D., F.A.A.F.P., adjunct assistant professor of

medicine at Tufts University School of Medicine and lead author of the study.

" The findings presented at IDSA confirm that LYMErix® prevents

asymptomatic infection, thus possibly avoiding the risk of late-stage

disease. "

LYMErix® [Lyme Disease Vaccine (Recombinant OspA)] Protected Against All

Cases of Asymptomatic Infection

In the data presented at IDSA, LYMErix®, after three doses, reduced the

risk of asymptomatic Lyme disease infection among vaccinated individuals by

100 percent. After two doses, the risk of asymptomatic infection was reduced

by 83 percent. In addition, evidence was presented suggesting that

asymptomatic infection can cause late-stage symptoms.

Study Results Show LYMErix® Is Well Tolerated in Children

Results from a pilot study published for the first time this month in The

Journal of Pediatrics indicate that LYMErix®, when given on a 0,1,2-month

schedule, is well tolerated and highly immunogenic in children 5-15 years of

age. This study included 250 children who received either 15 or 30

micrograms of LYMErix®. Both vaccine doses of LYMErix® were well

tolerated and there were no vaccine-related serious adverse events.

A large-scale immunogenicity and safety study of LYMErix®, with 30

micrograms administered at 0,1,12 months, conducted in the United States in

4000 children ages 4-18 has recently been unblinded.

" The pilot pediatric study demonstrates the safety and immunogenicity of the

Lyme vaccine in children, " said Henry Feder, Jr., M.D., professor of

pediatrics and family medicine at Connecticut Children's Medical Center and

the University of Connecticut Health Center and lead author of the study.

" We expect the large U.S. pediatric trial of the Lyme vaccine will confirm

the findings of the pilot study. "

Study Supports Long-Term Safety in Adults

In two prospective, open label studies conducted to evaluate the safety and

immunogenicity of booster doses of LYMErix®, fourth and fifth doses of

LYMErix® were given after either a 0,1,2 or 0,1,12 month primary series.

In the two studies combined, approximately 800 subjects received a fourth

booster dose of LYMErix® [Lyme Disease Vaccine (Recombinant OspA)] and 230

of these subjects received a fifth dose of vaccine. Four years of follow-up

data after the first dose of LYMErix®, which was followed with completion

of the three-dose primary series and the boosters, showed that the vaccine

was well tolerated and no unusual pattern of adverse events was noted.

" These data, presented at IDSA, underscore the overall safety and efficacy of

LYMErix®, " said Dennis Parenti, M.D., Director, Clinical Research and

Development and Medical Affairs, Kline Beecham. " The studies add

further evidence that LYMErix® offers a significant advance in Lyme disease

prevention and should be the first line of defense in prevention of the

potentially debilitating effects of Lyme disease. "

LYMErix® [Lyme Disease Vaccine (Recombinant OspA)]

LYMErix® is indicated for people 15 through 70. As with any vaccine,

LYMErix® may not protect 100 percent of individuals. After three doses,

LYMErix® reduced the risk of definite Lyme disease by 78 percent and

reduced the risk of asymptomatic infection by 100 percent (after two doses,

LYMErix® reduced the risk by 50 percent and 83 percent, respectively).

LYMErix® is administered in three doses on a 0,1,12-month schedule. To

ensure optimal protection, it is important that an individual receives all

three doses. LYMErix® may be associated with local injection-site reactions

including redness and swelling, flu-like symptoms, joint and muscle pain. To

date, over a million doses of LYMErix® have been distributed with no

unusual pattern of adverse events reported.

A Leader in Healthcare

Kline Beecham -- one of the world's leading healthcare companies --

discovers, develops, manufactures and markets pharmaceuticals, vaccines,

over-the-counter medicines and health-related consumer products. For company

information, visit Kline Beecham on the World Wide Web at

http://www.sb.com

SOURCE Kline Beecham

CO: Kline Beecham; Kline Beecham Biologicals

ST: Pennsylvania, Belgium

IN: MTC BIO

SU: PDT

11/19/1999 10:01 EST http://www.prnewswire.com

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