MEDLINE Abstracts: Lyme Disease Vaccine
What's the latest in Lyme disease prevention and vaccination prophylaxis? Find out in this easy-to-navigate collection of recent MEDLINE abstracts compiled by the editors at Medscape Pharmacotherapy.
American Academy of Pediatrics, Committee on Infecious Diseases.
Pediatrics. 2000;105:142-7
Lyme disease is currently the most frequently reported vector-borne illness in the United States, accounting for more than 95% of such cases. The purpose of this report is to provide recommendations for preventing Lyme disease, including the use of Lyme disease vaccine. Individuals can reduce their risk of Lyme disease by avoiding tick-infested habitats when in endemic areas. If exposure to tick-infested habitats cannot be avoided, individuals may reduce their risk of infection by using repellents, wearing protective clothing, and regularly checking for and removing attached ticks. Morbidity from Lyme disease can be reduced significantly by detecting and treating the infection in its early stages; early and appropriate treatment almost always results in a prompt and uncomplicated cure. A Lyme disease vaccine (LYMErix, SmithKline Beecham, Collegeville, PA) was licensed by the US Food and Drug Administration on December 21, 1998, for persons 15 to 70 years of age. This vaccine seems to be safe and effective, but whether its use is cost-effective has yet to be clearly established. Use of this vaccine causes false-positive enzyme immunoassay results for Lyme disease. Lyme disease can be diagnosed in vaccinated persons by immunoblot testing. Decisions about the use of this vaccine should be based on an assessment of a person's risk as determined by activities and behaviors relating to tick exposure in endemic areas. This vaccine should be considered an adjunct to, not a replacement for, the practice of personal protective measures against tick exposure and the early diagnosis and treatment of Lyme disease.
Lutwick LI, Abramson JM
Pediatr Clin North Am. 2000;47:465-79, viii
This article highlights some of the exciting new developments in pediatric immunization. Starting with the newly licensed Lyme disease vaccine, which is not yet approved for children younger than 15 years of age, the article discusses potential vaccines for severe allergy and cocaine abuse and stresses some of the new techniques in needleless vaccination, including the edible plant technology.
Shadick NA, Liang MH, Phillips CB, et al
Arch Intern Med. 2001;161:554-561
Background: Vaccination against Lyme disease appears to be safe and effective; however, the cost per quality-adjusted life-year (QALY) gained with vaccination is unknown.
Methods: We developed a decision-analytic model to evaluate the cost-effectiveness of vaccination compared with no vaccination in individuals living in endemic areas of Lyme disease. Our analysis encompassed a 10-year time horizon including a 2-year vaccination schedule with an additional year of vaccine effectiveness. The costs and probabilities of vaccination risk, compliance and efficacy, and Lyme disease clinical sequelae and treatment were estimated from the literature. Health-related quality-of-life weights of the various clinical sequelae of Lyme disease infection were obtained from a sample of 105 residents from Nantucket Island, Massachusetts.
Results: Vaccinating 10 000 residents living in endemic areas with a probability of Lyme disease per season of 0.01 averted 202 cases of Lyme disease during a 10-year period. The additional cost per QALY gained compared with no vaccination was $62 300. Vaccination cost $12 600/QALY gained for endemic areas with an attack rate of 2.5% per season, and $145 200/QALY gained for an attack rate of 0.5%. Vaccinating individuals over an accelerated 2-month vaccination schedule improved the cost-effectiveness to $53 700/QALY gained. If a yearly booster shot is required for persisting efficacy, the marginal cost-effectiveness ratio increases to $72 700/QALY. The cost-effectiveness of vaccination was most sensitive to the Lyme disease treatment efficacy and assumptions about the persistence of vaccination effect.
Conclusion: Vaccination against Lyme disease appears only to be economically attractive for individuals who have a seasonal probability of Borrelia burgdorferi infection of greater than 1%.
Meltzer MI, Dennis DT, Orloski KA
Emerg Infect Dis. 1999;5:321-8
To determine the cost effectiveness of vaccinating against Lyme disease, we used a decision tree to examine the impact on society of six key components. The main measure of outcome was the cost per case averted. Assuming a 0.80 probability of diagnosing and treating early Lyme disease, a 0.005 probability of contracting Lyme disease, and a vaccination cost of $50 per year, the mean cost of vaccination per case averted was $4,466. When we increased the probability of contracting Lyme disease to 0.03 and the cost of vaccination to $100 per year, the mean net savings per case averted was $3,377. Since few communities have average annual incidences of Lyme disease >0. 005, economic benefits will be greatest when vaccination is used on the basis of individual risk, specifically, in persons whose probability of contracting Lyme disease is >0.01.
Wormser GP
Infect Dis Clin North Am. 1999;13:135-48, vii
Recombinant outer surface protein A (OspA) of Borrelia burgdorferi is a highly protective immunogen for prevention of Lyme disease in experimental animals. Humoral immunity is sufficient for protection. The principal mechanism of action is prevention of transmission of the spirochete from tick to host. A recombinant OspA vaccine has been licensed for use in dogs. The recent licensure of an OspA vaccine for humans resulted from a critical analysis of recently completed efficacy studies.
Hayney MS, Grunske MM, Boh LE
Ann Pharmacother. 1999;33:723-9
Objective: To provide a comprehensive review of the epidemiology, diagnosis, and prevention of Lyme disease with a focus on the Lyme disease vaccine.
Data Source: A computerized search of MEDLINE (January 1996-December 1998) was used to identify articles regarding Lyme disease, Borrelia burgdorferi, epidemiology, prevention, and vaccine.
Data Synthesis: Lyme disease is a condition caused by infection with B. burgdorferi. The organism is carried by certain species of Ixodes ticks and is the most common tick-borne disease in the US. In patients with clinical manifestations of Lyme disease, various pharmacotherapeutic approaches have proven effective in treatment of the clinical features. Prevention strategies exist; however, their application is sometimes difficult. A vaccine for the prevention of Lyme disease is available, and another is being considered for approval. The recombinant outer surface protein A (OspA) vaccines to prevent Lyme disease are immunogenic and have an acceptable adverse effect profile. These vaccines are highly efficacious for the prevention of Lyme disease.
Conclusions: Lyme disease is the most common tick-borne disease in the US. The infection, caused by B. burgdorferi, results in dermatologic, neurologic, cardiovascular, and musculoskeletal manifestations. Until recently, tick bite prevention strategies were the only means of decreasing the risk of acquiring the infection. The OspA vaccines are efficacious for the prevention of infection. Although universal immunization with these vaccines is unlikely, the availability of effective vaccines represents an important tool for the prevention of Lyme disease in endemic regions of the US.
Onrust SV, Goa KL
Drugs. 2000;59:281-99
Lyme disease is a potentially serious infection which is caused by the spirochaete Borrelia burgdorferi and is endemic in certain areas of North America, Europe and Asia. Lyme disease vaccine (LYMErix) is an adjuvanted formulation of the outer surface protein A (OspA) of the causative spirochaete. It acts by inducing high titres of anti-OspA antibodies (anti-OspA), which must be present in vaccinated individuals before exposure to B. burgdorferi to provide protection against Lyme disease. Lyme disease vaccine efficacy against Lyme disease was 80% for definite and asymptomatic cases and 76% for definite cases at year 2 using the recommended dosage regimen [30 microg at months 0, 1 and 12 (0, 1, 12 schedule)] in a randomised, double-blind, multicentre trial in 10,936 enrolled adult volunteers who resided in areas of the US endemic for Lyme disease. On the basis of an anti-OspA correlate of protection, Lyme disease vaccine 30 microg was equally effective when administered by a shorter schedule (0, 1, 6 schedule); > or = 90% of adult volunteers developed protective anti-OspA titres with this or the 0, 1, 12 schedule. Although published data are fewer, a 0, 1, 2 schedule has also shown promise in adults. In addition, virtually all children (aged 2 to 15 years) given Lyme disease vaccine 30 microg developed protective anti-OspA titres, but published data are also limited and results of a large paediatric trial are awaited with interest. Long term protection against Lyme disease appears to be possible with Lyme disease vaccine. Although anti-OspA titres decline rapidly after completion of the recommended schedule, booster doses of 30 microg of the vaccine induced protective anti-OspA titres in > or = 96% of adult volunteers when administered 12 and/or 24 months later. Lyme disease vaccine 30 microg is well tolerated: most vaccination-related adverse events were transient and mild or moderate in severity in clinical trials. The most common spontaneously reported adverse event was pain at the injection site in 24% of vaccine recipients (vs 7.6% of the placebo group). The incidence of spontaneously reported, early nonspecific systemic adverse events was <4% but was higher with the vaccine than with placebo for some events (e.g. myalgias, fever and chills but not arthralgia). There appeared to be no association between the vaccine and the incidence of arthritis or any late systemic adverse events. The tolerability profile of Lyme disease vaccine did not appear to vary with the schedule of administration, nor to differ between adults and children. Conclusions: Lyme disease vaccine, an adjuvanted formulation of OspA, protects most adults against Lyme disease when administered by the recommended 0, 1, 12 schedule before disease exposure, and is well tolerated. The optimal schedule(s) of administration, duration of protection against Lyme disease, long term tolerability in adults and potential role in children are not fully defined for this vaccine. Lyme disease vaccine is indicated in North America for active immunisation of adults at moderate to high risk of contracting Lyme disease.
Poland GA, Jacobson RM
Vaccine. 2001;19:2303-8
Lyme disease is a potentially serious and debilitating infection caused by Borrelia burgdorferi that is endemic in North America, Europe, and Asia. Personal protective and environmental measures have not significantly impacted its increasing incidence. An adjuvanted recombinant vaccine (LYMErix) has been approved in the United States for the prevention of Lyme disease in adults, and has demonstrated both safety and efficacy. A clinical trial of over 10000 adults showed 76% efficacy following the third dose of a 0, 1, 12 schedule. Accelerated schedules demonstrate equivalent levels of protective antibody. Up to 100% of children 2-14 years of age achieve seroprotective levels of antibody. Booster doses induced protective levels of antibody in more than 96% of recipients when administered at months 12 and 24. Only mild or moderate, transient vaccine-associated adverse events have been reported after immunization. The vaccine is a safe and effective method of preventing Lyme disease.
Hu LT, Klempner MS
Adv Intern Med. 2001;46:247-75
With our better understanding of Lyme disease, we now know it is not the "great imitator" of disease it once was thought to be. Limited, identifiable syndromes can be related to Lyme disease. Most of the disease's manifestations resolve without treatment. Treatment with standard antibiotics is very effective at preventing the development of long-term sequelae. The Lyme disease vaccine is safe and effective at preventing transmission of Lyme disease. Future improvements in the care of patients with Lyme disease should focus on identifying the etiology and most effective therapies for patients with posttreatment chronic Lyme disease syndrome, determining the safety and efficacy of vaccination in children, and developing second generation vaccines with improved efficacy and dosing schedules, possibly through the addition of antigens expressed in the human host.
What's the latest in Lyme disease prevention and vaccination prophylaxis? Find out in this easy-to-navigate collection of recent MEDLINE abstracts compiled by the editors at Medscape Pharmacotherapy.
American Academy of Pediatrics, Committee on Infecious Diseases.
Pediatrics. 2000;105:142-7
Lyme disease is currently the most frequently reported vector-borne illness in the United States, accounting for more than 95% of such cases. The purpose of this report is to provide recommendations for preventing Lyme disease, including the use of Lyme disease vaccine. Individuals can reduce their risk of Lyme disease by avoiding tick-infested habitats when in endemic areas. If exposure to tick-infested habitats cannot be avoided, individuals may reduce their risk of infection by using repellents, wearing protective clothing, and regularly checking for and removing attached ticks. Morbidity from Lyme disease can be reduced significantly by detecting and treating the infection in its early stages; early and appropriate treatment almost always results in a prompt and uncomplicated cure. A Lyme disease vaccine (LYMErix, SmithKline Beecham, Collegeville, PA) was licensed by the US Food and Drug Administration on December 21, 1998, for persons 15 to 70 years of age. This vaccine seems to be safe and effective, but whether its use is cost-effective has yet to be clearly established. Use of this vaccine causes false-positive enzyme immunoassay results for Lyme disease. Lyme disease can be diagnosed in vaccinated persons by immunoblot testing. Decisions about the use of this vaccine should be based on an assessment of a person's risk as determined by activities and behaviors relating to tick exposure in endemic areas. This vaccine should be considered an adjunct to, not a replacement for, the practice of personal protective measures against tick exposure and the early diagnosis and treatment of Lyme disease.
Lutwick LI, Abramson JM
Pediatr Clin North Am. 2000;47:465-79, viii
This article highlights some of the exciting new developments in pediatric immunization. Starting with the newly licensed Lyme disease vaccine, which is not yet approved for children younger than 15 years of age, the article discusses potential vaccines for severe allergy and cocaine abuse and stresses some of the new techniques in needleless vaccination, including the edible plant technology.
Shadick NA, Liang MH, Phillips CB, et al
Arch Intern Med. 2001;161:554-561
Background: Vaccination against Lyme disease appears to be safe and effective; however, the cost per quality-adjusted life-year (QALY) gained with vaccination is unknown.
Methods: We developed a decision-analytic model to evaluate the cost-effectiveness of vaccination compared with no vaccination in individuals living in endemic areas of Lyme disease. Our analysis encompassed a 10-year time horizon including a 2-year vaccination schedule with an additional year of vaccine effectiveness. The costs and probabilities of vaccination risk, compliance and efficacy, and Lyme disease clinical sequelae and treatment were estimated from the literature. Health-related quality-of-life weights of the various clinical sequelae of Lyme disease infection were obtained from a sample of 105 residents from Nantucket Island, Massachusetts.
Results: Vaccinating 10 000 residents living in endemic areas with a probability of Lyme disease per season of 0.01 averted 202 cases of Lyme disease during a 10-year period. The additional cost per QALY gained compared with no vaccination was $62 300. Vaccination cost $12 600/QALY gained for endemic areas with an attack rate of 2.5% per season, and $145 200/QALY gained for an attack rate of 0.5%. Vaccinating individuals over an accelerated 2-month vaccination schedule improved the cost-effectiveness to $53 700/QALY gained. If a yearly booster shot is required for persisting efficacy, the marginal cost-effectiveness ratio increases to $72 700/QALY. The cost-effectiveness of vaccination was most sensitive to the Lyme disease treatment efficacy and assumptions about the persistence of vaccination effect.
Conclusion: Vaccination against Lyme disease appears only to be economically attractive for individuals who have a seasonal probability of Borrelia burgdorferi infection of greater than 1%.
Meltzer MI, Dennis DT, Orloski KA
Emerg Infect Dis. 1999;5:321-8
To determine the cost effectiveness of vaccinating against Lyme disease, we used a decision tree to examine the impact on society of six key components. The main measure of outcome was the cost per case averted. Assuming a 0.80 probability of diagnosing and treating early Lyme disease, a 0.005 probability of contracting Lyme disease, and a vaccination cost of $50 per year, the mean cost of vaccination per case averted was $4,466. When we increased the probability of contracting Lyme disease to 0.03 and the cost of vaccination to $100 per year, the mean net savings per case averted was $3,377. Since few communities have average annual incidences of Lyme disease >0. 005, economic benefits will be greatest when vaccination is used on the basis of individual risk, specifically, in persons whose probability of contracting Lyme disease is >0.01.
Wormser GP
Infect Dis Clin North Am. 1999;13:135-48, vii
Recombinant outer surface protein A (OspA) of Borrelia burgdorferi is a highly protective immunogen for prevention of Lyme disease in experimental animals. Humoral immunity is sufficient for protection. The principal mechanism of action is prevention of transmission of the spirochete from tick to host. A recombinant OspA vaccine has been licensed for use in dogs. The recent licensure of an OspA vaccine for humans resulted from a critical analysis of recently completed efficacy studies.
Hayney MS, Grunske MM, Boh LE
Ann Pharmacother. 1999;33:723-9
Objective: To provide a comprehensive review of the epidemiology, diagnosis, and prevention of Lyme disease with a focus on the Lyme disease vaccine.
Data Source: A computerized search of MEDLINE (January 1996-December 1998) was used to identify articles regarding Lyme disease, Borrelia burgdorferi, epidemiology, prevention, and vaccine.
Data Synthesis: Lyme disease is a condition caused by infection with B. burgdorferi. The organism is carried by certain species of Ixodes ticks and is the most common tick-borne disease in the US. In patients with clinical manifestations of Lyme disease, various pharmacotherapeutic approaches have proven effective in treatment of the clinical features. Prevention strategies exist; however, their application is sometimes difficult. A vaccine for the prevention of Lyme disease is available, and another is being considered for approval. The recombinant outer surface protein A (OspA) vaccines to prevent Lyme disease are immunogenic and have an acceptable adverse effect profile. These vaccines are highly efficacious for the prevention of Lyme disease.
Conclusions: Lyme disease is the most common tick-borne disease in the US. The infection, caused by B. burgdorferi, results in dermatologic, neurologic, cardiovascular, and musculoskeletal manifestations. Until recently, tick bite prevention strategies were the only means of decreasing the risk of acquiring the infection. The OspA vaccines are efficacious for the prevention of infection. Although universal immunization with these vaccines is unlikely, the availability of effective vaccines represents an important tool for the prevention of Lyme disease in endemic regions of the US.
Onrust SV, Goa KL
Drugs. 2000;59:281-99
Lyme disease is a potentially serious infection which is caused by the spirochaete Borrelia burgdorferi and is endemic in certain areas of North America, Europe and Asia. Lyme disease vaccine (LYMErix) is an adjuvanted formulation of the outer surface protein A (OspA) of the causative spirochaete. It acts by inducing high titres of anti-OspA antibodies (anti-OspA), which must be present in vaccinated individuals before exposure to B. burgdorferi to provide protection against Lyme disease. Lyme disease vaccine efficacy against Lyme disease was 80% for definite and asymptomatic cases and 76% for definite cases at year 2 using the recommended dosage regimen [30 microg at months 0, 1 and 12 (0, 1, 12 schedule)] in a randomised, double-blind, multicentre trial in 10,936 enrolled adult volunteers who resided in areas of the US endemic for Lyme disease. On the basis of an anti-OspA correlate of protection, Lyme disease vaccine 30 microg was equally effective when administered by a shorter schedule (0, 1, 6 schedule); > or = 90% of adult volunteers developed protective anti-OspA titres with this or the 0, 1, 12 schedule. Although published data are fewer, a 0, 1, 2 schedule has also shown promise in adults. In addition, virtually all children (aged 2 to 15 years) given Lyme disease vaccine 30 microg developed protective anti-OspA titres, but published data are also limited and results of a large paediatric trial are awaited with interest. Long term protection against Lyme disease appears to be possible with Lyme disease vaccine. Although anti-OspA titres decline rapidly after completion of the recommended schedule, booster doses of 30 microg of the vaccine induced protective anti-OspA titres in > or = 96% of adult volunteers when administered 12 and/or 24 months later. Lyme disease vaccine 30 microg is well tolerated: most vaccination-related adverse events were transient and mild or moderate in severity in clinical trials. The most common spontaneously reported adverse event was pain at the injection site in 24% of vaccine recipients (vs 7.6% of the placebo group). The incidence of spontaneously reported, early nonspecific systemic adverse events was <4% but was higher with the vaccine than with placebo for some events (e.g. myalgias, fever and chills but not arthralgia). There appeared to be no association between the vaccine and the incidence of arthritis or any late systemic adverse events. The tolerability profile of Lyme disease vaccine did not appear to vary with the schedule of administration, nor to differ between adults and children. Conclusions: Lyme disease vaccine, an adjuvanted formulation of OspA, protects most adults against Lyme disease when administered by the recommended 0, 1, 12 schedule before disease exposure, and is well tolerated. The optimal schedule(s) of administration, duration of protection against Lyme disease, long term tolerability in adults and potential role in children are not fully defined for this vaccine. Lyme disease vaccine is indicated in North America for active immunisation of adults at moderate to high risk of contracting Lyme disease.
Poland GA, Jacobson RM
Vaccine. 2001;19:2303-8
Lyme disease is a potentially serious and debilitating infection caused by Borrelia burgdorferi that is endemic in North America, Europe, and Asia. Personal protective and environmental measures have not significantly impacted its increasing incidence. An adjuvanted recombinant vaccine (LYMErix) has been approved in the United States for the prevention of Lyme disease in adults, and has demonstrated both safety and efficacy. A clinical trial of over 10000 adults showed 76% efficacy following the third dose of a 0, 1, 12 schedule. Accelerated schedules demonstrate equivalent levels of protective antibody. Up to 100% of children 2-14 years of age achieve seroprotective levels of antibody. Booster doses induced protective levels of antibody in more than 96% of recipients when administered at months 12 and 24. Only mild or moderate, transient vaccine-associated adverse events have been reported after immunization. The vaccine is a safe and effective method of preventing Lyme disease.
Hu LT, Klempner MS
Adv Intern Med. 2001;46:247-75
With our better understanding of Lyme disease, we now know it is not the "great imitator" of disease it once was thought to be. Limited, identifiable syndromes can be related to Lyme disease. Most of the disease's manifestations resolve without treatment. Treatment with standard antibiotics is very effective at preventing the development of long-term sequelae. The Lyme disease vaccine is safe and effective at preventing transmission of Lyme disease. Future improvements in the care of patients with Lyme disease should focus on identifying the etiology and most effective therapies for patients with posttreatment chronic Lyme disease syndrome, determining the safety and efficacy of vaccination in children, and developing second generation vaccines with improved efficacy and dosing schedules, possibly through the addition of antigens expressed in the human host.
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