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abcd AUGUST | 2010 Vaccine Technical Review BOEHRINGER INGELHEIM VETMEDICA, INC. About Dr. Levy KEY POINTS Steven A. Levy, VMD is a 1977 graduate of the University of Pennsylvania, School of Veterinary Medicine. He worked in small animal veterinary practice in Durham, Connecticut, and was veterinary surgeon for the Connecticut State Police Canine Unit. Currently, he is president of Veterinary Clinical and Consulting Services. A nationally recognized authority on ticks and tick-borne diseases, Dr. Levy has published many peer-reviewed papers and lectured widely in the U.S. and internationally. He is a recipient of the AVMA’s Practitioner Research Award and the AAHA’s Outstanding Regional Practitioner Award. Test, Treat and Vaccinate Protocol Preventing clinical Lyme disease in Lyme-positive (infected) dogs BY STEVEN A. LEVY, VMD The first canine Lyme vaccine was introduced in 1990 and demonstrated safety and efficacy in preventing Lyme disease. The first canine Lyme vaccine was introduced to the market in June 1990 at a time when infection rates with Borrelia burgdorferi were up to 50 percent1 or more in Lyme-endemic areas. Vast numbers of B. burgdorferi -infected dogs were safely immunized and efficacy in prevention of episodes of clinical Lyme disease was demonstrated. Antibiotic therapy has been demonstrated effective in resolving clinical signs in Lyme-positive dogs. Dogs presenting to veterinarians for treatment of canine Lyme arthritis may be successfully treated in 75 2,3 to 85 percent of cases with antibiotics like amoxicillin or doxycycline. Antibiotic therapy has been demonstrated to kill spirochetes4 and it is likely this is the mechanism associated with resolution of clinical signs. Incidence of clinical disease in dogs appeared to decrease between 1992 and 1993 due to prevention of new infections. In 1992, data were published1 indicating five percent of Lyme-positive dogs developed clinical signs of Lyme disease each year they were observed. While Lyme arthritis could often be successfully treated, Lyme nephritis nearly always resulted in the death or euthanasia of the pet.2,5 Incidence of episodes of Lyme disease in Lyme-positive dogs receiving Duramune® Lyme™ immunization in a 1993 JAVMA study was two percent.6 It may be hypothesized that this decrease in incidence was due to prevention of new infection or some unknown in vivo mechanism involving immune surveillance for spirochetes in the infected dog. The SNAP 3Dx patientside rapid test for Lyme infection became available in 2001. In 2001, a patient-side rapid test (SNAP 3Dx) became available for the determination of a dog’s B. burgdorferi infection status.7,8 By 2001, I had been treating acutely ill dogs with antibiotics for more than 14 years and immunizing clinically normal dogs (of which 50 percent or more were unidentified asymptomatic Lyme-positive) for 11 years. Suddenly, I was able to immediately determine the infection status of a healthy dog presented for Footnotes Levy SA, Magnarelli LA. Relationship between development of antibodies to Borrelia burgdorferi in dogs and the subsequent development of limb/joint borreliosis. JAVMA. 1992;200(3):344-347. 1 Levy SA, Dreesen DW. Lyme borreliosis in dogs. Canine Pract. 1992;17(2):5-13. 2 Levy SA. Unpublished clinical observations. 3 Philipp MW, Bowers LC, Fawcett PT, et al. Antibody response to IR6, a conserved immunodominant region of the VlsE lipoprotein, wanes rapidly after antibiotic treatment of Borrelia burgdorferi infection in experimental animals and humans. L Infect Dis. 2001;184:870-878. 4 Levy SA, Dombach DM, Barthold SW, et al. Canine Lyme borreliosis. Comp CE. 1993;15(6):833-846. 5 Levy SA, Lissman BW, Ficke CM. Performance of a Borrelia burgdorferi bacterin in borreliosis-endemic areas. JAVMA. 1993;202(11):1834-1838. 6 O’Connor TP, Esty KJ, Hanscom JL, et al. Dogs vaccinated with common Lyme disease vaccines do not respond to IR6, the conserved immunodominant region of the VlsE surface protein of Borrelia burgdorferi. Clin Diag Lab Immunol. 2004;11(3):458-462. 7 Levy SA, O’Connor TP, Hanscom JL, et al. Utility of an in-office C6 ELISA test kit for determination of infection status of dogs naturally exposed to Borrelia burgdorferi. Vet Ther. 2002;3(3):308-315. 8 continued on page 3 4 ©2010 Boehringer Ingelheim Vetmedica, Inc. All products are trademarks or registered trademarks of their manufacturers. CAN0710030 1 TEST, TREAT, VACCINATE PROTOCOL Therapeutic Doses of Antibiotics Asymptomatic Dogs TEST TREAT RECHECK VACCINATE PENICILLIN AMOXICILLIN DOXYCYCLINE Asymptomatic SNAP negative None N/A Give annual booster or two-dose series of Lyme vaccine if dog has never been immunized or is previously immunized with OspA-only recombinant vaccine. Injectable — doses vary according to formulation. See product label. Administer on day one. 5 – 10 mg/# p.o. bid. 4 mg/# p.o. bid (must be given with food). Asymptomatic SNAP positive Single infection with B. burgdorferi with either amoxicillin or doxycycline N/A Give annual booster or two-dose series of Lyme vaccine if dog has never been immunized or is previously immunized with OspA-only vaccine. Coinfection with B. burgdorferi and Anaplasma with doxycycline. Test, Treat and Vaccinate Protocol Symptomatic Dogs TEST TREAT RECHECK VACCINATE Symptomatic SNAP positive Penicillin by injection followed by oral amoxicillin. Two weeks after start of therapy. If signs have resolved in B. burgdorferi positive dog: (Acute Lyme patients will not eat and cannot start on oral doxycycline until signs begin to resolve and they are eating well.) • Continue amoxicillin for another two weeks (28 days total). • Give first dose of Lyme vaccine on day of recheck. • Give second dose of Lyme vaccine on day 28 (last day of antibiotic therapy). If signs have resolved in B. burgdorferi and Anaplasma coinfected dog: 2 • Begin 28 day course of therapy with doxycycline. (Discontinue amoxicillin.) • Give first dose of Lyme vaccine on day of recheck. • Give second dose of Lyme vaccine between day 14 and day 28 of doxycycline therapy. (continued from page 1) KEY POINTS annual immunizations and surveillance testing. The notion of combining antibiotic therapy to kill spirochetes and immunization to prevent new infection in asymptomatic Lyme-positive dogs became a working protocol and the basis of a clinical study. The Test, Treat, Vaccinate (TTV) Protocol simply identifies asymptomatic Lyme-positive dogs that are then placed on 28 days of antibiotic therapy and immunized during the period of antibiotic treatment. (See TABLE .) The TTV Protocol involves treating infected dogs even in the absence of clinical signs, and then vaccinating. Between 2001 and 2005, I followed 200 dogs on this protocol. Each dog was observed for signs of Lyme disease. During varying durations in this period, none of the dogs developed clinical episodes of canine Lyme disease. When contrasted with the five percent incidence in known infected dogs that receive no intervention and the two percent incidence in infected dogs receiving only immunization, the combination of antibiotic therapy and immunization was found to be highly effective to eliminate clinical episodes. The TTV Protocol was found to be highly effective in preventing clinical signs in infected dogs. Ideally, all dogs at risk for infection with B. burgdorferi should be immunized before they are bitten by infected ticks. The reality is many dogs will present to veterinarians for initial Lyme immunization with asymptomatic infections. The TTV Protocol provides a safe and effective way to reduce clinical episodes in Lyme-infected dogs. Though all at-risk dogs should be vaccinated to prevent infection, the TTV Protocol can be safely used to prevent clinical signs in infected dogs. 3 TEST, TREAT, VACCINATE PROTOCOL Therapeutic Doses of Antibiotics Asymptomatic Dogs TEST TREAT RECHECK VACCINATE PENICILLIN AMOXICILLIN DOXYCYCLINE Asymptomatic SNAP negative None N/A Give annual booster or two-dose series of Lyme vaccine if dog has never been immunized or is previously immunized with OspA-only recombinant vaccine. Injectable — doses vary according to formulation. See product label. Administer on day one. 5 – 10 mg/# p.o. bid. 4 mg/# p.o. bid (must be given with food). Asymptomatic SNAP positive Single infection with B. burgdorferi with either amoxicillin or doxycycline N/A Give annual booster or two-dose series of Lyme vaccine if dog has never been immunized or is previously immunized with OspA-only vaccine. Coinfection with B. burgdorferi and Anaplasma with doxycycline. Test, Treat and Vaccinate Protocol Symptomatic Dogs TEST TREAT RECHECK VACCINATE Symptomatic SNAP positive Penicillin by injection followed by oral amoxicillin. Two weeks after start of therapy. If signs have resolved in B. burgdorferi positive dog: (Acute Lyme patients will not eat and cannot start on oral doxycycline until signs begin to resolve and they are eating well.) • Continue amoxicillin for another two weeks (28 days total). • Give first dose of Lyme vaccine on day of recheck. • Give second dose of Lyme vaccine on day 28 (last day of antibiotic therapy). If signs have resolved in B. burgdorferi and Anaplasma coinfected dog: 2 • Begin 28 day course of therapy with doxycycline. (Discontinue amoxicillin.) • Give first dose of Lyme vaccine on day of recheck. • Give second dose of Lyme vaccine between day 14 and day 28 of doxycycline therapy. (continued from page 1) KEY POINTS annual immunizations and surveillance testing. The notion of combining antibiotic therapy to kill spirochetes and immunization to prevent new infection in asymptomatic Lyme-positive dogs became a working protocol and the basis of a clinical study. The Test, Treat, Vaccinate (TTV) Protocol simply identifies asymptomatic Lyme-positive dogs that are then placed on 28 days of antibiotic therapy and immunized during the period of antibiotic treatment. (See TABLE .) The TTV Protocol involves treating infected dogs even in the absence of clinical signs, and then vaccinating. Between 2001 and 2005, I followed 200 dogs on this protocol. Each dog was observed for signs of Lyme disease. During varying durations in this period, none of the dogs developed clinical episodes of canine Lyme disease. When contrasted with the five percent incidence in known infected dogs that receive no intervention and the two percent incidence in infected dogs receiving only immunization, the combination of antibiotic therapy and immunization was found to be highly effective to eliminate clinical episodes. The TTV Protocol was found to be highly effective in preventing clinical signs in infected dogs. Ideally, all dogs at risk for infection with B. burgdorferi should be immunized before they are bitten by infected ticks. The reality is many dogs will present to veterinarians for initial Lyme immunization with asymptomatic infections. The TTV Protocol provides a safe and effective way to reduce clinical episodes in Lyme-infected dogs. Though all at-risk dogs should be vaccinated to prevent infection, the TTV Protocol can be safely used to prevent clinical signs in infected dogs. 3 abcd AUGUST | 2010 Vaccine Technical Review BOEHRINGER INGELHEIM VETMEDICA, INC. About Dr. Levy KEY POINTS Steven A. Levy, VMD is a 1977 graduate of the University of Pennsylvania, School of Veterinary Medicine. He worked in small animal veterinary practice in Durham, Connecticut, and was veterinary surgeon for the Connecticut State Police Canine Unit. Currently, he is president of Veterinary Clinical and Consulting Services. A nationally recognized authority on ticks and tick-borne diseases, Dr. Levy has published many peer-reviewed papers and lectured widely in the U.S. and internationally. He is a recipient of the AVMA’s Practitioner Research Award and the AAHA’s Outstanding Regional Practitioner Award. Test, Treat and Vaccinate Protocol Preventing clinical Lyme disease in Lyme-positive (infected) dogs BY STEVEN A. LEVY, VMD The first canine Lyme vaccine was introduced in 1990 and demonstrated safety and efficacy in preventing Lyme disease. The first canine Lyme vaccine was introduced to the market in June 1990 at a time when infection rates with Borrelia burgdorferi were up to 50 percent1 or more in Lyme-endemic areas. Vast numbers of B. burgdorferi -infected dogs were safely immunized and efficacy in prevention of episodes of clinical Lyme disease was demonstrated. Antibiotic therapy has been demonstrated effective in resolving clinical signs in Lyme-positive dogs. Dogs presenting to veterinarians for treatment of canine Lyme arthritis may be successfully treated in 75 2,3 to 85 percent of cases with antibiotics like amoxicillin or doxycycline. Antibiotic therapy has been demonstrated to kill spirochetes4 and it is likely this is the mechanism associated with resolution of clinical signs. Incidence of clinical disease in dogs appeared to decrease between 1992 and 1993 due to prevention of new infections. In 1992, data were published1 indicating five percent of Lyme-positive dogs developed clinical signs of Lyme disease each year they were observed. While Lyme arthritis could often be successfully treated, Lyme nephritis nearly always resulted in the death or euthanasia of the pet.2,5 Incidence of episodes of Lyme disease in Lyme-positive dogs receiving Duramune® Lyme™ immunization in a 1993 JAVMA study was two percent.6 It may be hypothesized that this decrease in incidence was due to prevention of new infection or some unknown in vivo mechanism involving immune surveillance for spirochetes in the infected dog. The SNAP 3Dx patientside rapid test for Lyme infection became available in 2001. In 2001, a patient-side rapid test (SNAP 3Dx) became available for the determination of a dog’s B. burgdorferi infection status.7,8 By 2001, I had been treating acutely ill dogs with antibiotics for more than 14 years and immunizing clinically normal dogs (of which 50 percent or more were unidentified asymptomatic Lyme-positive) for 11 years. Suddenly, I was able to immediately determine the infection status of a healthy dog presented for Footnotes Levy SA, Magnarelli LA. Relationship between development of antibodies to Borrelia burgdorferi in dogs and the subsequent development of limb/joint borreliosis. JAVMA. 1992;200(3):344-347. 1 Levy SA, Dreesen DW. Lyme borreliosis in dogs. Canine Pract. 1992;17(2):5-13. 2 Levy SA. Unpublished clinical observations. 3 Philipp MW, Bowers LC, Fawcett PT, et al. Antibody response to IR6, a conserved immunodominant region of the VlsE lipoprotein, wanes rapidly after antibiotic treatment of Borrelia burgdorferi infection in experimental animals and humans. L Infect Dis. 2001;184:870-878. 4 Levy SA, Dombach DM, Barthold SW, et al. Canine Lyme borreliosis. Comp CE. 1993;15(6):833-846. 5 Levy SA, Lissman BW, Ficke CM. Performance of a Borrelia burgdorferi bacterin in borreliosis-endemic areas. JAVMA. 1993;202(11):1834-1838. 6 O’Connor TP, Esty KJ, Hanscom JL, et al. Dogs vaccinated with common Lyme disease vaccines do not respond to IR6, the conserved immunodominant region of the VlsE surface protein of Borrelia burgdorferi. Clin Diag Lab Immunol. 2004;11(3):458-462. 7 Levy SA, O’Connor TP, Hanscom JL, et al. Utility of an in-office C6 ELISA test kit for determination of infection status of dogs naturally exposed to Borrelia burgdorferi. Vet Ther. 2002;3(3):308-315. 8 continued on page 3 4 ©2010 Boehringer Ingelheim Vetmedica, Inc. All products are trademarks or registered trademarks of their manufacturers. CAN0710030 1