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Progress, The (Newspaper) - February 24, 1999, Clearfield, Pennsylvania THE Moshannon February I got Lyme disease last spring and Im being treated for serious health I couldnt prevent it but now you Lyme Disease Vaccine Recombinant OspA Manufactured by SmithKline Beecham Belgium Distributed by SmithKline Beecham PA 19101 is a trademark of SmithKline SmithKline 1999 Lyme Disease Vaccine Recombinant OspA Brief Please see complete prescribing information m SmithKline Beecham Pharmaceuticals literature INDICATION AND USAGE is indicated lor active immunization against Lyme dis ease in individuals 15 to 70 years ol Individuals most at nsk may be those who live or work in grassy or wooded areas le g land brush and wildlife and parts as well who plan travel to or pursue recreational activities fishing and hunt ing in such Most cases ol Lyme disease in the United States are thought to bfi acquired in the through routine activities ol property mainte exercise ol pels j Previous infection with may not confer protective immunity Therefore peo ple with a prior history of Lyme disease may benefit from vaccination with Safety and efficacy for this vaccine are based on administration of the second and third doses several weeks prior to the onset ol Ihe transmission season in the local geo graphic area Isee DOSAGE AND ADMINISTRATION in complete prescribing is not a treatment lor Lyme As with any may not pro tect 100 of Do not administer to persons outside of the indicated age CONTRAINDICATIONS Contraindicated in people with known lo any component of PRECAUTIONS Ganwal will not prevent disease in those who have at the time ol vaccination not provide protection against other diseases such as or Lyme arthritis antibiotic a rare complication of infection has been associated with immune to OspA ol Since the etiology is not clearly it is recommended that not be administered lo such As with other although a moderate or severe illness is sufficient reason to postpone minor illnesses such as mild upper with or without lowgrade fever are not Before Ihe injection of arm Biological the physician should take all reasonable precautions to prevent allergic or other adverse including understanding Ihe use ol the product and Ihe nature ol the side effects and adverse reactions that may follow its Prior to immunization with any the physician should review the patients immunization history for possible vaccine previous adverse reactions and occurrence of any adverse symptoms in order to determine the existence of any contra indication to immunization and lo allow an assessment of benefits and Epinephrine injection and other appropriate agents used lor the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction Packaging lor the syringe contains dry natural which may cause allergic reactions packaging for the vial does not contain natural Use a separate sterile syringe and needle or a sterile disposable unit lor each patient to prevent transmission of infectious agents from person lo Dispose ol needles properly and do not As with any vaccine administered to per sons or persons receiving the expected immune response may not be For individuals receiving immunosuppressive consider defer ring vaccination for 3 months after 1 Laboratory Test Interactions immunization results in the generation of OspA which can be detected by an immunosorbent assay 1 ELISA tor The incidence of positive IgG ELISA tests depends on the sensitivity and specificity of the ELISA assay and the liter In gen eral there is an association between liter and IgG ELISA index or Density ratio the higher the tiler of the higher the IgG ELISA index or OD because vaccination may result in a positive IgG ELISA in the absence of it is important to perform Western blot testing if the ELISA test is positive or equivocal in vaccinated individuals who are being evaluated lor suspected Lyme Following the appearance of a 31 kD OspA possibly accompanied by other lower molecular weight bands on an immunoblot Western should not interfere with the determination of positivity when assessed by Drug Interactions No data are available on the immune response to when admin concurrently with other As with other intramuscular injections do not give to individuals on anticoagulant unless potential benefit clearly outweighs risk ol u ol Fertility has not been evaluated lor carcinogenic or mutagenic or lor impairment ol Pregnancy Effects Animal reproductive studies have not been conducted with II is also not known whether can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity Grve to a pregnant woman only if clearly Health care providers are encouraged who receive Disease Vaccine Pharmaceuticals vaccination pregnancy registry by call i Nursing It is not known whether is excreted in human milk Because many drugs are excreted in human use caution when is administered lo a nursing Usa Safety and in pediatric subjects younger than 15 years of ago have not been evaluated the vaccine is not indicated for this age group at this time 39 1 12 150 KG 1 H 1 57 263 120 1 26 1 27 1 65 52 2 45 241 247 316 293 435 498 108 7 H ials involving individuals receiving a total has been generally well Subjects with the following conditions chronic pint or neurologic illness related to Lyme disease diseases associated with joint swelling including rheumatoid arthritis or musculoskeletal pain second er block or a pacemaker were excluded Irom the efficacy trial because such conditions could interfere with the assessment of Lyme disease in the trial data are limited regarding the safety of the vaccine in with these con ditions see Unsolicited Adverse Events The most frequently reported 21 unsolicited adverse events within 30 days of vaccination for all subjects receiving at least one dose 936 in the trial are shown in Table Table Incidence of Unsolicited Adverse Events Occurring Within 30 Davs Following Each and letter Doses or 31 HKIM MB UNI 54171 SOT 90111 IN SO IH loci Injection lite pain Injection site 691 091 Fugue tern Infection viral symptom 119 103 1 135s 091 IBS 166 144s 090 1 72 1 225 205C 073 3B6 342 2 58C 161 283 245 JMC 112 104 IpM Back pain Myalgia 267 1 260 24 1 605 190 155 4B31 294 095 121 108 561 509 128 150 146 Includes events spontaneous following each dose and events repotted 1 month alter dosus 1 and 7 all subjects queried regarding itw occurrence ol any adverse event since he previous vaccination a p valued 05 b c 0001 The most frequently unsolicited adverse events occurring more than 30 days late alter vaccination tor all subjects were similar in nature to those listed in Table and most occurred at a frequency of in both the vaccine or placebo groups The only late adverse events occurring with an incidence of 5 in vaccine or placebo recipients were respectively and headache vs No significant differences in late adverse events were noted between treatment groups after any dose and Separate post hoc analyses were conducted to assess two subsets of musculoskeletal events which occurred either early days or late 30 days There were no significant either early or between Ihe vaccine and placebo recipients with regard to experiencing aggravated arthropathy or arthro vaccine recipients were significantly more likely lhan placebo recipients lo experience early events of arthralgia or myalgia after each dose for dose 1 odds ratio 95 CD dose 2 OR 1 56 dose 3 OR With regard to late events of arthralgia or there were no significant differ ences between vaccine and placebo There was no significant difference in the rates of cardiac adverse events between vaccine and placebo Neurologic adverse events which occurred at a rale 1 in the vac cine group and were noted to occur with a similar frequency in placebo recipients included carpal tunnel multiple scle myasthenia nerve root hyper km and intracranial approximately 18 of subjects enrolled in the study had a prior history of some condition 19 18 placebo recipients In a post hoc subgroup there significant difference between vaccine and placebo recipients with regard to musculoskeletal events as arthro polymyalgia bursitis or arthritis and lasting more than 30 days in those with a prior history of both vaccine and recipients with a prior history of conditions wore more likely to experience events lhan subjects without such prior Solicited Adverse Events The frequency of solicited local and systemic adverse events was evaluated in a subset of subjects who comprised the total enrollment at one study center in the efficacy Of these 938 BOO completed a 4day diary card following each of three and were evaluable according to Table 2 snows Ihe percentage of subjects reporting a solicited symptom following any one ol the doses and The majority of the solicited events wore mild to moderate in seven and limited in any 452 07 70 B 29 02 43b 7 62b 1633 any 16 83 05 1181 Ib 1633 10 3291 any severe any severe Fever 2 1910 05 005 4231 151 00 00 149 00 1231 12 05 4 98 201 00 00 100 050 00 1834 12 18 547 176 02 00 100 101 00 3719 30 28 528 02 00 348 22G 00 00 measuring 3 0 CHI and longer 24 I everyday a b 0 01 c Subjects with Previous Disease Subjects with previous Lyme disease were assessed using two definitions subjects whose sera wore evaluated lor Western blot positivity and subjects who al study a previous history disease Study participants did not routinely have sera tested by WB lor disease WB WaS who were noted to haVo a i no or determined to have been at baseline to determined to have been at 151 There were subjects enrolled in the study who a previous ol Lyme disease 610 696 placebo recipients For adverse s Sum g the first 30 there was an increased incidence ol symptoms Tin vac with no inco of psy system disor orders between vaccine and placebo recipients with a prior history ol Lymo disease thn in CMK j u Subjects with a prior history ol Lyme disease had a greater incident disorders early and and autonomic nervous svs ders and gastrointestinal disorders fete than subjects win no prior histor V i seventy Table Tht Incidence of Local and Solicited Including 4021 Ml I IN IN Ml local Symptom any severe any severe any Hc 829 00 81 3868 12 00 427 00 704 r 10 oo 7037C 3090 10 03 327 00 1181 00 82 52 26 03 67B 05 2085 42C 00 9353C 6809 00 29B5C 1131 05 00 As with all it is possible that expanded commercial use ol the could reveal rare adverse events not observed in clinical studios vaccine Manufactured by SmithKline Beecham Belgium Distributed by SmithKline Beecham Pharmaceuticals PA 19101 SmithKline 1993 and trademarks of Beecham
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