title: Safety and efficacy of a xenogeneic DNA vaccine encoding for human tyrosinase as adjunctive treatment for oral malignant melanoma in dogs following surgical excision of the primary tumor.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of a vaccine containing plasmid DNA with an insert encoding human tyrosinase (ie, huTyr vaccine) as adjunctive treatment for oral malignant melanoma (MM) in dogs.
  
  
  METHODS
  111 dogs (58 prospectively enrolled in a multicenter clinical trial and 53 historical controls) with stage II or III oral MM (modified World Health Organization staging scale, I to IV) in which locoregional disease control was achieved.
  
  
  METHODS
  58 dogs received an initial series of 4 injections of huTyr vaccine (102 μg of DNA/injection) administered transdermally by use of a needle-free IM vaccination device. Dogs were monitored for adverse reactions. Surviving dogs received booster injections at 6-month intervals thereafter. Survival time for vaccinates was compared with that of historical control dogs via Kaplan-Meier survival analysis for the outcome of death.
  
  
  RESULTS
  Kaplan-Meier analysis of survival time until death attributable to MM was determined to be significantly improved for dogs that received the huTyr vaccine, compared with that of historical controls. However, median survival time could not be determined for vaccinates because < 50% died of MM before the end of the observation period. No systemic reactions requiring veterinary intervention were associated with vaccination. Local reactions were primarily limited to acute wheal or hematoma formation, mild signs of pain at the injection site, and postvaccination bruising.
  
  
  CONCLUSIONS
  Results support the safety and efficacy of the huTyr DNA vaccine in dogs as adjunctive treatment for oral MM.
  
  
  CONCLUSIONS
  Response to DNA vaccination in dogs with oral MM may be useful in development of plasmid DNA vaccination protocols for human patients with similar disease.
authors: Merial Limited, 1730 Olympic Dr, Athens, GA 30601, USA. Deborah.Grosenbaugh@merial.com
authors: Deborah A
authors: DA
authors: Grosenbaugh
authors: A Timothy
authors: AT
authors: Leard
authors: Philip J
authors: PJ
authors: Bergman
authors: Mary K
authors: MK
authors: Klein
authors: Karri
authors: K
authors: Meleo
authors: Steven
authors: S
authors: Susaneck
authors: Paul R
authors: PR
authors: Hess
authors: Monika K
authors: MK
authors: Jankowski
authors: Pamela D
authors: PD
authors: Jones
authors: Nicole F
authors: NF
authors: Leibman
authors: Maribeth H
authors: MH
authors: Johnson
authors: Ilene D
authors: ID
authors: Kurzman
authors: Jedd D
authors: JD
authors: Wolchok
mesh_terms: D000279:Administration, Cutaneous; D000818:Animals; D019496:Cancer Vaccines / Q000276:immunology / Q000627:therapeutic use*; D018076:DNA, Complementary / Q000235:genetics / Q000627:therapeutic use; D004283:Dog Diseases / Q000188:drug therapy* / Q000276:immunology; D004285:Dogs; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008545:Melanoma / Q000188:drug therapy / Q000276:immunology / Q000662:veterinary*; D014442:Monophenol Monooxygenase / Q000235:genetics / Q000627:therapeutic use*; D009062:Mouth Neoplasms / Q000188:drug therapy / Q000276:immunology / Q000662:veterinary*; D009367:Neoplasm Staging / Q000662:veterinary; D019647:Oral Surgical Procedures / Q000662:veterinary; D010957:Plasmids / Q000235:genetics / Q000627:therapeutic use; D011446:Prospective Studies; D016896:Treatment Outcome; D014481:United States; D019444:Vaccines, DNA / Q000276:immunology / Q000627:therapeutic use*
chemical_list: D019496:Cancer Vaccines; D018076:DNA, Complementary; D019444:Vaccines, DNA; D014442:Monophenol Monooxygenase