title: Cervicovaginal evaluation in macaques used as a model for topical microbicide safety studies.
abstract: BACKGROUND
  Macaques are a commonly used non-human primate (NHP) model to evaluate safety and efficacy of topically applied vaginal microbicides. Cervicovaginal evaluation for topical microbicide safety studies requires proper technique, equipment, supplies, and sequence of sample collection.
  
  
  METHODS
  Eleven rhesus macaques received a comprehensive sequential cervicovaginal examination under sedation before treatment and 24 hours post-instillation of test material. Examination was initiated with colposcopy, followed by diagnostics including vaginal culture, pH determination, cervicovaginal lavage, and cervicovaginal biopsy.
  
  
  RESULTS
  Overall, the methods performed yielded samples that were appropriate for diagnostic evaluation and interpretation, and the macaques experienced minimal discomfort and complications.
  
  
  CONCLUSIONS
  This paper provides a descriptive summary of compiled techniques required to conduct a safety evaluation for topically applied vaginal microbicides. This novel method-based approach should be methodically executed when evaluating a vaginally-applied, topical microbicide candidate.
authors.affiliation: Department of Molecular and Comparative Pathobiology, School of Medicine, Johns Hopkins Medical Institutions, Baltimore, MD 21205, USA. dscorpio@jhmi.edu
authors.forename: Diana G
authors.initials: DG
authors.lastname: Scorpio
authors.forename: Dawn S
authors.initials: DS
authors.lastname: Ruben
authors.forename: Zhaohao
authors.initials: Z
authors.lastname: Liao
authors.forename: James E
authors.initials: JE
authors.lastname: Hildreth
authors.forename: Craig A
authors.initials: CA
authors.lastname: Fletcher
mesh_terms: D000282:Administration, Intravaginal; D000818:Animals; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D001419:Bacteria / Q000302:isolation & purification; D001706:Biopsy / Q000295:instrumentation / Q000662:veterinary; D002584:Cervix Uteri / Q000187:drug effects* / Q000382:microbiology; D003127:Colposcopy / Q000662:veterinary; D005260:Female; D006863:Hydrogen-Ion Concentration; D008253:Macaca mulatta; D023421:Models, Animal; D007507:Therapeutic Irrigation; D014621:Vagina / Q000187:drug effects* / Q000382:microbiology
chemical_list: D000890:Anti-Infective Agents