ABSTRACT
BACKGROUND: The nonhuman primate model allows for safety and efficacy testing of topical microbicide products. GOAL: The goal of this study was to evaluate the safety and efficacy of vaginal and rectal applications of BufferGel (ReProtect, Inc.). STUDY DESIGN: The safety of repeated product applications was evaluated by microflora, pH, vaginal colposcopy, and rectal lavage. To test efficacy in preventing chlamydia, infection was documented by culture and nucleic acid amplification tests. RESULTS: Repeated vaginal or rectal applications of BufferGel were not associated with significant changes in microflora. BufferGel use had a transient acidifying effect on vaginal and rectal pH. Colposcopic observations remained relatively normal in all test animals. A slightly increased incidence of epithelial desquamation was noted after rectal product use compared with the control group. BufferGel did not prevent cervical or rectal chlamydial infection. CONCLUSION: BufferGel has an acceptable safety profile after repeated vaginal and rectal use, but does not prevent chlamydial infection in the macaque models.
Subject(s)
Anti-Infective Agents/administration & dosage , Chlamydia Infections/prevention & control , Spermatocidal Agents/administration & dosage , Acrylic Resins , Administration, Intravaginal , Administration, Rectal , Animals , Anti-Infective Agents/adverse effects , Chlamydia trachomatis , Female , Macaca nemestrina , Models, Animal , Rectum/microbiology , Rectum/pathology , Spermatocidal Agents/adverse effects , Vagina/microbiology , Vagina/pathologyABSTRACT
Chlamydia pneumoniae TWAR has been associated with coronary heart disease by seroepidemiologic studies and direct detection of the organism in atheromatous lesions of coronary arteries and aorta. In this study, 38 fresh tissue specimens from patients with coronary artery lesions that were treated by directional coronary atherectomy were tested for C. pneumoniae. Twenty-three specimens were from patients with primary lesions and 15 were from patients with restenoses. C. pneumoniae was detected by polymerase chain reaction (PCR), immunocytochemical stain (ICC), or both in 20 of 38 specimens. Using cell identity markers, the organism was localized to macrophages. Ultrastructural evidence of the organism was found in the 2 specimens examined by transmission electron microscopy, which were also positive by both ICC and PCR. C. pneumoniae was found more frequently in tissues from restenoses than in primary lesions (P = .17). There was no relation between the frequency of detection of the organism and C. pneumoniae-specific antibody titers.
Subject(s)
Atherectomy, Coronary , Chlamydophila pneumoniae/isolation & purification , Coronary Disease/microbiology , Adult , Aged , Aged, 80 and over , Antibodies, Bacterial/blood , Antigens, Bacterial/analysis , Chlamydophila pneumoniae/immunology , Coronary Disease/pathology , Coronary Disease/surgery , Coronary Vessels/microbiology , Coronary Vessels/pathology , DNA, Bacterial/analysis , Female , Humans , Immunohistochemistry , Male , Microscopy, Electron, Scanning , Microscopy, Electron, Scanning Transmission , Middle Aged , Polymerase Chain ReactionABSTRACT
The ultrastructural lung pathology of Swiss Webster mice on days 2, 4, 7, 11, 15, and 21 after intranasal inoculation of Chlamydia pneumoniae AR-39 is described. The inflammatory infiltrate was predominantly polymorphonuclear leukocytes on day 2. By day 7, mononuclear cells were most prominent in the infiltrate. On day 2, chlamydial inclusions were found frequently in the bronchial ciliated epithelial cells and less frequently in the interstitial cells that appeared to be macrophages. Free particles of all developmental forms of the chlamydial microorganism were found in the bronchial lumen and alveolar space. These particles were likely organisms released from infected cells. Inclusions as well as free particles were difficult to find after day 4. These ultrastructural observations suggest an immunopathologic basis for the acute phase of the disease process.
