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PURPOSE: Non-surgical treatments for cervical intraepithelial neoplasia 2/3 (CIN2/3) are needed as surgical treatments have been shown to double preterm delivery rate. The goal of this study was to demonstrate safety of a human papillomavirus (HPV) therapeutic vaccine called PepCan, which consists of four current good-manufacturing production-grade peptides covering the HPV type 16 E6 protein and Candida skin test reagent as a novel adjuvant. PATIENTS AND METHODS: The study was a single-arm, single-institution, dose-escalation phase I clinical trial, and the patients (n = 24) were women with biopsy-proven CIN2/3. Four injections were administered intradermally every 3 weeks in limbs. Loop electrical excision procedure (LEEP) was performed 12 weeks after the last injection for treatment and histological analysis. Six subjects each were enrolled (50, 100, 250, and 500 µg per peptide). RESULTS: The most common adverse events (AEs) were injection site reactions, and none of the patients experienced dose-limiting toxicities. The best histological response was seen at the 50 µg dose level with a regression rate of 83% (n = 6), and the overall rate was 52% (n = 23). Vaccine-induced immune responses to E6 were detected in 65% of recipients (significantly in 43%). Systemic T-helper type 1 (Th1) cells were significantly increased after four vaccinations (P = 0.02). CONCLUSION: This study demonstrated that PepCan is safe. A significantly increased systemic level of Th1 cells suggests that Candida, which induces interleukin-12 (IL-12) in vitro, may have a Th1 promoting effect. A phase II clinical trial to assess the full effect of this vaccine is warranted.
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UNLABELLED: Telemedicine has been advertised for increasing efficiency, extending the scope of obstetric practice, improving pregnancy outcomes, and reducing costs in the healthcare system. The extent of telemedicine use in obstetrics was identified with a literature search. A total of 268 articles were identified of which 60 are the basis for this review. Telemedicine has been used to read ultrasounds, interpret nonstress tests, counsel patients, manage diabetes, manage postpartum depression, and support parents and children postpartum from remote sites. Reductions in time lost from work, transportation costs, more efficiency for the health care providers, and reducing medical costs all have been suggested as benefits of telemedicine. Despite the information published about telemedicine in obstetrics, this technology has not been shown to have adverse effects in obstetrics but neither has it demonstrated unequivocal benefits. Properly structured and powered investigations will be needed to determine the role of telemedicine in the future. TARGET AUDIENCE: Obstetricians & Gynecologists. LEARNING OBJECTIVES: After completing this CME activity, physicians should be better able to diagnose and treat diabetes using telemedicine techniques; assess the current scope of research in telemedicine in obstetrics; implement clinical telemedicine consultations based on the interaction and the needs of the participants; and the opportunities for further research in telemedicine in obstetrics.