International journal of gynecological cancer : official journal of the International Gynecological Cancer Society
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Int. J. Gynecol. Cancer · Jul 2009
Randomized Controlled Trial Multicenter StudyImmunogenicity, reactogenicity, and safety of human papillomavirus 16/18 AS04-adjuvanted vaccine in Japanese women: interim analysis of a phase II, double-blind, randomized controlled trial at month 7.
A phase II, double-blind, controlled randomized multicenter study with human papillomavirus (HPV) 16/18 AS04 (3-O-desacyl-4'-monophosphoryl lipid A and aluminum hydroxide)-adjuvanted vaccine is ongoing in Japanese women aged 20 to 25 years. An interim analysis was performed at month 7 (1 month after the third dose of vaccine) to determine reactogenicity, safety, and immunogenicity of the vaccine and to evaluate the baseline HPV-16/18 seropositivity and DNA status of women. In the HPV-16/18 group (according-to-protocol cohort for immunogenicity analysis), 100% seroconversion was observed against HPV-16 and HPV-18 at month 6 (5 months after the second dose) and at month 7. ⋯ The immunogenicity of the HPV-16/18 vaccine and the HPV prevalence before vaccination in Japanese women are in line with what was observed in other populations. Injection site symptoms and some general symptoms were reported more frequently in the HPV-16/18 group than in the hepatitis A vaccine group but had no impact on compliance with completion of the vaccination course. Overall, the HPV-16/18 vaccine had a good safety profile, was well tolerated, and is highly immunogenic in the study population of Japanese women.
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Int. J. Gynecol. Cancer · Mar 2005
Randomized Controlled Trial Comparative Study Clinical TrialA randomized prospective study of comparison of reservoir ports versus conventional vascular access in advanced-stage ovarian carcinoma cases treated with chemotherapy.
Vascular access ports were developed to overcome many of the problems associated with limited peripheral access, combined with the need for frequent venipuncture, in oncology patients receiving long-term intensive therapy. In this study, we compared the effectivity and acceptability of vascular access port with conventional needle application together with complication rates in ovarian cancer patients. Advanced-stage ovarian carcinoma cases under chemotherapy treatment were equally randomized into two groups, implantable vascular access ports applied to one group (22 cases) and conventional vascular access applied to the other (38 cases) as a control group. ⋯ Application of reservoir ports especially to cases with advanced-stage carcinomas, under chemotherapeutic drug treatment, leads to minimal anxiety for the patient and his/her family and minimal risk of physical trauma to the patient with only one vascular access. Reservoir ports occlude or cause infection to a lesser extent than classic vascular access methods. Occlusion or infection rates of reservoir ports are statistically significant, lower than those of classic venipuncture.