Estudo multicêntrico Brasileiro - Adesivo contraceptivo transdérmico semanal: Preferência e satisfação das usuárias

Background: To assess satisfaction with the weekly transdermal contraceptive patch, compared to the previous contraceptive method. Adhesion, cycle control, safety and efficacy were secondary outcomes. Methods: A multicenter, open label, descriptive study. Subjects received the weekly transdermal contraceptive patch for 6 cycles. At the baseline and after the 1 st, 3 rd and 6 th cycles, satisfaction with the method was assessed. The contraceptive efficacy was assessed by the Pearl Index and by life table analysis. Results: An ITT analysis was performed with 494 subjects. At the endpoint, 95.3% of women were satisfied with the patch compared to the previous method; 59.5%, 58.0% and 63.2% of women reported improvement in the physical and emotional well-being, and pre-menstrual symptoms, respectively. Pre-menstrual symptoms frequency decreased from 85.0% (CI 95%: 80.8-87.4%) to 55.0% (CI 95%: 49.9-66.0%). There was a significant increase in hemoglobin levels, and also a significant decrease in total serum cholesterol and tryglicerides.. There were no significant adverse events. The adjusted Pearl Index was 1.1 pregnancies per 100 women-years. Conclusions: The weekly contraceptive transdermal patch is a safe and effective method, and there was a high rate of satisfaction with its use among brazilian women. The patch was associated to a good cycle control, with easiness of use, improvement in the physical and emotional well-being and improvement in the premenstrual symptoms and lipid profile. © Copyright Moreira Jr. Editora. Todos os direitos reservados

Induction of immune memory following administration of a prophylactic quadrivalent human papillomavirus (HPV) types 6/11/16/18 L1 virus-like particle (VLP) vaccine

Background: The duration of protection afforded by vaccines represents a critical test of their utility as public health interventions. Some vaccines induce long-term immunity, while others require booster doses. Vaccines that induce long-term protection are usually characterized by the generation of immune memory. Recent trials of a quadrivalent (types 6, 11, 16, 18) human papillomavirus (HPV) vaccine have demonstrated high efficacy through 5 years of follow-up. We evaluated the extent to which the vaccine is able to generate HPV type-specific immune memory. Methods: A total of 552, 16-23-year-old women were enrolled in a double-blind, placebo-controlled study. At enrollment, subjects were randomized in a 1:1 ratio to receive three-dose regimens of quadrivalent HPV vaccine or placebo with 3 years' follow-up. A subset of 241 subjects (n = 114 in the quadrivalent HPV vaccine group and n = 127 in the placebo group) underwent 2 further years of follow-up. All extension subjects received quadrivalent HPV vaccine at month 60 to examine the extent of immune memory in response to the primary vaccination series

Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18

Human papillomavirus (HPV) infection causes cervical cancer and genital warts. Young women (1106) were randomized to receive one of three formulations of a quadrivalent HPV (Types 6/11/16/18) L1 virus-like particle (VLP) vaccine or one of two placebo formulations. The goal was to assess vaccine safety and immunogenicity in baseline HPV 6/11/16 or 18-naive and previously infected subjects. All three formulations were highly immunogenic. At Month 2 (postdose 1), among women with vaccine-type antibodies at baseline, vaccine-induced anti-HPV responses were similar to 12- to 26-fold higher than those observed in baseline-naive women, suggesting an anamnestic response. Following an initial, similar sized decline, anti-HPV responses plateaued and remained stable through end-of-study (3.0 years). No vaccine-related serious adverse experiences were reported. (c) 2006 Elsevier Ltd. All rights reserved