a randomized, placebo-controlled trial of the bivalent killed, whole-cell, oral cholera vaccine in adults and children in a cholera endemic area in kolkata, india一项随机、安慰剂对照试验的二价杀,全细胞,在成人和儿童口服霍乱疫苗在霍乱流行地区在加尔各答,印度.pdfVIP

A Randomized, Placebo-Controlled Trial of the Bivalent Killed, Whole-Cell, Oral Cholera Vaccine in Adults and Children in a Cholera Endemic Area in Kolkata, India 1 2 3 2 3 Dilip Mahalanabis , Anna Lena Lopez *, Dipika Sur , Jacqueline Deen , Byomkesh Manna , Suman 3 2 2 2,6 2 Kanungo , Lorenz von Seidlein , Rodney Carbis , Seung Hyun Han , Seong Hye Shin , Stephen 5 4 5 2 3 Attridge , Raman Rao , Jan Holmgren , John Clemens , Sujit K. Bhattacharya 1 Society for Applied Studies, Kolkata, India, 2 International Vaccine Institute, Seoul, Korea, 3 National Institute of Cholera and Enteric Diseases, Kolkata, India, 4 Shantha Biotechnics, Hyderabad, India, 5 University of Gothenburg, Gothenburg, Sweden, 6 Seoul National University, Seoul, Korea Abstract Objectives: An effective vaccine against cholera has been used for public health purposes in Vietnam since the 1990s. This vaccine was reformulated to meet WHO requirements. We assessed the safety and immunogenicity of the reformulated bivalent (Vibrio cholerae 01 and 0139) killed whole cell oral vaccine in a cholera endemic area in Kolkata, India. Design: Double-blind, randomized, placebo controlled trial Setting: The trial was conducted in the clinical trial ward of the Infectious Diseases Hospital in Kolkata, India Participants: The participants were 101 healthy adults (males and non-pregnant females) aged 18–40 years and 100 healthy children (males and non-pregnant females) aged 1–17 years. Interventions: Participants were randomized to receive