Safety, immunogenicity, and efficacy of a Clostridioides difficile toxoid vaccine candidate: a phase 3 multicentre, observer-blind, randomised, controlled trial

Autor: Enrique Rivas, Guy de Bruyn, Eng Soon Chan, Julián Torre-Cisneros, Rayo Morfin-Otero, Sanjay Gurunathan, Richard Gesser, Dhaval M Patel, Christine Rehm, Carlos Fernando De Magalhães Francesconi, Thelma Laot, Franco M. Piazza, Robert Jeanfreau, Catherine Cosgrove, Josh Chen, Mark G. Martens, Paul A. Tambyah, Theodore Steiner, Odile Launay, Steve Self, Ehab Bassily, David L. Gordon, Yoon Soo Park, Ernesto Oviedo-Orta

Publikováno v: The Lancet Infectious Diseases. 21:252-262

Summary Background In the absence of a licensed vaccine, Clostridioides (formerly Clostridium) difficile infection represents a substantial health burden. The aim of this study was to evaluate the efficacy, immunogenicity, and safety of a toxoid vacc

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3d2c078d83cc14c9bda52e9b55b89d15
https://doi.org/10.1016/s1473-3099(20)30331-5

A seamless Phase IIB/III adaptive outcome trial: Design rationale and implementation challenges

Autor: Y H Joshua Chen, Alain Luxembourg, Richard Gesser

Publikováno v: Clinical Trials. 12:84-90

Background: The licensed four-valent prophylactic human papillomavirus vaccine is highly efficacious in preventing cervical, vulvar, vaginal, and anal cancers and related precancers caused by human papillomavirus types 6, 11, 16, and 18. These four t

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::375cd9e8cde879580ce90d37b6449684
https://doi.org/10.1177/1740774514552110

A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women

Autor: Elmar A, Joura, Anna R, Giuliano, Ole-Erik, Iversen, Celine, Bouchard, Constance, Mao, Jesper, Mehlsen, Edson D, Moreira, Yuen, Ngan, Lone Kjeld, Petersen, Eduardo, Lazcano-Ponce, Punnee, Pitisuttithum, Jaime Alberto, Restrepo, Gavin, Stuart, Linn, Woelber, Yuh Cheng, Yang, Jack, Cuzick, Suzanne M, Garland, Warner, Huh, Susanne K, Kjaer, Oliver M, Bautista, Ivan S F, Chan, Joshua, Chen, Richard, Gesser, Erin, Moeller, Michael, Ritter, Scott, Vuocolo, Alain, Luxembourg, Edward, Wilkinson

Publikováno v: Joura, E A, Giuliano, A R, Iversen, O-E, Bouchard, C, Mao, C, Mehlsen, J, Moreira, E D, Ngan, Y, Petersen, L K, Lazcano-Ponce, E, Pitisuttithum, P, Restrepo, J A, Stuart, G, Woelber, L, Yang, Y C, Cuzick, J, Garland, S M, Huh, W, Kjaer, S K, Bautista, O M, Chan, I S F, Chen, J, Gesser, R, Moeller, E, Ritter, M, Vuocolo, S, Luxembourg, A & Broad Spectrum HPV Vaccine Study 2015, ' A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women ', The New England Journal of Medicine, vol. 372, no. 8, pp. 711-23 . https://doi.org/10.1056/NEJMoa1405044

BACKGROUND: The investigational 9-valent viruslike particle vaccine against human papillomavirus (HPV) includes the HPV types in the quadrivalent HPV (qHPV) vaccine (6, 11, 16, and 18) and five additional oncogenic types (31, 33, 45, 52, and 58). Her

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::090f6038e48a6cd9de7d70ad5234304c
https://pubmed.ncbi.nlm.nih.gov/26107061

Multiplexed serologic assay for nine anogenital human papillomavirus types

Autor: Richard Gesser, Richard M. Haupt, Tina Green, Mark T. Esser, Katie Matys, Alfred J. Saah, David Opalka, Paul Bojczuk, Frank J. Dutko

Publikováno v: Clinical and vaccine immunology : CVI. 17(5)

A multiplexed human papillomavirus (HPV) immunoassay has been developed for the detection of human IgG antibodies to HPV type 6, 11, 16, 18, 31, 33, 45, 52, and 58 virus-like particle (VLP) types in serum following natural infection or immunization w

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::92731565d08ab23c4d58916dba4734bc
https://pubmed.ncbi.nlm.nih.gov/20237197