Phase 2b Controlled Trial of M72/AS01E Vaccine to Prevent Tuberculosis
Olivier Van Der Meeren,Mark Hatherill,Videlis Nduba,Robert J. Wilkinson,Monde Muyoyeta,Elana van Brakel,Helen Ayles,German Henostroza,Friedrich Thienemann,Thomas J. Scriba,Andreas H. Diacon,Gretta L Blatner,Marie-Ange Demoitié,Michele Tameris,Mookho Malahleha,James C Innes,Elizabeth Hellstrom,Neil A. Martinson,Tina Singh,Elaine J Akite,Aisha Khatoon Azam,Anne Bollaerts,Ann M. Ginsberg,Thomas G. Evans,Paul Gillard,Dereck Tait +25 more
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M72/AS01E provided 54.0% protection for M. tuberculosis–infected adults against active pulmonary tuberculosis disease, without evident safety concerns, in a phase 2b trial in Kenya, South Africa, and Zambia.Abstract:
Background A vaccine to interrupt the transmission of tuberculosis is needed. Methods We conducted a randomized, double-blind, placebo-controlled, phase 2b trial of the M72/AS01E tuberculosis vaccine in Kenya, South Africa, and Zambia. Human immunodeficiency virus (HIV)–negative adults 18 to 50 years of age with latent M. tuberculosis infection (by interferon-γ release assay) were randomly assigned (in a 1:1 ratio) to receive two doses of either M72/AS01E or placebo intramuscularly 1 month apart. Most participants had previously received the bacille Calmette–Guerin vaccine. We assessed the safety of M72/AS01E and its efficacy against progression to bacteriologically confirmed active pulmonary tuberculosis disease. Clinical suspicion of tuberculosis was confirmed with sputum by means of a polymerase-chain-reaction test, mycobacterial culture, or both. Results We report the primary analysis (conducted after a mean of 2.3 years of follow-up) of the ongoing trial. A total of 1786 participants receive...read more
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Final Analysis of a Trial of M72/AS01E Vaccine to Prevent Tuberculosis
Dereck Tait,M. Hatherill,Olivier Van Der Meeren,Ann M. Ginsberg,Elana van Brakel,Bruno Salaun,Thomas J. Scriba,Elaine J Akite,Helen Ayles,Anne Bollaerts,Marie-Ange Demoitié,Andreas Diacon,Thomas G. Evans,Paul Gillard,Elizabeth Hellstrom,James C Innes,Maria Lempicki,Mookho Malahleha,Neil A. Martinson,Doris Mesia Vela,Monde Muyoyeta,Videlis Nduba,Thierry G. Pascal,Michele Tameris,Friedrich Thienemann,Robert J. Wilkinson,François Roman +26 more
TL;DR: Among adults infected with M. tuberculosis, vaccination with M72/AS01E elicited an immune response and provided protection against progression to pulmonary tuberculosis disease for at least 3 years, with similar frequencies in the two groups.
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Building a tuberculosis-free world: The Lancet Commission on tuberculosis
Michael J. A. Reid,Nimalan Arinaminpathy,Amy Bloom,Barry R. Bloom,Catharina Boehme,Richard E. Chaisson,Daniel P. Chin,Gavin J. Churchyard,Helen Cox,Lucica Ditiu,Mark Dybul,Jeremy Farrar,Anthony S. Fauci,Endalkachew Fekadu,Paula I Fujiwara,Timothy B. Hallett,Christy L Hanson,Mark Harrington,Nick Herbert,Philip C. Hopewell,Chieko Ikeda,Dean T. Jamison,Aamir J. Khan,Irene Koek,Nalini Krishnan,Aaron Motsoaledi,Madhukar Pai,Mario C. Raviglione,Mario C. Raviglione,Almaz Sharman,Small Pm,Soumya Swaminathan,Zelalem Temesgen,Anna Vassall,Anna Vassall,Nandita. Venkatesan,Kitty van Weezenbeek,Gavin Yamey,Bruce D. Agins,Sofia Alexandru,Jason R. Andrews,Naomi Beyeler,Stela Bivol,Grania Brigden,Adithya Cattamanchi,Danielle Cazabon,Valeriu Crudu,Amrita Daftary,Puneet Dewan,Laurie K Doepel,Robert W Eisinger,Victoria Y. Fan,Victoria Y. Fan,Sara Fewer,Jennifer Furin,Jeremy D. Goldhaber-Fiebert,Gabriela B. Gomez,Stephen M. Graham,Stephen M. Graham,Stephen M. Graham,Devesh Gupta,Maureen Kamene,Sunil D. Khaparde,Eunice W Mailu,Enos Masini,Lorrie McHugh,Ellen M. H. Mitchell,Suerie Moon,Suerie Moon,Michael Osberg,Tripti Pande,Lea Prince,Kirankumar Rade,Raghuram Rao,Michelle Remme,James A Seddon,James A Seddon,Casey Selwyn,Priya B. Shete,Kuldeep Singh Sachdeva,Guy Stallworthy,Juan F. Vesga,Valentina Vilc,Eric Goosby +83 more
TL;DR: The Commission recommends five priority investments to achieve a tuberculosis-free world within a generation, which answer the question of how countries with high-burden tuberculosis and their development partners should target their future investments.
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Chelsea N. Fries,Elizabeth J. Curvino,Jui-Lin Chen,Sallie R. Permar,Genevieve G. Fouda,Joel H. Collier +5 more
TL;DR: This Review will discuss aspects along with recent nanomaterial advances towards vaccines against infectious disease, with a particular emphasis on HIV/AIDS, malaria and tuberculosis, which are not yet treatable with vaccination.
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Why and How Vaccines Work.
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TL;DR: Several lines of evidence suggest that alternative mechanisms-including pharmacokinetic variability, induction of efflux pumps that transport the drug out of cells, and suboptimal drug penetration into tuberculosis lesions-are likely crucial to the pathogenesis of drug-resistant tuberculosis.
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