Immunogenicity and safety of one versus two doses of tetravalent dengue vaccine in healthy children aged 2–17 years in Asia and Latin America: 18-month interim data from a phase 2, randomised, placebo-controlled study

The Lancet Infectious Diseases - Tập 18 - Trang 162-170 - 2018
Xavier Sáez-Llorens1,2, Vianney Tricou3, Delia Yu4, Luis Rivera5, José Jimeno6, Ana Cecilia Villarreal6, Epiphany Dato4, Sonia Mazara5, Maria Vargas5, Manja Brose7, Martina Rauscher7, Suely Tuboi8, Astrid Borkowski7, Derek Wallace7
1Hospital del Niño Dr. José Renán Esquivel, Panama City, Panama
2Sistema Nacional de Investigación, SENACYT, Panama City, Panama
3Takeda Vaccines, Singapore, Singapore
4De La Salle Health Sciences Institute, Cavite, Philippines
5Hospital Universitario Maternidad Nuestra Señora de la Altagracia, Santo Domingo, Dominican Republic
6Centro de Vacunación Internacional S A (Cevaxin), Panama City, Panama
7Takeda Pharmaceuticals International, Zurich, Switzerland
8Takeda Pharmaceuticals, Rio de Janeiro, Brazil

Tài liệu tham khảo

Bhatt, 2013, The global distribution and burden of dengue, Nature, 496, 504, 10.1038/nature12060 2009 Bhatia, 2013, Changing epidemiology of dengue in South-East Asia, WHO South East Asia J Public Health, 2, 23, 10.4103/2224-3151.115830 Sabchareon, 2012, Protective efficacy of the recombinant, live-attenuated, CYD tetravalent dengue vaccine in Thai schoolchildren: a randomised, controlled phase 2b trial, Lancet, 380, 1559, 10.1016/S0140-6736(12)61428-7 Simmons, 2012, Dengue, N Engl J Med, 366, 1423, 10.1056/NEJMra1110265 Guzmán, 2002, Dengue: an update, Lancet Infect Dis, 2, 33, 10.1016/S1473-3099(01)00171-2 Huy, 2010, National dengue surveillance in Cambodia 1980–2008: epidemiological and virological trends and the impact of vector control, Bull World Health Organ, 88, 650, 10.2471/BLT.09.073908 Wilder-Smith, 2017, Epidemic arboviral diseases: priorities for research and public health, Lancet Infect Dis, 17, e101, 10.1016/S1473-3099(16)30518-7 Capeding, 2014, Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial, Lancet, 384, 1358, 10.1016/S0140-6736(14)61060-6 Hadinegoro, 2015, Efficacy and long-term safety of a dengue vaccine in regions of endemic disease, N Engl J Med, 373, 1195, 10.1056/NEJMoa1506223 Vigne, 2017, Integrated immunogenicity analysis of a tetravalent dengue vaccine up to 4 y after vaccination, Hum Vaccin Immunother, 13, 2004, 10.1080/21645515.2017.1333211 Villar, 2015, Efficacy of a tetravalent dengue vaccine in children in Latin America, N Engl J Med, 372, 113, 10.1056/NEJMoa1411037 Kinney, 1997, Construction of infectious cDNA clones for dengue 2 virus: strain 16681 and its attenuated vaccine derivative, strain PDK-53, Virology, 230, 300, 10.1006/viro.1997.8500 Butrapet, 2000, Attenuation markers of a candidate dengue type 2 vaccine virus, strain 16681 (PDK-53), are defined by mutations in the 5′ noncoding region and nonstructural proteins 1 and 3, J Virol, 74, 3011, 10.1128/JVI.74.7.3011-3019.2000 Huang, 2003, Dengue 2 PDK-53 virus as a chimeric carrier for tetravalent dengue vaccine development, J Virol, 77, 11436, 10.1128/JVI.77.21.11436-11447.2003 Osorio, 2011, Development of DENVax: a chimeric dengue-2 PDK-53-based tetravalent vaccine for protection against dengue fever, Vaccine, 29, 7251, 10.1016/j.vaccine.2011.07.020 Huang, 2013, Genetic and phenotypic characterization of manufacturing seeds for a tetravalent dengue vaccine (DENVax), PLoS Negl Trop Dis, 7, e2243, 10.1371/journal.pntd.0002243 Osorio, 2016, A recombinant, chimeric tetravalent dengue vaccine candidate based on a dengue virus serotype 2 backbone, Expert Rev Vaccines, 15, 497, 10.1586/14760584.2016.1128328 George, 2015, Safety and immunogenicity of a live attenuated tetravalent dengue vaccine candidate in flavivirus-naive adults: a randomized, double-blinded phase 1 clinical trial, J Infect Dis, 212, 1032, 10.1093/infdis/jiv179 Osorio, 2014, Safety and immunogenicity of a recombinant live attenuated tetravalent dengue vaccine (DENVax) in flavivirus-naive healthy adults in Colombia: a randomised, placebo-controlled, phase 1 study, Lancet Infect Dis, 14, 830, 10.1016/S1473-3099(14)70811-4 Rupp, 2015, Safety and immunogenicity of different doses and schedules of a live attenuated tetravalent dengue vaccine (TDV) in healthy adults: a phase 1b randomized study, Vaccine, 33, 6351, 10.1016/j.vaccine.2015.09.008 Sirivichayakul, 2016, Safety and immunogenicity of a tetravalent dengue vaccine candidate in healthy children and adults in dengue-endemic regions: a randomized, placebo-controlled phase 2 study, J Infect Dis, 213, 1562, 10.1093/infdis/jiv762 Saez-Llorens, 2017, Safety and immunogenicity of one versus two doses of Takeda's tetravalent dengue vaccine in children in Asia and Latin America: interim results from a phase 2, randomised, placebo-controlled study, Lancet Infect Dis, 17, 615, 10.1016/S1473-3099(17)30166-4 Santiago, 2013, Analytical and clinical performance of the CDC real time RT-PCR assay for detection and typing of dengue virus, PLoS Negl Trop Dis, 7, e2311, 10.1371/journal.pntd.0002311 Prymula, 2014, Protection against varicella with two doses of combined measles-mumps-rubella-varicella vaccine versus one dose of monovalent varicella vaccine: a multicentre, observer-blind, randomised, controlled trial, Lancet, 383, 1313, 10.1016/S0140-6736(12)61461-5 Ngai, 1996, Safety and immunogenicity of one vs. two injections of Oka/Merck varicella vaccine in healthy children, Pediatr Infect Dis J, 15, 49, 10.1097/00006454-199601000-00011 Wellington, 2003, Measles, mumps, rubella vaccine (Priorix; GSK-MMR): a review of its use in the prevention of measles, mumps and rubella, Drugs, 63, 2107, 10.2165/00003495-200363190-00012 Osorio, 2015, Development of a recombinant, chimeric tetravalent dengue vaccine candidate, Vaccine, 33, 7112, 10.1016/j.vaccine.2015.11.022 Marin, 2016, Global varicella vaccine effectiveness: a meta-analysis, Pediatrics, 137, 1, 10.1542/peds.2015-3741 Soares-Weiser, 2012, Vaccines for preventing rotavirus diarrhoea: vaccines in use, Cochrane Database Syst Rev, 11, 10.1002/14651858.CD008521.pub2