Three-year Efficacy and Safety of Takeda’s Dengue Vaccine Candidate (TAK-003)
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2021 |
| Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
| Texto Completo: | https://www.arca.fiocruz.br/handle/icict/49861 |
Resumo: | 1Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic; 2Takeda Vaccines, Inc., Boston, Massachusetts, USA; 3Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at SENACYT, Centro de Vacunación Internacional (Cevaxin), Panama City, Panama; 4Centro de Atención e Investigación Médica, CAIMED, Bogotá, Colombia; 5Centro de Estudios en Infectología Pediátrica, Universidad del Valle and Centro Medico Imbanaco, Cali, Colombia; 6Research Institute For Tropical Medicine, Muntinlupa, Philippines; 7University of the Philippines Manila, Ermita, Philippines; 8Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; 9Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand; 10CAIMED, Dominicana, Santo Domingo, Dominican Republic; 11De La Salle Medical and Health Sciences Institute, Dasmariñas, Philippines; 12Phramongkutklao Hospital, Bangkok, Thailand; 13National Autonomous University of Nicaragua, León, Nicaragua; 14Núcleo de Doenças Infecciosas, Centro de Ciencias da Saude-UFES, Vitória, Brazil; 15Centre for Clinical Management of Dengue & Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka; 16University of Colombo, Colombo, Sri Lanka; 17Associação Obras Sociais Irmã Dulce Hospital Santo Antônio and Oswaldo Cruz Foundation, Bahia, Brazil; 18Faculty of Medicine, University of Kelaniya, Colombo, Sri Lanka; 19Faculty of Medical Sciences, University of Sri Jayawardenenpura, Colombo, Sri Lanka; 20Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal, Brazil; 21Universidade Federal de Mato Grosso do Sul, Campo Grande, Brazil; 22Takeda Pharmaceuticals International AG, Zurich, Switzerland; and 23Philippines-Armed Forces Research Institute of Medical Sciences Virology Research Unit, Cebu City, Philippines |
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Rivera, LuisBiswal, ShibadasLlorens, Xavier SáezReynales, HumbertoMedina, Eduardo LópezTabora, Charissa BorjaBravo, LuluSirivichayakul, ChukiatKosalaraksa, PopeVargas, Luis MartinezYu, DeliaWatanaveeradej, VeerachaiEspinoza, FelixDietze, ReynaldoFernando, LakKumarWickramasinghe, PujithaMoreira Junior, Edson DuarteFernando, Asvini D.Gunasekera, DulanieLuz, KleberCunha, Rivaldo Venâncio daRauscher, MartinaZent, OlafLiu, MengyaHoffman, ElaineLeFevre, IngeTricou, VianneyWallace, DerekAlera, Maria TheresaBorkowski, AstridTIDES study group2021-11-17T18:39:55Z2021-11-17T18:39:55Z2021RIVERA, Luis et al. Three-year Efficacy and Safety of Takeda’s Dengue Vaccine Candidate (TAK-003). Clinical Infectious Diseases, 2021.1058-4838https://www.arca.fiocruz.br/handle/icict/4986110.1093/cid/ciab8641Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic; 2Takeda Vaccines, Inc., Boston, Massachusetts, USA; 3Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at SENACYT, Centro de Vacunación Internacional (Cevaxin), Panama City, Panama; 4Centro de Atención e Investigación Médica, CAIMED, Bogotá, Colombia; 5Centro de Estudios en Infectología Pediátrica, Universidad del Valle and Centro Medico Imbanaco, Cali, Colombia; 6Research Institute For Tropical Medicine, Muntinlupa, Philippines; 7University of the Philippines Manila, Ermita, Philippines; 8Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; 9Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand; 10CAIMED, Dominicana, Santo Domingo, Dominican Republic; 11De La Salle Medical and Health Sciences Institute, Dasmariñas, Philippines; 12Phramongkutklao Hospital, Bangkok, Thailand; 13National Autonomous University of Nicaragua, León, Nicaragua; 14Núcleo de Doenças Infecciosas, Centro de Ciencias da Saude-UFES, Vitória, Brazil; 15Centre for Clinical Management of Dengue & Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka; 16University of Colombo, Colombo, Sri Lanka; 17Associação Obras Sociais Irmã Dulce Hospital Santo Antônio and Oswaldo Cruz Foundation, Bahia, Brazil; 18Faculty of Medicine, University of Kelaniya, Colombo, Sri Lanka; 19Faculty of Medical Sciences, University of Sri Jayawardenenpura, Colombo, Sri Lanka; 20Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal, Brazil; 21Universidade Federal de Mato Grosso do Sul, Campo Grande, Brazil; 22Takeda Pharmaceuticals International AG, Zurich, Switzerland; and 23Philippines-Armed Forces Research Institute of Medical Sciences Virology Research Unit, Cebu City, PhilippinesTakeda Vaccines; Takeda Pharmaceuticals International AG."Múltipla ver em Notas"Background: Takeda’s live attenuated tetravalent dengue vaccine candidate (TAK-003) is under evaluation in a long-term clinical trial across 8 dengue-endemic countries. Previously, we have reported its efficacy and safety in both seronegative and seropositive participants and that its performance varies by serotype, with some decline in efficacy from first to second year postvaccination. This exploratory analysis provides an update with cumulative and third-year data. Methods: Healthy 4–16 year olds (n = 20 099) were randomized 2:1 to receive TAK-003 or placebo (0, 3 month schedule). The protocol included baseline serostatus testing of all participants and detection of all symptomatic dengue throughout the trial with a serotype specific reverse transcriptase-polymerase chain reaction. Results: Cumulative efficacy after 3 years was 62.0% (95% confidence interval, 56.6–66.7) against virologically confirmed dengue (VCD) and 83.6% (76.8–88.4) against hospitalized VCD. Efficacy was 54.3% (41.9–64.1) against VCD and 77.1% (58.6–87.3) against hospitalized VCD in baseline seronegatives, and 65.0% (58.9–70.1) against VCD and 86.0% (78.4–91.0) against hospitalized VCD in baseline seropositives. Efficacy against VCD during the third year declined to 44.7% (32.5–54.7), whereas efficacy against hospitalized VCD was sustained at 70.8% (49.6–83.0). Rates of serious adverse events were 2.9% in TAK-003 group and 3.5% in placebo group during the ongoing long-term follow-up (ie, second half of the 3 years following vaccination), but none were related. No important safety risks were identified. Conclusions: TAK-003 was efficacious against symptomatic dengue over 3 years. Efficacy declined over time but remained robust against hospitalized dengue. A booster dose evaluation is planned.engOxford University PressCriançasDengueEficáciaSegurançaVacinaChildrenDengueEfficacySafetyVaccineThree-year Efficacy and Safety of Takeda’s Dengue Vaccine Candidate (TAK-003)info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83097https://www.arca.fiocruz.br/bitstream/icict/49861/1/license.txt36b51ef91c52b5338d9d29ba0cc807bcMD51ORIGINALRivera, Luis Three-year efficacy....pdfRivera, Luis Three-year efficacy....pdfapplication/pdf7194254https://www.arca.fiocruz.br/bitstream/icict/49861/2/Rivera%2c%20Luis%20Three-year%20efficacy....pdf1f6ca160dc2250b1962c395166c2a2beMD52icict/498612023-03-15 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| dc.title.pt_BR.fl_str_mv |
Three-year Efficacy and Safety of Takeda’s Dengue Vaccine Candidate (TAK-003) |
| title |
Three-year Efficacy and Safety of Takeda’s Dengue Vaccine Candidate (TAK-003) |
| spellingShingle |
Three-year Efficacy and Safety of Takeda’s Dengue Vaccine Candidate (TAK-003) Rivera, Luis Crianças Dengue Eficácia Segurança Vacina Children Dengue Efficacy Safety Vaccine |
| title_short |
Three-year Efficacy and Safety of Takeda’s Dengue Vaccine Candidate (TAK-003) |
| title_full |
Three-year Efficacy and Safety of Takeda’s Dengue Vaccine Candidate (TAK-003) |
| title_fullStr |
Three-year Efficacy and Safety of Takeda’s Dengue Vaccine Candidate (TAK-003) |
| title_full_unstemmed |
Three-year Efficacy and Safety of Takeda’s Dengue Vaccine Candidate (TAK-003) |
| title_sort |
Three-year Efficacy and Safety of Takeda’s Dengue Vaccine Candidate (TAK-003) |
| author |
Rivera, Luis |
| author_facet |
Rivera, Luis Biswal, Shibadas Llorens, Xavier Sáez Reynales, Humberto Medina, Eduardo López Tabora, Charissa Borja Bravo, Lulu Sirivichayakul, Chukiat Kosalaraksa, Pope Vargas, Luis Martinez Yu, Delia Watanaveeradej, Veerachai Espinoza, Felix Dietze, Reynaldo Fernando, LakKumar Wickramasinghe, Pujitha Moreira Junior, Edson Duarte Fernando, Asvini D. Gunasekera, Dulanie Luz, Kleber Cunha, Rivaldo Venâncio da Rauscher, Martina Zent, Olaf Liu, Mengya Hoffman, Elaine LeFevre, Inge Tricou, Vianney Wallace, Derek Alera, Maria Theresa Borkowski, Astrid TIDES study group |
| author_role |
author |
| author2 |
Biswal, Shibadas Llorens, Xavier Sáez Reynales, Humberto Medina, Eduardo López Tabora, Charissa Borja Bravo, Lulu Sirivichayakul, Chukiat Kosalaraksa, Pope Vargas, Luis Martinez Yu, Delia Watanaveeradej, Veerachai Espinoza, Felix Dietze, Reynaldo Fernando, LakKumar Wickramasinghe, Pujitha Moreira Junior, Edson Duarte Fernando, Asvini D. Gunasekera, Dulanie Luz, Kleber Cunha, Rivaldo Venâncio da Rauscher, Martina Zent, Olaf Liu, Mengya Hoffman, Elaine LeFevre, Inge Tricou, Vianney Wallace, Derek Alera, Maria Theresa Borkowski, Astrid TIDES study group |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.contributor.author.fl_str_mv |
Rivera, Luis Biswal, Shibadas Llorens, Xavier Sáez Reynales, Humberto Medina, Eduardo López Tabora, Charissa Borja Bravo, Lulu Sirivichayakul, Chukiat Kosalaraksa, Pope Vargas, Luis Martinez Yu, Delia Watanaveeradej, Veerachai Espinoza, Felix Dietze, Reynaldo Fernando, LakKumar Wickramasinghe, Pujitha Moreira Junior, Edson Duarte Fernando, Asvini D. Gunasekera, Dulanie Luz, Kleber Cunha, Rivaldo Venâncio da Rauscher, Martina Zent, Olaf Liu, Mengya Hoffman, Elaine LeFevre, Inge Tricou, Vianney Wallace, Derek Alera, Maria Theresa Borkowski, Astrid TIDES study group |
| dc.subject.other.pt_BR.fl_str_mv |
Crianças Dengue Eficácia Segurança Vacina |
| topic |
Crianças Dengue Eficácia Segurança Vacina Children Dengue Efficacy Safety Vaccine |
| dc.subject.en.pt_BR.fl_str_mv |
Children Dengue Efficacy Safety Vaccine |
| description |
1Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic; 2Takeda Vaccines, Inc., Boston, Massachusetts, USA; 3Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at SENACYT, Centro de Vacunación Internacional (Cevaxin), Panama City, Panama; 4Centro de Atención e Investigación Médica, CAIMED, Bogotá, Colombia; 5Centro de Estudios en Infectología Pediátrica, Universidad del Valle and Centro Medico Imbanaco, Cali, Colombia; 6Research Institute For Tropical Medicine, Muntinlupa, Philippines; 7University of the Philippines Manila, Ermita, Philippines; 8Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; 9Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand; 10CAIMED, Dominicana, Santo Domingo, Dominican Republic; 11De La Salle Medical and Health Sciences Institute, Dasmariñas, Philippines; 12Phramongkutklao Hospital, Bangkok, Thailand; 13National Autonomous University of Nicaragua, León, Nicaragua; 14Núcleo de Doenças Infecciosas, Centro de Ciencias da Saude-UFES, Vitória, Brazil; 15Centre for Clinical Management of Dengue & Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka; 16University of Colombo, Colombo, Sri Lanka; 17Associação Obras Sociais Irmã Dulce Hospital Santo Antônio and Oswaldo Cruz Foundation, Bahia, Brazil; 18Faculty of Medicine, University of Kelaniya, Colombo, Sri Lanka; 19Faculty of Medical Sciences, University of Sri Jayawardenenpura, Colombo, Sri Lanka; 20Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal, Brazil; 21Universidade Federal de Mato Grosso do Sul, Campo Grande, Brazil; 22Takeda Pharmaceuticals International AG, Zurich, Switzerland; and 23Philippines-Armed Forces Research Institute of Medical Sciences Virology Research Unit, Cebu City, Philippines |
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2021 |
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2021-11-17T18:39:55Z |
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2021-11-17T18:39:55Z |
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2021 |
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RIVERA, Luis et al. Three-year Efficacy and Safety of Takeda’s Dengue Vaccine Candidate (TAK-003). Clinical Infectious Diseases, 2021. |
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https://www.arca.fiocruz.br/handle/icict/49861 |
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1058-4838 |
| dc.identifier.eissn.none.fl_str_mv |
10.1093/cid/ciab864 |
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RIVERA, Luis et al. Three-year Efficacy and Safety of Takeda’s Dengue Vaccine Candidate (TAK-003). Clinical Infectious Diseases, 2021. 1058-4838 10.1093/cid/ciab864 |
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https://www.arca.fiocruz.br/handle/icict/49861 |
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