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Efficacy of a Dengue Vaccine Candidate (TAK-003) in Healthy Children and Adolescents 2 Years after Vaccination
BACKGROUND: Takeda’s dengue vaccine is under evaluation in an ongoing phase 3 efficacy study; we present a 2-year update. METHODS: Children (20 099, 4–16 years old) were randomized to receive 2 doses of TAK-003 or placebo 3 months apart and are under surveillance to detect dengue by serotype-specifi...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9071282/ https://www.ncbi.nlm.nih.gov/pubmed/33319249 http://dx.doi.org/10.1093/infdis/jiaa761 |
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author | López-Medina, Eduardo Biswal, Shibadas Saez-Llorens, Xavier Borja-Tabora, Charissa Bravo, Lulu Sirivichayakul, Chukiat Vargas, Luis Martinez Alera, Maria Theresa Velásquez, Hector Reynales, Humberto Rivera, Luis Watanaveeradej, Veerachai Rodriguez-Arenales, Edith Johana Yu, Delia Espinoza, Felix Dietze, Reynaldo Fernando, Lak Kumar Wickramasinghe, Pujitha Duarte Moreira, Edson Fernando, Asvini D Gunasekera, Dulanie Luz, Kleber da Cunha, Rivaldo Venâncio Tricou, Vianney Rauscher, Martina Liu, Mengya LeFevre, Inge Wallace, Derek Kosalaraksa, Pope Borkowski, Astrid |
author_facet | López-Medina, Eduardo Biswal, Shibadas Saez-Llorens, Xavier Borja-Tabora, Charissa Bravo, Lulu Sirivichayakul, Chukiat Vargas, Luis Martinez Alera, Maria Theresa Velásquez, Hector Reynales, Humberto Rivera, Luis Watanaveeradej, Veerachai Rodriguez-Arenales, Edith Johana Yu, Delia Espinoza, Felix Dietze, Reynaldo Fernando, Lak Kumar Wickramasinghe, Pujitha Duarte Moreira, Edson Fernando, Asvini D Gunasekera, Dulanie Luz, Kleber da Cunha, Rivaldo Venâncio Tricou, Vianney Rauscher, Martina Liu, Mengya LeFevre, Inge Wallace, Derek Kosalaraksa, Pope Borkowski, Astrid |
author_sort | López-Medina, Eduardo |
collection | PubMed |
description | BACKGROUND: Takeda’s dengue vaccine is under evaluation in an ongoing phase 3 efficacy study; we present a 2-year update. METHODS: Children (20 099, 4–16 years old) were randomized to receive 2 doses of TAK-003 or placebo 3 months apart and are under surveillance to detect dengue by serotype-specific RT-PCR. RESULTS: Cumulative efficacy against dengue approximately 27 months since first dose was 72.7% (95% confidence interval [CI], 67.1%–77.3%), including 67.0% (95% CI, 53.6%–76.5%) in dengue-naive and 89.2% (95% CI, 82.4%–93.3%) against hospitalized dengue. In the second year, decline in efficacy was observed (56.2%; 95% CI, 42.3%–66.8%) with the largest decline in 4–5 year olds (24.5%; 95% CI, −34.2% to 57.5%); efficacy was 60.6% (95% CI, 43.8%–72.4%) in 6–11 year and 71.2% (95% CI, 41.0%–85.9%) in 12–16 year age groups. As TAK-003 efficacy varies by serotype, changes in serotype dominance partially contributed to efficacy differences in year-by-year analysis. No related serious adverse events occurred during the second year. CONCLUSIONS: TAK-003 demonstrated continued benefit independent of baseline serostatus in reducing dengue with some decline in efficacy during the second year. Three-year data will be important to see if efficacy stabilizes or declines further. Clinical Trials Registration. NCT02747927. Takeda’s tetravalent dengue vaccine (TAK-003) continued to demonstrate benefit in reducing dengue independent of baseline serostatus up to 2 years after completing vaccination with some decline in efficacy during the second year in 4–16 year olds in dengue-endemic countries. |
format | Online Article Text |
id | pubmed-9071282 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-90712822022-05-06 Efficacy of a Dengue Vaccine Candidate (TAK-003) in Healthy Children and Adolescents 2 Years after Vaccination López-Medina, Eduardo Biswal, Shibadas Saez-Llorens, Xavier Borja-Tabora, Charissa Bravo, Lulu Sirivichayakul, Chukiat Vargas, Luis Martinez Alera, Maria Theresa Velásquez, Hector Reynales, Humberto Rivera, Luis Watanaveeradej, Veerachai Rodriguez-Arenales, Edith Johana Yu, Delia Espinoza, Felix Dietze, Reynaldo Fernando, Lak Kumar Wickramasinghe, Pujitha Duarte Moreira, Edson Fernando, Asvini D Gunasekera, Dulanie Luz, Kleber da Cunha, Rivaldo Venâncio Tricou, Vianney Rauscher, Martina Liu, Mengya LeFevre, Inge Wallace, Derek Kosalaraksa, Pope Borkowski, Astrid J Infect Dis Major Articles and Brief Reports BACKGROUND: Takeda’s dengue vaccine is under evaluation in an ongoing phase 3 efficacy study; we present a 2-year update. METHODS: Children (20 099, 4–16 years old) were randomized to receive 2 doses of TAK-003 or placebo 3 months apart and are under surveillance to detect dengue by serotype-specific RT-PCR. RESULTS: Cumulative efficacy against dengue approximately 27 months since first dose was 72.7% (95% confidence interval [CI], 67.1%–77.3%), including 67.0% (95% CI, 53.6%–76.5%) in dengue-naive and 89.2% (95% CI, 82.4%–93.3%) against hospitalized dengue. In the second year, decline in efficacy was observed (56.2%; 95% CI, 42.3%–66.8%) with the largest decline in 4–5 year olds (24.5%; 95% CI, −34.2% to 57.5%); efficacy was 60.6% (95% CI, 43.8%–72.4%) in 6–11 year and 71.2% (95% CI, 41.0%–85.9%) in 12–16 year age groups. As TAK-003 efficacy varies by serotype, changes in serotype dominance partially contributed to efficacy differences in year-by-year analysis. No related serious adverse events occurred during the second year. CONCLUSIONS: TAK-003 demonstrated continued benefit independent of baseline serostatus in reducing dengue with some decline in efficacy during the second year. Three-year data will be important to see if efficacy stabilizes or declines further. Clinical Trials Registration. NCT02747927. Takeda’s tetravalent dengue vaccine (TAK-003) continued to demonstrate benefit in reducing dengue independent of baseline serostatus up to 2 years after completing vaccination with some decline in efficacy during the second year in 4–16 year olds in dengue-endemic countries. Oxford University Press 2020-12-15 /pmc/articles/PMC9071282/ /pubmed/33319249 http://dx.doi.org/10.1093/infdis/jiaa761 Text en © The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Major Articles and Brief Reports López-Medina, Eduardo Biswal, Shibadas Saez-Llorens, Xavier Borja-Tabora, Charissa Bravo, Lulu Sirivichayakul, Chukiat Vargas, Luis Martinez Alera, Maria Theresa Velásquez, Hector Reynales, Humberto Rivera, Luis Watanaveeradej, Veerachai Rodriguez-Arenales, Edith Johana Yu, Delia Espinoza, Felix Dietze, Reynaldo Fernando, Lak Kumar Wickramasinghe, Pujitha Duarte Moreira, Edson Fernando, Asvini D Gunasekera, Dulanie Luz, Kleber da Cunha, Rivaldo Venâncio Tricou, Vianney Rauscher, Martina Liu, Mengya LeFevre, Inge Wallace, Derek Kosalaraksa, Pope Borkowski, Astrid Efficacy of a Dengue Vaccine Candidate (TAK-003) in Healthy Children and Adolescents 2 Years after Vaccination |
title | Efficacy of a Dengue Vaccine Candidate (TAK-003) in Healthy Children and Adolescents 2 Years after Vaccination |
title_full | Efficacy of a Dengue Vaccine Candidate (TAK-003) in Healthy Children and Adolescents 2 Years after Vaccination |
title_fullStr | Efficacy of a Dengue Vaccine Candidate (TAK-003) in Healthy Children and Adolescents 2 Years after Vaccination |
title_full_unstemmed | Efficacy of a Dengue Vaccine Candidate (TAK-003) in Healthy Children and Adolescents 2 Years after Vaccination |
title_short | Efficacy of a Dengue Vaccine Candidate (TAK-003) in Healthy Children and Adolescents 2 Years after Vaccination |
title_sort | efficacy of a dengue vaccine candidate (tak-003) in healthy children and adolescents 2 years after vaccination |
topic | Major Articles and Brief Reports |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9071282/ https://www.ncbi.nlm.nih.gov/pubmed/33319249 http://dx.doi.org/10.1093/infdis/jiaa761 |
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