Efficacy and Safety of a Tetravalent Dengue Vaccine (TAK-003) in Children With Prior Japanese Encephalitis or Yellow Fever Vaccination
Chukiat Sirivichayakul, Shibadas Biswal, Xavier Saez-Llorens, Eduardo López-Medina, Charissa Borja-Tabora, Lulu Bravo, Pope Kosalaraksa, Maria Theresa Alera, Humberto Reynales, Luis Rivera, Veerachai Watanaveeradej, Delia Yu, Felix Espinoza, Reynaldo Dietze, LakKumar Fernando, V Pujitha Wickramasinghe, Edson Duarte Moreira, Asvini D Fernando, Dulanie Gunasekera, Kleber Luz, Rivaldo Venâncio da Cunha, Ana Lucia Oliveira, Martina Rauscher, Huihao Fan, Astrid Borkowski, Ian Escudero, Suely Tuboi, Eric Lloyd, Vianney Tricou, Nicolas Folschweiller, Inge LeFevre, Luis Martinez Vargas, Derek Wallace, Asvini Fernando, Charissa Borja-Tabora, Chukiat Sirivichayakul, Delia Yu, Dulanie Gunasekera, Eduardo López-Medina, Edith Johanna Rodriguez-Arenales, Edson Duarte Moreira, Felix Espinoza, Hector Velásquez, Humberto Reynales, Kleber Luz, Jose Jimeno, Rodrigo deAntonio, Elaine Aranguren, LakKumar Fernando, Lulu Bravo, Luis Martinez Vargas, Luis Rivera, Maria Theresa Alera, Onanong Manacharoen, Pio Lopez, Pope Kosalaraksa, V Pujitha Wickramasinghe, Reynaldo Dietze, Rivaldo Venâncio da Cunha, Veerachai Watanaveeradej, Xavier Saez-Llorens, Shibadas Biswal, Manja Brose, Martina Rauscher, Olaf Zent, Mengya Liu, Elaine Hoffman, Inge LeFevre, Astrid Borkowski, Derek Wallace, Ian Escudero, Ivo Sonderegger, Yanee Hutagalung, Suely Tuboi, Vianney Tricou,Abstract
Background
We explored the impact of prior Yellow fever (YF) or Japanese encephalitis (JE) vaccination on the efficacy of Takeda’s dengue vaccine candidate, TAK-003 (NCT02747927).
Methods
Children 4–16 years of age were randomized 2:1 to receive TAK-003 or placebo and were under active febrile surveillance. Symptomatic dengue was confirmed by serotype-specific RT-PCR. YF and JE vaccination history was recorded.
Results
Of the 20,071 children who received TAK-003 or placebo, 21.1% had a YF and 23.9% had a JE vaccination history at randomization. Fifty-seven months after vaccination, vaccine efficacy was 55.7% (95% CI, 39.7%-67.5%) in those with YF vaccination, 77.8% (70.8%-83.1%) for JE vaccination, and 53.5% (45.4%-60.4%) for no prior YF/JE vaccination. Regional differences in serotype distribution confound these results. The apparent higher vaccine efficacy in the JE vaccination subgroup could be largely explained by serotype-specific efficacy of TAK-003. Within 28 days of any vaccination, the proportions of participants with serious adverse events in the YF/JE prior vaccination population were comparable between the TAK-003 and placebo groups.
Conclusions
The available data do not suggest a clinically relevant impact of prior JE or YF vaccination on TAK-003 performance. Overall, TAK-003 was well-tolerated and efficacious in different epidemiological settings.