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 | pt_BR |
Abstract | 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. | pt_BR |