Chukiat Sirivichayakul1, Elizabeth A Barranco-Santana2, Inés Esquilin-Rivera3, Helen M L Oh4, Marsha Raanan5, Carlos A Sariol6, Lynette P Shek7, Sriluck Simasathien8, Mary Kathryn Smith5, Ivan Dario Velez9, Derek Wallace10, Gilad S Gordon11, Dan T Stinchcomb5. 1. Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University. 2. CAIMED Center, Ponce School of Medicine. 3. Department of Pediatrics. 4. Division of Infectious Disease, Changi General Hospital. 5. Takeda Vaccines, Inc., Deerfield, Illinois. 6. Department of Microbiology and Medical Zoology Department of Internal Medicine, University of Puerto Rico School of Medicine Latin Clinical Trial Center, San Juan, Puerto Rico. 7. Department of Paediatrics, National University of Singapore. 8. Pediatric Department, Phramongkutklao Hospital, Bangkok, Thailand. 9. Program for the Study and Control of Tropical Diseases, Universidad de Antioquia, Medellín, Colombia. 10. Takeda Vaccines Pte. Ltd., Singapore. 11. Orra Group, Boulder, Colorado.
Abstract
BACKGROUND: A safe, effective tetravalent dengue vaccine is a global health priority. The safety and immunogenicity of a live attenuated, recombinant tetravalent dengue vaccine candidate (TDV) were evaluated in healthy volunteers from dengue-endemic countries. METHODS: This multicenter, double-blind, phase 2 study was conducted in Puerto Rico, Colombia, Singapore, and Thailand. During stage I, 148 volunteers aged 1.5-45 years were sequentially enrolled into 4 age-descending groups and randomized at a ratio of 2:1 to receive TDV or placebo. In stage II (group 5), 212 children aged 1.5-11 years were randomized at a ratio of 3:1 to receive TDV or placebo. Participants received a subcutaneous injection of TDV or placebo on days 0 and 90 and were followed for analysis of safety, seropositivity, and neutralizing antibodies to DENV-1-4. RESULTS:Injection site pain, itching, and erythema (mostly mild) were the only solicited adverse events more frequently reported with TDV than with placebo in all age groups. After 2 TDV doses, seropositivity was >95% in all 5 groups for DENV-1-3 and 72.7%-100% for DENV-4; geometric mean titers ranged from 582 to 1187 for DENV-1, from 582 to 1187 for DENV-2, from 196 to 630 for DENV-3, and from 41 to 210 for DENV-4 among the 5 groups. CONCLUSIONS:TDV was well tolerated and immunogenic in volunteers aged 1.5-45 years, irrespective of prevaccination dengue exposure.
RCT Entities:
BACKGROUND: A safe, effective tetravalent dengue vaccine is a global health priority. The safety and immunogenicity of a live attenuated, recombinant tetravalent dengue vaccine candidate (TDV) were evaluated in healthy volunteers from dengue-endemic countries. METHODS: This multicenter, double-blind, phase 2 study was conducted in Puerto Rico, Colombia, Singapore, and Thailand. During stage I, 148 volunteers aged 1.5-45 years were sequentially enrolled into 4 age-descending groups and randomized at a ratio of 2:1 to receive TDV or placebo. In stage II (group 5), 212 children aged 1.5-11 years were randomized at a ratio of 3:1 to receive TDV or placebo. Participants received a subcutaneous injection of TDV or placebo on days 0 and 90 and were followed for analysis of safety, seropositivity, and neutralizing antibodies to DENV-1-4. RESULTS: Injection site pain, itching, and erythema (mostly mild) were the only solicited adverse events more frequently reported with TDV than with placebo in all age groups. After 2 TDV doses, seropositivity was >95% in all 5 groups for DENV-1-3 and 72.7%-100% for DENV-4; geometric mean titers ranged from 582 to 1187 for DENV-1, from 582 to 1187 for DENV-2, from 196 to 630 for DENV-3, and from 41 to 210 for DENV-4 among the 5 groups. CONCLUSIONS:TDV was well tolerated and immunogenic in volunteers aged 1.5-45 years, irrespective of prevaccination dengue exposure.
Authors: Jesica A Swanstrom; Sandra Henein; Jessica A Plante; Boyd L Yount; Douglas G Widman; Emily N Gallichotte; Hansi J Dean; Jorge E Osorio; Charalambos D Partidos; Aravinda M de Silva; Ralph S Baric Journal: J Infect Dis Date: 2018-05-25 Impact factor: 5.226
Authors: Robert K M Choy; A Louis Bourgeois; Christian F Ockenhouse; Richard I Walker; Rebecca L Sheets; Jorge Flores Journal: Clin Microbiol Rev Date: 2022-07-06 Impact factor: 50.129
Authors: Neil M Ferguson; Isabel Rodríguez-Barraquer; Ilaria Dorigatti; Luis Mier-Y-Teran-Romero; Daniel J Laydon; Derek A T Cummings Journal: Science Date: 2016-09-02 Impact factor: 47.728
Authors: Michael K McCracken; Caitlin H Kuklis; Chandrika B Kannadka; David A Barvir; Mark A Sanborn; Adam T Waickman; Hayden C Siegfried; Kaitlin A Victor; Kristin L Hatch; Rafael De La Barrera; Shannon D Walls; Wiriya Rutvisuttinunt; Jeffrey R Currier; Heather Friberg; Richard G Jarman; Gregory D Gromowski Journal: NPJ Vaccines Date: 2021-05-21 Impact factor: 7.344