BACKGROUND: Preliminary results in healthy, young US adults showed that a tetravalent, live-attenuated dengue vaccine (TDV) was safe and immunogenic, but no data are available in children. METHODS: In a multicenter, randomized, controlled, observer-blinded study in the city of Mexico, children aged 2 to 5, 6 to 11, and 12 to 17 years (36 children per age group), and adults (n = 18) aged <45 years received the following: 3 injections of TDV at months 0, 3.5, and 12 (TDV-TDV-TDV), or 1 injection of yellow fever vaccine (YF) at month 0, and 2 injections of TDV at months 3.5 and 12 (YF-TDV-TDV). Adverse events and biologic safety (biochemistry and hematology) were documented. Plaque reduction neutralization test (PRNT50) antibody titers against the TDV parental viruses were measured 28 days after vaccination. Seropositivity was defined as antibody titers ≥10 1/dil. RESULTS: No vaccine-related serious adverse events, other significant clinical adverse events, or clinically significant trends in biologic safety were observed. Reactogenicity did not increase with successive TDV injections, and mild-to-moderate injection site pain, headache, myalgia, and malaise were most commonly reported (14%-40% after each vaccination). After 3 TDV vaccinations, the seropositivity rate against each dengue serotype was in the range 77% to 92%, compared with 85% to 94% after completion of the YF-TDV-TDV regimen. Of the 2- to 11-year-old participants, 95% were seropositive against ≥3 serotypes after 3 vaccinations. CONCLUSIONS: A 3-dose TDV regimen had a favorable safety profile in children and adults and elicited neutralizing antibody responses against all 4 serotypes. These findings support the continued development of this vaccine.
RCT Entities:
BACKGROUND: Preliminary results in healthy, young US adults showed that a tetravalent, live-attenuated dengue vaccine (TDV) was safe and immunogenic, but no data are available in children. METHODS: In a multicenter, randomized, controlled, observer-blinded study in the city of Mexico, children aged 2 to 5, 6 to 11, and 12 to 17 years (36 children per age group), and adults (n = 18) aged <45 years received the following: 3 injections of TDV at months 0, 3.5, and 12 (TDV-TDV-TDV), or 1 injection of yellow fever vaccine (YF) at month 0, and 2 injections of TDV at months 3.5 and 12 (YF-TDV-TDV). Adverse events and biologic safety (biochemistry and hematology) were documented. Plaque reduction neutralization test (PRNT50) antibody titers against the TDV parental viruses were measured 28 days after vaccination. Seropositivity was defined as antibody titers ≥10 1/dil. RESULTS: No vaccine-related serious adverse events, other significant clinical adverse events, or clinically significant trends in biologic safety were observed. Reactogenicity did not increase with successive TDV injections, and mild-to-moderate injection site pain, headache, myalgia, and malaise were most commonly reported (14%-40% after each vaccination). After 3 TDV vaccinations, the seropositivity rate against each dengue serotype was in the range 77% to 92%, compared with 85% to 94% after completion of the YF-TDV-TDV regimen. Of the 2- to 11-year-old participants, 95% were seropositive against ≥3 serotypes after 3 vaccinations. CONCLUSIONS: A 3-dose TDV regimen had a favorable safety profile in children and adults and elicited neutralizing antibody responses against all 4 serotypes. These findings support the continued development of this vaccine.
Authors: Anke Harenberg; Sarah Begue; Audrey Mamessier; Sophie Gimenez-Fourage; Ching Ching Seah; Ai Wei Liang; Jun Li Ng; Xue Yun Toh; Sophia Archuleta; Annelies Wilder-Smith; Lynette P Shek; Anh Wartel-Tram; Alain Bouckenooghe; Jean Lang; Denis Crevat; Catherine Caillet; Bruno Guy Journal: Hum Vaccin Immunother Date: 2013-07-09 Impact factor: 3.452
Authors: Anna P Durbin; Beth D Kirkpatrick; Kristen K Pierce; Daniel Elwood; Catherine J Larsson; Janet C Lindow; Cecilia Tibery; Beulah P Sabundayo; Donna Shaffer; Kawsar R Talaat; Noreen A Hynes; Kimberli Wanionek; Marya P Carmolli; Catherine J Luke; Brian R Murphy; Kanta Subbarao; Stephen S Whitehead Journal: J Infect Dis Date: 2013-01-17 Impact factor: 5.226
Authors: Joshua M Costin; Elena Zaitseva; Kristen M Kahle; Cindo O Nicholson; Dawne K Rowe; Amanda S Graham; Lindsey E Bazzone; Greg Hogancamp; Marielys Figueroa Sierra; Rachel H Fong; Sung-Tae Yang; Li Lin; James E Robinson; Benjamin J Doranz; Leonid V Chernomordik; Scott F Michael; John S Schieffelin; Sharon Isern Journal: J Virol Date: 2012-10-17 Impact factor: 5.103
Authors: Jorge E Osorio; Ivan D Velez; Cynthia Thomson; Liliana Lopez; Alejandra Jimenez; Aurelia A Haller; Shawn Silengo; Jaclyn Scott; Karen L Boroughs; Janae L Stovall; Betty E Luy; John Arguello; Mark E Beatty; Joseph Santangelo; Gilad S Gordon; Claire Y-H Huang; Dan T Stinchcomb Journal: Lancet Infect Dis Date: 2014-07-23 Impact factor: 25.071