PMID- 34131423
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220423
IS  - 1680-5348 (Electronic)
IS  - 1020-4989 (Print)
IS  - 1020-4989 (Linking)
VI  - 45
DP  - 2021
TI  - Immunogenicity and safety of a tetravalent dengue vaccine in dengue-naive 
      adolescents in Mexico City.
PG  - e67
LID - 10.26633/RPSP.2021.67 [doi]
LID - e67
AB  - OBJECTIVE: To describe the immunogenicity and safety of a tetravalent dengue 
      vaccine (TAK-003) in healthy adolescents living in Mexico City, an area 
      considered non-endemic for dengue (NCT03341637). METHODS: Participants aged 12-17 
      years were randomized 3:1 to receive two doses (Month 0 and Month 3) of TAK-003 
      or placebo. Immunogenicity was assessed by microneutralization assay of dengue 
      neutralizing antibodies at baseline, Months 4 and 9. Solicited and unsolicited 
      adverse events (AEs) were recorded after each vaccination. Serious (SAEs) and 
      medically-attended AEs (MAAEs) were recorded throughout the study. RESULTS: 400 
      adolescents were enrolled, 391 (97.8%) completed the study. Thirty-six (9%) were 
      baseline seropositive to >/=1 serotypes (reciprocal titer >/=10). Geometric mean 
      titers (GMTs) in baseline seronegative TAK-003 recipients were 328, 1743, 120, 
      and 143 at Month 4, and 135, 741, 46, and 38 at Month 9 against DENV-1, -2, -3, 
      and -4, respectively. Placebo GMTs remained <10. Tetravalent seropositivity rates 
      in vaccine recipients were 99.6% and 85.8% at Months 4 and 9, respectively. One 
      MAAE in each group was considered treatment-related (TAK-003: injection-site 
      erythema, and placebo: pharyngitis). CONCLUSION: TAK-003 was immunogenic against 
      all four serotypes and was well tolerated in dengue-naive adolescents living in 
      Mexico City.
FAU - Biswal, Shibadas
AU  - Biswal S
AD  - Takeda Vaccines Inc. Boston United States of America Takeda Vaccines Inc., 
      Boston, United States of America.
FAU - Mendez Galvan, Jorge Fernando
AU  - Mendez Galvan JF
AD  - Hospital Infantil de Mexico Federico Gomez Mexico City Mexico Hospital Infantil 
      de Mexico Federico Gomez, Mexico City, Mexico.
FAU - Macias Parra, Mercedes
AU  - Macias Parra M
AD  - Instituto Nacional de Pediatria Mexico City Mexico Instituto Nacional de 
      Pediatria, Mexico City, Mexico.
FAU - Galan-Herrera, Juan-Francisco
AU  - Galan-Herrera JF
AD  - Instituto Politecnico Nacional Mexico City Mexico Instituto Politecnico Nacional, 
      Mexico City, Mexico.
FAU - Carrascal Rodriguez, Monica Belisa
AU  - Carrascal Rodriguez MB
AD  - CAIMED Investigacion en Salud Mexico City Mexico CAIMED Investigacion en Salud, 
      Mexico City, Mexico.
FAU - Rodriguez Bueno, Esteban Patricio
AU  - Rodriguez Bueno EP
AD  - Mexico Center for Clinical Research Mexico City Mexico Mexico Center for Clinical 
      Research, Mexico City, Mexico.
FAU - Brose, Manja
AU  - Brose M
AD  - Takeda Pharmaceuticals International AG. Zurich Switzerland Takeda 
      Pharmaceuticals International AG., Zurich, Switzerland.
FAU - Rauscher, Martina
AU  - Rauscher M
AD  - Takeda Pharmaceuticals International AG. Zurich Switzerland Takeda 
      Pharmaceuticals International AG., Zurich, Switzerland.
FAU - LeFevre, Inge
AU  - LeFevre I
AD  - Takeda Pharmaceuticals International AG. Zurich Switzerland Takeda 
      Pharmaceuticals International AG., Zurich, Switzerland.
FAU - Wallace, Derek
AU  - Wallace D
AD  - Takeda Vaccines Inc. Boston United States of America Takeda Vaccines Inc., 
      Boston, United States of America.
FAU - Borkowski, Astrid
AU  - Borkowski A
AD  - Takeda Pharmaceuticals International AG. Zurich Switzerland Takeda 
      Pharmaceuticals International AG., Zurich, Switzerland.
LA  - eng
SI  - ClinicalTrials.gov/NCT03341637
PT  - Journal Article
DEP - 20210611
PL  - United States
TA  - Rev Panam Salud Publica
JT  - Revista panamericana de salud publica = Pan American journal of public health
JID - 9705400
PMC - PMC8196333
OTO - NOTNLM
OT  - Mexico
OT  - Vaccines
OT  - adolescents
OT  - dengue
OT  - immunogenicity
OT  - safety
EDAT- 2021/06/17 06:00
MHDA- 2021/06/17 06:01
PMCR- 2021/06/11
CRDT- 2021/06/16 06:47
PHST- 2020/12/18 00:00 [received]
PHST- 2021/03/12 00:00 [accepted]
PHST- 2021/06/16 06:47 [entrez]
PHST- 2021/06/17 06:00 [pubmed]
PHST- 2021/06/17 06:01 [medline]
PHST- 2021/06/11 00:00 [pmc-release]
AID - RPSP.2021.67 [pii]
AID - 10.26633/RPSP.2021.67 [doi]
PST - epublish
SO  - Rev Panam Salud Publica. 2021 Jun 11;45:e67. doi: 10.26633/RPSP.2021.67. 
      eCollection 2021.