Immunogenicity and safety of a tetravalent dengue vaccine in dengue-naïve adolescents in Mexico City

Autor: Shibadas Biswal, Jorge Fernando Mendez Galvan, Mercedes Macias Parra, Juan-Francisco Galan-Herrera, Monica Belisa Carrascal Rodriguez, Esteban Patricio Rodriguez Bueno, Manja Brose, Martina Rauscher, Inge LeFevre, Derek Wallace, Astrid Borkowski
Jazyk: English<br />Spanish; Castilian<br />Portuguese
Rok vydání: 2021
Předmět:
Zdroj: Revista Panamericana de Salud Pública, Vol 45, Iss 67, Pp 1-11 (2021)
Druh dokumentu: article
ISSN: 1020-4989
1680-5348
DOI: 10.26633/RPSP.2021.67
Popis: 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-naïve adolescents living in Mexico City.
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