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

ABSTRACT:

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 m

SUBMITTER: Biswal S 

PROVIDER: S-EPMC8196333 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature