Immunogenicity and safety of a recombinant tetravalent dengue vaccine in children and adolescents ages 9-16 years in Brazil

Gustavo H Dayan, Pedro Garbes, Fernando Noriega, Ana Daniela Izoton de Sadovsky, Patricia Marques Rodrigues, Camila Giuberti, Reynaldo Dietze, Gustavo H Dayan, Pedro Garbes, Fernando Noriega, Ana Daniela Izoton de Sadovsky, Patricia Marques Rodrigues, Camila Giuberti, Reynaldo Dietze

Abstract

Immunogenicity and safety of a recombinant, live-attenuated, tetravalent dengue disease vaccine (CYD-TDV) was evaluated in children/adolescents in Brazil. In this observer-blind, placebo-controlled, phase II single-center study, children/adolescents (ages 9-16 years) were randomized to receive CYD-TDV or placebo at 0, 6, and 12 months. Immunogenicity was assessed using a 50% plaque neutralization test. Overall, 150 participants were enrolled (CYD-TDV: N = 100; placebo: N = 50). Injection site pain and headache were the most common solicited injection site and systemic reactions. Unsolicited adverse events (AEs) and serious AEs were similar between groups. No serious AEs were vaccine-related. Geometric mean titers against all dengue virus serotypes increased with CYD-TDV vaccination and were 267, 544, 741, and 432 1/dil for serotypes 1-4, respectively, after dose 3, representing a mean fold increase from baseline of 5, 6, 6, and 20, respectively. CYD-TDV vaccination elicited a neutralizing antibody response against serotypes 1-4 and was well-tolerated in children/adolescents in a dengue-endemic region.

Figures

Figure 1.
Figure 1.
Study flow chart: progress of participants through the trial.
Figure 2.
Figure 2.
Proportion of participants with different categories of AEs after each vaccine dose by vaccine group and FV seropositivity status at baseline.
Figure 3.
Figure 3.
Dengue serotype-specific GMTs of antibodies at baseline and 28 days after each dose of CYD-TDV according to whether participants were flavivirus seropositive (N = 80) or seronegative (N = 19) at baseline.

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Source: PubMed

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