Tetravalent Dengue Vaccine Reduces Symptomatic and Asymptomatic Dengue Virus Infections in Healthy Children and Adolescents Aged 2–16 Years in Asia and Latin America

December 11, 2016 at 4:49 pm

Journal of Infectious Diseases October 1, 2016 V.214 N.7 P.994-1000

Gustavo Olivera-Botello, Laurent Coudeville, Karen Fanouillere, Bruno Guy, Laurent Chambonneau, Fernando Noriega, and Nicholas Jackson for the CYD-TDV Vaccine Trial Group

1Sanofi Pasteur, Lyon

2Sanofi, Chilly-Mazarin Cedex

3Sanofi Pasteur, Marcy l’Etoile, France

4Sanofi Pasteur, Swiftwater, Pennsylvania

Background

Asymptomatic dengue virus–infected individuals are thought to play a major role in dengue virus transmission. The efficacy of the recently approved quadrivalent CYD-TDV dengue vaccine against asymptomatic dengue virus infection has not been previously assessed.

Methods

We pooled data for 3 736 individuals who received either CYD-TDV or placebo at 0, 6, and 12 months in the immunogenicity subsets of 2 phase 3 trials (clinical trials registration NCT01373281 and NCT01374516). We defined a seroconversion algorithm (ie, a ≥4-fold increase in the neutralizing antibody titer and a titer of ≥40 from month 13 to month 25) as a surrogate marker of asymptomatic infection in the vaccine and placebo groups.

Results

The algorithm detected seroconversion in 94% of individuals with a diagnosis of virologically confirmed dengue between months 13 and 25, validating its discriminatory power. Among those without virologically confirmed dengue (n = 3 669), 219 of 2 485 in the vaccine group and 157 of 1 184 in the placebo group seroconverted between months 13 and 25, giving a vaccine efficacy of 33.5% (95% confidence interval [CI], 17.9%–46.1%) against asymptomatic infection. Vaccine efficacy was marginally higher in subjects aged 9–16 years (38.6%; 95% CI, 22.1%–51.5%). The annual incidence of asymptomatic dengue virus infection in this age group was 14.8%, which was 4.4 times higher than the incidence for symptomatic dengue (3.4%).

Conclusions

The observed vaccine efficacy against asymptomatic dengue virus infections is expected to translate into reduced dengue virus transmission if sufficient individuals are vaccinated in dengue-endemic areas.

PDF

http://jid.oxfordjournals.org/content/214/7/994.full.pdf+html

 

Entry filed under: Infecciones emergentes, Infecciones virales, Inmunizaciones, Medicina del viajero, Update. Tags: .

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