Efficacy of a Tetravalent Dengue Vaccine in Healthy Children and Adolescents

November 21, 2019 at 8:05 am

NEJM November 21, 219 V.381 P.2009-2019

Shibadas Biswal, M.D., Humberto Reynales, M.D., Ph.D., Xavier Saez-Llorens, M.D., Pio Lopez, M.D., Charissa Borja-Tabora, M.D., Pope Kosalaraksa, M.D., Chukiat Sirivichayakul, M.D., Veerachai Watanaveeradej, M.D., Luis Rivera, M.D., Felix Espinoza, M.D., LakKumar Fernando, M.D., Reynaldo Dietze, M.D., et al., for the TIDES Study Group*

BACKGROUND

Dengue, a mosquito-borne viral disease, was designated a World Health Organization top 10 threat to global health in 2019.

METHODS

We present primary efficacy data from part 1 of an ongoing phase 3 randomized trial of a tetravalent dengue vaccine candidate (TAK-003) in regions of Asia and Latin America in which the disease is endemic. Healthy children and adolescents 4 to 16 years of age were randomly assigned in a 2:1 ratio (stratified according to age category and region) to receive two doses of vaccine or placebo 3 months apart. Participants presenting with febrile illness were tested for virologically confirmed dengue by serotype-specific reverse-transcriptase polymerase chain reaction. The primary end point was overall vaccine efficacy in preventing virologically confirmed dengue caused by any dengue virus serotype.

RESULTS

Of the 20,071 participants who were given at least one dose of vaccine or placebo (safety population), 19,021 (94.8%) received both injections and were included in the per-protocol analysis. The overall vaccine efficacy in the safety population was 80.9% (95% confidence interval [CI], 75.2 to 85.3; 78 cases per 13,380 [0.5 per 100 person-years] in the vaccine group vs. 199 cases per 6687 [2.5 per 100 person-years] in the placebo group). In the per-protocol analyses, vaccine efficacy was 80.2% (95% CI, 73.3 to 85.3; 61 cases of virologically confirmed dengue in the vaccine group vs. 149 cases in the placebo group), with 95.4% efficacy against dengue leading to hospitalization (95% CI, 88.4 to 98.2; 5 hospitalizations in the vaccine group vs. 53 hospitalizations in the placebo group). Planned exploratory analyses involving the 27.7% of the per-protocol population that was seronegative at baseline showed vaccine efficacy of 74.9% (95% CI, 57.0 to 85.4; 20 cases of virologically confirmed dengue in the vaccine group vs. 39 cases in the placebo group). Efficacy trends varied according to serotype. The incidence of serious adverse events was similar in the vaccine group and placebo group (3.1% and 3.8%, respectively).

CONCLUSIONS

TAK-003 was efficacious against symptomatic dengue in countries in which the disease is endemic. (Funded by Takeda Vaccines; TIDES ClinicalTrials.gov number, NCT02747927. opens in new tab.)

FULL TEXT

https://www.nejm.org/doi/full/10.1056/NEJMoa1903869?query=TOC

PDF

https://www.nejm.org/doi/pdf/10.1056/NEJMoa1903869?articleTools=true

Entry filed under: Biología Molecular, Epidemiología, FIEBRE en el POST-VIAJE, FIEBRE y RASH, Infecciones emergentes, Infecciones virales, Inmunizaciones, Medicina del viajero, Metodos diagnosticos, REPORTS, Sepsis, Update.

2019-11 Hospital-Acquired Infections in New York State, 2018 –  N York State Department of Health 24 Pags Perspective – Eastern Equine Encephalitis Virus — Another Emergent Arbovirus in the United States


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