Efficacy of a Tetravalent Dengue Vaccine in Healthy Children and Adolescents
| Autor: | Shibadas, Biswal, Humberto, Reynales, Xavier, Saez-Llorens, Pio, Lopez, Charissa, Borja-Tabora, Pope, Kosalaraksa, Chukiat, Sirivichayakul, Veerachai, Watanaveeradej, Luis, Rivera, Felix, Espinoza, LakKumar, Fernando, Reynaldo, Dietze, Kleber, Luz, Rivaldo, Venâncio da Cunha, José, Jimeno, Eduardo, López-Medina, Astrid, Borkowski, Manja, Brose, Martina, Rauscher, Inge, LeFevre, Svetlana, Bizjajeva, Lulu, Bravo, Derek, Wallace, Zenaida, Mojares |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Male
Asia Adolescent Endemic Diseases Dengue Vaccines 030204 cardiovascular system & hematology Antibodies Viral Serogroup World health law.invention Dengue fever Dengue 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial law Environmental health Global health Humans Medicine 030212 general & internal medicine Child Dengue vaccine business.industry Incidence Incidence (epidemiology) General Medicine Dengue Virus medicine.disease Antibodies Neutralizing Clinical trial Treatment Outcome Child Preschool Female Viral disease Americas business |
| Zdroj: | New England Journal of Medicine. 381:2009-2019 |
| ISSN: | 1533-4406 0028-4793 |
| Popis: | Dengue, a mosquito-borne viral disease, was designated a World Health Organization top 10 threat to global health in 2019.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.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).TAK-003 was efficacious against symptomatic dengue in countries in which the disease is endemic. (Funded by Takeda Vaccines; TIDES ClinicalTrials.gov number, NCT02747927.). |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|