Abstract | BACKGROUND: The efficacy of the recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV) against virologically-confirmed dengue (VCD) has been documented in a phase 3 trial in Latin America (CYD15, NCT01374516). This is a descriptive secondary analysis of the efficacy and safety of CYD-TDV in participants from Colombia. METHODS: Data from 9740 Colombian participants 9-16 years of age who were randomized 2:1 to receive CYD-TDV or placebo were assessed to describe the vaccine efficacy of CYD-TDV against VCD and severe VCD. Estimation was made of the relative risk (RR) for hospitalized VCD cases and severe hospitalized VCD cases after the first dose of CYD-TDV, as well as a description of the incidence of hospitalized dengue from the start of the study and per year of the study until study completion. RESULTS: During the active phase of the trial in Colombia, the efficacy of CYD-TDV was 67.5% [95% confidence interval (CI): 58.3-74.7] against symptomatic VCD due to any serotype from injection 1 (month 0) to 25 months postinjection 1. Over 6 years, the RR across all 4 serotypes was 0.166 (95% CI: 0.09-0.29) in hospitalized VCD patients and 0.154 (95% CI: 0.04-0.50) in patients with severe hospitalized VCD. CONCLUSIONS: Analysis of the data from Colombia mimics the efficacy observed in CYD15 during the active surveillance follow-up (25 months), but with a sustained beneficial RR for dengue hospitalizations on the subsequent years of follow-up. In Colombia, where seroprevalence has been demonstrated to be high in several regions of the country, CYD-TDV is a useful tool to consider as part of an integrated control strategy against endemic dengue, a disease with a high economic impact on the health system.
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Authors | Humberto Reynales, Gabriel Carrasquilla, Betzana Zambrano, Margarita Cortés S, Tifany Machabert, Jin Jing, Sophie Pallardy, Owen Haney, Martha Faccini, Juliana Quintero, Fernando Noriega |
Journal | The Pediatric infectious disease journal
(Pediatr Infect Dis J)
Vol. 39
Issue 4
Pg. e30-e36
(04 2020)
ISSN: 1532-0987 [Electronic] United States |
PMID | 32040014
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Neutralizing
- Antibodies, Viral
- Dengue Vaccines
- Vaccines, Attenuated
- Vaccines, Synthetic
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Topics |
- Adolescent
- Antibodies, Neutralizing
(blood)
- Antibodies, Viral
(blood)
- Child
- Colombia
- Dengue
(prevention & control)
- Dengue Vaccines
(administration & dosage, immunology)
- Dengue Virus
- Female
- Hospitalization
(statistics & numerical data)
- Humans
- Immunogenicity, Vaccine
- Incidence
- Male
- Serogroup
- Severe Dengue
(prevention & control)
- Vaccination
(statistics & numerical data)
- Vaccines, Attenuated
(administration & dosage, immunology)
- Vaccines, Synthetic
(administration & dosage, immunology)
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