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. 2018 Jul;24(7):755-763.
doi: 10.1016/j.cmi.2018.01.018. Epub 2018 Feb 8.

Four-year safety follow-up of the tetravalent dengue vaccine efficacy randomized controlled trials in Asia and Latin America

J L Arredondo-García  1 , S R Hadinegoro  2 , H Reynales  3 , M N Chua  4 , D M Rivera Medina  5 , T Chotpitayasunondh  6 , N H Tran  7 , C C Deseda  8 , D N Wirawan  9 , M Cortés Supelano  10 , C Frago  11 , E Langevin  12 , D Coronel  13 , T Laot  14 , A P Perroud  15 , L Sanchez  14 , M Bonaparte  16 , K Limkittikul  17 , D Chansinghakul  18 , S Gailhardou  19 , F Noriega  16 , T A Wartel  12 , A Bouckenooghe  11 , B Zambrano  20 ; CYD-TDV Dengue Vaccine Study Group
Affiliations
Free article

Four-year safety follow-up of the tetravalent dengue vaccine efficacy randomized controlled trials in Asia and Latin America

J L Arredondo-García et al. Clin Microbiol Infect. 2018 Jul.
Free article

Abstract

Objective: Our objective was to describe the risk of hospital admission for virologically confirmed dengue (VCD) and the risk of clinically severe hospitalized VCD occurring up to 4 years after the first dose (years 1 to 4) in three randomized clinical trials comparing tetravalent dengue vaccine with placebo.

Methods: The relative risks (RR) for hospitalized VCD from first dose to year 4 were estimated by year and age-group in individual and combined studies.

Results: Overall, from Year 1 to Year 4, 233 and 228 participants had at least one episode of hospitalized VCD in the vaccinated (n = 22 603) and placebo (n = 11 301) groups, respectively (RR = 0.511, 95% CI 0.42-0.62). Among these, 48 and 47 cases, respectively, were classified as clinically severe. In children aged ≥9 years, 88 and 136 participants had at least one episode of hospitalized VCD in the vaccinated (n = 17 629) and placebo (n = 8821) groups, respectively (RR = 0.324; 95% CI 0.24-0.43). In vaccinated participants aged <9 years, particularly in those aged 2-5 years, there were more hospitalized VCD cases compared with the control participants in Year 3 but not in Year 4. The overall RR in those aged <9 years for Year 1 to Year 4 was 0.786 (95% CI 0.60-1.03), with a higher protective effect in the 6-8 year olds than in the 2-5 year olds.

Conclusions: The overall benefit-risk remained positive in those aged ≥9 years up to year 4, although the protective effect was lower in years 3 and 4 than in years 1 and 2.

Keywords: Children; Dengue disease; Dengue vaccine; Long-term follow up; Vaccine safety.

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