Role of the dengue vaccine TAK-003 in an outbreak response: Modeling the Sri Lanka experience.

Background: Outbreaks of dengue can overburden hospital systems, drastically reducing capacity for other care. The 2017 dengue serotype 2 (DENV-2) outbreak in Sri Lanka coincided with vaccination in an ongoing phase 3 efficacy trial of a tetravalent dengue vaccine, TAK-003 (NCT02747927). Here, we present data on the efficacy of TAK-003 following two doses of the vaccine administered 3 months apart in participants aged 4-16 years in Sri Lanka.

Immunogenicity, safety, and efficacy of a tetravalent dengue vaccine in children and adolescents: an analysis by age group.

Background: Dengue is an increasing threat to global health. This exploratory analysis evaluated the immunogenicity, safety, and vaccine efficacy (VE) of a live-attenuated tetravalent dengue vaccine (TAK-003) in participants enrolled in the phase 3 DEN-301 trial (NCT02747927), stratified by baseline age (4-5 years; 6-11 years; or 12-16 years).

Methods: Participants were randomized 2:1 to receive 2 doses of TAK-003, administered 3 months apart, or placebo.

Effect of the Tetravalent Dengue Vaccine TAK-003 on Sequential Episodes of Symptomatic Dengue.

In the pivotal phase 3 efficacy trial (NCT02747927) of the TAK-003 dengue vaccine, 5 of 13,380 TAK-003 recipients and 13 of 6,687 placebo recipients experienced two episodes of symptomatic dengue between the first dose and the end of the study, ∼57 months later (patients received the second dose 3 months after the first dose). Two of these participants experienced repeat infection with the same serotype (i.e.

Three-year Efficacy and Safety of Takeda's Dengue Vaccine Candidate (TAK-003).

Background: Takeda's live attenuated tetravalent dengue vaccine candidate (TAK-003) is under evaluation in a long-term clinical trial across 8 dengue-endemic countries. Previously, we have reported its efficacy and safety in both seronegative and seropositive participants and that its performance varies by serotype, with some decline in efficacy from first to second year postvaccination. This exploratory analysis provides an update with cumulative and third-year data.

Genetic Variation in the Domain II, 3' Untranslated Region of Human and Mosquito Derived Dengue Virus Strains in Sri Lanka.

Genetic variations in dengue virus (DENV) play a distinct role in epidemic emergence. The DENV 3' UTR has become a recent interest in research. The objective of the study was to examine the genetic variation in the domain II, 3' UTR region of human and mosquito-derived DENV.

Efficacy of a Dengue Vaccine Candidate (TAK-003) in Healthy Children and Adolescents 2 Years after Vaccination.

Background: Takeda's dengue vaccine is under evaluation in an ongoing phase 3 efficacy study; we present a 2-year update.

Methods: Children (20 099, 4-16 years old) were randomized to receive 2 doses of TAK-003 or placebo 3 months apart and are under surveillance to detect dengue by serotype-specific RT-PCR.

Results: Cumulative efficacy against dengue approximately 27 months since first dose was 72.

Efficacy of a Tetravalent Dengue Vaccine in Healthy Children and Adolescents.

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.

Predictive value of persistent NS1 antigen positivity beyond 3rd day for dengue haemorrhagic fever in Sri Lankan children.

Objective: Dengue haemorrhagic fever (DHF) is a major public health concern responsible for significant morbidity in both adult and paediatric populations in Sri Lanka. This study examined if persistent non structural protein 1 (NS1) antigen positivity beyond day 3 was predictive of the occurrence of dengue haemorrhagic fever. The patients were followed up during their in-hospital stay and the severity of the illness was classified according to the WHO classification.

NS 1 lasts longer than the dengue virus nucleic acid in the clinically suspected patients with dengue fever and dengue haemorrhagic fever.

The objectives of the study were to compare the DENV NS1 and nucleic acid positivity in dengue fever (DF) and dengue haemorrhagic fever (DHF) patients and to evaluate the usefulness of these parameters in severe dengue. Blood samples were collected from 91 patients with DF or DHF (fever days 3-9) from Gampaha and Negombo General Hospitals, Sri Lanka and tested for DENV NS1 antigen and nucleic acid. On fever day 3, 67% of the DF and 33% of the DHF patients had DENV nucleic acid whereas 50% of the DF and 67% of the DHF patients had NS1.

Effect of Climatic Factors and Population Density on the Distribution of Dengue in Sri Lanka: A GIS Based Evaluation for Prediction of Outbreaks.

Dengue is one of the major hurdles to the public health in Sri Lanka, causing high morbidity and mortality. The present study focuses on the use of geographical information systems (GIS) to map and evaluate the spatial and temporal distribution of dengue in Sri Lanka from 2009 to 2014 and to elucidate the association of climatic factors with dengue incidence. Epidemiological, population and meteorological data were collected from the Epidemiology Unit, Department of Census and Statistics and the Department of Meteorology of Sri Lanka.