Publications by authors named "Reynales H"
Cost of dengue in Colombia: A systematic review.
PLoS Negl Trop Dis
December 2024
Background: Dengue is hyperendemic in Colombia. It imposes a substantial economic burden on patients, caregivers, society, and the national health system. We intend to identify and synthesize the evidence regarding the economic burden of dengue in Colombia.
View Article and Find Full Text PDFDengue is the most important viral vector-borne disease in the tropics, with Colombia being one of the most affected countries. In this context, it is essential to identify and synthesize the existing evidence on the epidemiology of dengue in Colombia. A systematic review (PROSPERO CRD42021257985) was conducted by searching for epidemiological data in populations with suspected or confirmed dengue in Colombia from 2012 to 2020.
View Article and Find Full Text PDFAims: Early detection of type 2 diabetes mellitus is key to reducing micro and macrovascular complications associated with this disease. However, a lab-based process for diagnosis entails the risk of loss-to-follow-up. The objective of this study was to demonstrate if performing a point-of-care test of HbA1c immediately after a screening questionnaire will increase the proportion of individuals showing up for a lab-based confirmatory test as Point-of-care (POC) provides immediate availability, which is expected to reduce loss-to-follow-up.
View Article and Find Full Text PDFBackground: 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.
Article Synopsis
- The study investigated how previous vaccinations for Yellow Fever (YF) and Japanese Encephalitis (JE) affect the effectiveness of the dengue vaccine candidate, TAK-003, in children aged 4-16 years.
- Out of 20,071 participants, different levels of vaccine efficacy were observed: 55.7% in those previously vaccinated for YF, 77.8% for JE, and 53.5% for those with no prior vaccinations, but these results were influenced by the regional distribution of dengue virus serotypes.
- Overall, the findings indicate that prior YF or JE vaccinations do not significantly impact the efficacy of TAK-003, which was well-tolerated across various epidemiological settings.
Article Synopsis
- About half of the global population lives in areas where dengue fever is common, leading researchers to test the tetravalent dengue vaccine TAK-003 for its long-term effectiveness in children and adolescents aged 4-16.
- The study is a double-blind, placebo-controlled trial conducted across eight dengue-endemic countries, enrolling over 20,000 participants, and focusing on the vaccine's ability to prevent symptomatic dengue disease.
- Results will be evaluated over approximately 4.5 years, monitoring both efficacy and the incidence of serious adverse events, with ongoing oversight to ensure participant safety.
Background: The literature on first generation COVID-19 vaccines show they were less effective against new SARS-CoV-2 variants of concern including Omicron (BA.1, BA.2, BA.
View Article and Find Full Text PDFBackground: COVID-19 vaccines with alternative strain compositions are needed to provide broad protection against newly emergent SARS-CoV-2 variants of concern. This study aimed to describe the clinical efficacy and safety of a bivalent SARS-CoV-2 recombinant protein vaccine as a two-injection primary series during a period of circulation of the omicron (B.1.
View Article and Find Full Text PDFIn 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.
View Article and Find Full Text PDFBackground: COVID-19 vaccines with alternative strain compositions are needed to provide broad protection against newly emergent SARS-CoV-2 variants of concern.
Methods: We conducted a global Phase 3, multi-stage efficacy study (NCT04904549) among adults aged ≥18 years. Participants were randomized 1:1 to receive two intramuscular injections 21 days apart of a bivalent SARS-CoV-2 recombinant protein vaccine with AS03-adjuvant (5 μg of ancestral (D614) and 5 μg of B.
Background: The allergic phenotype is responsible for more than 50% of severe asthma cases. In a stepwise approach, add-on treatments such as anti-IgE are used for severe allergic asthma (SAA). This study was aimed to describe the real-world effectiveness of omalizumab in adult and pediatric patients with SAA in Colombia.
View Article and Find Full Text PDFArticle Synopsis
- The study evaluated the safety and efficacy of the SCB-2019 COVID-19 vaccine in a large, double-blind, placebo-controlled trial involving over 30,000 adults across five countries.* -
- Participants were randomly assigned to receive either the vaccine or a placebo, and the primary focus was on measuring vaccine effectiveness against COVID-19 and monitoring adverse effects.* -
- Results showed that the vaccine had an overall efficacy of 67.2% against any severity of COVID-19, and 83.7% efficacy against moderate-to-severe cases, indicating its potential effectiveness in preventing the disease.*
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.
View Article and Find Full Text PDFBackground: CYD-TDV, a live, attenuated, tetravalent dengue vaccine, has been approved for the prevention of symptomatic dengue in previously dengue exposed individuals. This post hoc analysis assessed hospitalized and severe virologically confirmed dengue (VCD) over the complete 6-year follow-up of 3 CYD-TDV efficacy studies (CYD14, CYD15, and CYD23/CYD57).
Methods: The main outcomes were hazard ratios (HRs) for hospitalized or severe VCD by baseline dengue serostatus, focusing on those who were seropositive, and by age at immunization (<9 years/≥9 years).
Background: The absolute degree of protection from influenza vaccines in older adults has not been studied since 2001. This study aimed to show the clinical efficacy of an MF59-adjuvanted quadrivalent influenza vaccine (aQIV) in adults 65 years or older compared with adults not vaccinated to prevent influenza.
Methods: We did a randomised, stratified, observer-blind, controlled, multicentre, phase 3 study at 89 sites in 12 countries in 2016-17 northern hemisphere and 2017 southern hemisphere influenza seasons.
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.
A phase III dengue vaccine trial including 9- to 16-year-olds in Latin America (NCT01374516) was ongoing at the time of a Zika outbreak. We explored interactions between dengue and Zika, in the context of dengue vaccination. Symptomatic virologically confirmed Zika (VCZ) was evaluated using acute-phase sera from febrile participants (January 2013-March 2018).
View Article and Find Full Text PDFBackground: 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.
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.
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.
Background: A candidate tetravalent dengue vaccine is being assessed in three clinical trials involving more than 35,000 children between the ages of 2 and 16 years in Asian-Pacific and Latin American countries. We report the results of long-term follow-up interim analyses and integrated efficacy analyses.
Methods: We are assessing the incidence of hospitalization for virologically confirmed dengue as a surrogate safety end point during follow-up in years 3 to 6 of two phase 3 trials, CYD14 and CYD15, and a phase 2b trial, CYD23/57.
To prepare for a Phase III dengue vaccine efficacy trial, 20 investigational sites were selected for this observational study to identify dengue infections in a closed cohort (N = 3,000 children 9-16 years of age). Of 255 acute febrile episodes experienced by 235 children, 50 (21.3%) were considered serologically probable dengue, and 18 (7.
View Article and Find Full Text PDFBackground: In light of the increasing rate of dengue infections throughout the world despite vector-control measures, several dengue vaccine candidates are in development.
Methods: In a phase 3 efficacy trial of a tetravalent dengue vaccine in five Latin American countries where dengue is endemic, we randomly assigned healthy children between the ages of 9 and 16 years in a 2:1 ratio to receive three injections of recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV) or placebo at months 0, 6, and 12 under blinded conditions. The children were then followed for 25 months.
Article Synopsis
- The study aimed to compare the immunogenicity, safety, and effectiveness of an MF59-adjuvanted trivalent influenza vaccine (aTIV) with a non-adjuvanted vaccine (TIV) in individuals aged 65 and older.
- Over 7,000 participants received either aTIV or TIV, and results showed that aTIV produced significantly higher antibody responses than TIV after 22 days, although it did not meet all criteria for superiority.
- While aTIV caused slightly more mild to moderate side effects, it demonstrated a potential advantage in boosting immune responses in elderly patients, particularly against A/H3N2 influenza strains.
Background: The present study was a prospective observational study to evaluate the safety profile of Celtura(®), a monovalent, cell culture-derived, inactivated subunit influenza vaccine prepared from A/California/07/2009(H1N1) with the adjuvant MF59(®). Subjects were enrolled prospectively during the H1N1 2009 influenza pandemic at medical centres in Colombia, Chile, Switzerland, and Germany during the period December 2009 to June 2010.
Methods: Subjects ages 18 and older were followed for the occurrence of adverse events (AEs) for six months after vaccination.