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NCT06579755
Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. Researchers have seen that dengue fever now also happens more often in elderly persons. The main aim of this study is to learn more about the side effects of TDV in adult (45 - 60 years) and elderly (60 - 79 years) persons and about TDV's ability to create an immune response in adult and elderly persons. Another aim is to learn about the side effects of TDV in adult and elderly persons in endemic countries who have one or more additional medical conditions (called comorbidities) such as diabetes mellitus, hypertension or a chronic kidney condition. In this study, participants will receive 2 vaccinations with TDV (the second 3 months after the first). During the study, participants will visit their study clinic 5 times.
NCT06599970
In contrast to the trend expected based on existing prediction models, dengue incidence was historically low during the pandemic mobility restrictions of 2020-2021 in most dengue endemic countries. This highlights that current transmission models do not correctly take human mobility into account. Within a pilot-study in Cienfuegos, South-Central Cuba, we will characterise the epidemiological spread and distribution of dengue outbreaks (2012-2025) in districts repeatedly involved in previous dengue outbreaks as initiating, case-concentrating or transmission sustaining areas. This will be linked with fine-grained mobility data and socio-spatial characterizations of commuting flows and population hubs where people are concentrated during day-time (time when transmission happens). This information, together with entomological and environmental risk-data, will be used to i) improve the accuracy of mathematical dengue models, ii) better understand the transmission process and iii) inform and improve the design of disease control strategies. The project will contribute to much-needed evidence-based guidance for public health actors on improved prevention strategies of epidemics dispersion and where and when to implement control measures.
NCT07520279
This is a multi-site, observational, cross-sectional clinical study that includes geographically diverse sites within and outside the United States.
NCT06595745
Mosquito-borne diseases cause suffering for hundreds of millions of people and claim more than 700,000 lives yearly. Diseases such as dengue, Zika, and chikungunya cause symptoms similar to malaria and are endemic in many parts of the world, yet there are no treatments for them nor vaccines for Zika and chikungunya. Mosquito control, particularly of the Aedes aegypti species, is seen as a potentially effective solution to slow or stop the spread of these diseases but has not yet demonstrated significant, sustainable impacts on disease transmission. The investigators will aim to significantly control or eliminate local foci (hot-spots) of dengue, chikungunya and Zika transmission and significantly reduce disease transmission by implementing a combined incompatible and sterile insect technique (IIT-SIT) program based on the release of male Aedes aegypti carrying Wolbachia (wAlbB strain) that have been previously irradiated with X-rays (to minimize the chance of fertile female releases). The investigators will implement a two-arm cluster randomized controlled trial to evaluate the epidemiological and entomological impact of population suppression via IIT-SIT on Aedes-borne diseases in the city of Merida, Mexico. Primary endpoint of the trial is the incidence of laboratory Aedes-borne viruses detected by the passive surveillance system of Mexico. Secondary endpoints will allow estimating the level of suppression of Ae. aegypti populations. This trial design will allow establishing a link between epidemiologic, entomo-virological and entomological indicators to determine the effectiveness of IIT-SIT in real world conditions. The approach is novel because it effectively eliminate vectors, such as urban, outdoor, daytime biting mosquitoes, which are not susceptible to standard vector control approaches, by targeting cryptic and inaccessible mosquito habitats. In addition, the intervention has the below advantages comparing to existing alternatives: (i) highly competitive males are used for release as Wolbachia-infected males have the mating competitiveness equal to wild-type males; (ii) release can continue until population elimination is reached as a low dose of radiation is used to sterilize females for preventing risk of population replacement; (iii) any residual females contaminated in released male pools is resistant to pathogens; (iv) public acceptance of release of Wolbachia-infected males can be easily achieved, because Wolbachia are bacteria naturally presenting in \~50 percent of insect species, and male mosquitoes neither bite nor transmit diseases and can be self-limiting post release; (v) it will not impact non-target species. Successful findings from this study will pave the way for future expansions of the combined IIT-SIT to the entire city and nationwide using a rolling-carpet strategy, which has been successfully demonstrated for area-wide control of screwworm and medfly in Latin America.
NCT07432061
Dengue is a rapidly emerging infectious disease in South and Southeast Asia. Definitive diagnosis requires laboratory testing (PCR or antigen testing) which are often unavailable in settings with highest incidence. Correctly identifying patients who have dengue, and the small number of patients with dengue who will progress to severe disease is important to ensure prompt institution of appropriate treatments. Existing models use a combination of clinical and laboratory features. A model developed and tested on data from 397 patients admitted to the Hospital for Tropical Diseases in Bangkok in 2013 - 2014 used Bayesian modelling of variables (liver and full blood count) and clinical symptoms (including fever, petechiae, bleeding) to distinguish dengue from other febrile illness. The resultant model performed had an AUC of 0.75 which improved to 0.8 when NS1 was included. The Sequential Organ Failure (SOFA) scores, or modified versions use vital sign and blood test (liver, renal and haematology) data and are good indicators of those likely to die. However, they function less well in moderately severe diseases (e.g. predicting need for ICU admission). These approaches are promising, but are limited by limited generalizability, use of multiple blood tests and clinical symptoms. A low-cost easy tool able to rapidly diagnose dengue and predict disease severity would be of great value in the region. With modern machine learning methods, this is now feasible and previously identified barriers such as the requirement for large amounts of training data can now be overcome. For example, models can be created from large datasets, but then optimized for smaller different datasets (data either from other locations/conditions, or with less input data). We've previously shown that data-driven machine learning algorithms could generalize across multiple United Kingdom (UK) National Health Service (NHS) Trusts (for predicting COVID-19). Whilst initially trained on data from over 77,000 patients, we created a model requiring only vital sign data and bedside blood count able to predict COVID-19 diagnosis in patients presenting at UK hospitals. We have demonstrated ability to adapt this model for a lower middle-income country (LMIC) setting using data from two Vietnamese hospitals. The adapted models achieved AUROCs around 0.75 and AUPRCs around 0.89 (similar to UK sites where much larger amounts of data were available). Performing "transfer learning," whereby a small subset of UK data was used to support model development in Vietnam, improved performances between 5-10%. We also found that using statistical methods for addressing missing values can further improve predictive performance by 2-5%. This machine learning model can also function as a 'baseline model' and be adapted for a new task i.e. dengue.
NCT04486638
The primary objective of this study is to assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women and their offspring(s) vaccinated with Dengvaxia during their pregnancy
NCT06741683
Dengue fever is caused by an infection with the dengue virus. Vaccination with TDV can help prevent dengue fever. The main purpose of this study is to learn about TDV's ability to create an immune response in adults, adolescents, and children administered. In this study, participants will receive 2 vaccinations with TDV (the second 3 months after the first). During the study, participants will visit their study clinic 5 times. Participants will be in this study for approximately 270 days (9 months).
NCT04514107
This is a cluster randomized controlled trial (CRCT) to evaluate the efficacy of Wolbachia-infected A. aegypti mosquito releases in reducing the burden of ARBV infection in Brazil over four years. The intervention will be the release of Wolbachia-infected A. aegypti mosquitoes. Standard control measures routinely established by the Belo Horizonte City Hall as recommended by the PNCD, will continue to be performed by the Belo Horizonte Health Department (Zoonoses Management) in all clusters, that is, the standard control measures will be carried out throughout the city of Belo Horizonte, independent of this clinical study. Wolbachia-infected A. aegypti will be deployed by releasing adult mosquitoes in pre-determined, thoroughly spaced release points in easily accessible roads described in a release map. A release map will be generated for each cluster and the numbers of release points will be determined by population density, surface area and mosquito abundance. Wolbachia-infected A. aegypti mosquitoes will be deployed across intervention clusters in two stages: 1) a 4 month establishment stage in which most of the releases will occur and 2) followed by an 8 month consolidation stage in which the abundance of Wolbachia-infected mosquitoes will be measured and remedial deployments will be completed, if needed, with the aim of achieving a high prevalence of Wolbachia amongst A. aegypti mosquitoes in intervention clusters within 12 months from the start of the release. The goal is to reach a Wolbachia prevalence of 60% or higher. Monitoring of Wolbachia prevalence in the cluster will continue throughout the study period, but no further mosquito deployments will occur after the consolidation stage is complete. The primary objective is to evaluate whether release of Wolbachia-infected Aedes aegypti mosquitoes plus standard Aedes vector control measures reduces the sero-incidence of ARBV infection compared to standard Aedes vector control measures alone.
NCT07205848
This study evaluates the awareness of dengue fever and preventive measures among Sudanese people during the war. It assesses knowledge, awareness, implementation of prevention, access to healthcare, community involvement, and the link between knowledge and practice. The findings aim to enhance disease control strategies in conflict settings.
NCT07206784
This study is a collaboration between the School of Public Health at Fudan University and the Xishuangbanna Center for Disease Control and Prevention in Yunnan Province, China. It aims to evaluate the public health impact of dengue vaccination strategies using dynamic transmission models. By simulating different vaccination scenarios, the study will assess the potential effectiveness and public health benefits of dengue vaccine introduction, providing scientific evidence to support local dengue prevention and control efforts.
NCT07203183
The objective of this study is to collect well-characterized serum and plasma specimens from confirmed dengue positive and dengue negative subjects to support dengue diagnostic products development.
NCT04343521
The objective of this trial is evaluate the efficacy of Targeted Indoor Residual Spraying (TIRS) in preventing symptomatic disease caused by Aedes-borne diseases (ABDs) in children 2 to 15 years of age in the city of Merida, Yucatan State, Mexico.
NCT07007585
This 3-year prospective observational study aims to identify clinical and laboratory risk factors associated with hospitalization in patients with confirmed dengue virus infection. It also seeks to analyze real-world transfusion practices and their outcomes. The study will be conducted in a second-level hospital in northern Mexico and will follow patients from emergency department entry to clinical resolution or hospital discharge.
NCT07112846
Exanthematous fevers are a global public health problem. The spread of arboviruses due to various factors, including climate change, has resulted in major epidemics such as the one that occurred in Brazil in 2024, representing an extremely concerning scenario from both epidemiological and healthcare perspectives. In addition to this, the reemergence of childhood exanthematous diseases in several countries, including Brazil, is alarming and occurs due to declining vaccination coverage and increased migratory movements. These diseases present overlapping clinical symptoms, and their differential diagnosis is often challenging, which, in a context of dengue and Chikungunya epidemics like the current one, may lead to underreporting of diseases such as measles and rubella. This project aims to build a prospective registry of the occurrence of dengue, Chikungunya, measles, and rubella in various healthcare centers in Brazil, in order to better understand the epidemiological scenario, identify clinical variables associated with different diagnoses, and describe healthcare bottlenecks that may hinder proper reporting and identification of these diseases.
NCT06665035
Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. The purpose of this study is to collect information of vaccination with TDV when given to children younger than 2 years. The main aims of this study are to learn how safe the vaccine is and how well it works to activate a young child's immune system (this is called immunogenicity). Children between the age of 6 and 21 months will receive two vaccinations with either TDV or placebo 3 months apart. Blood samples will be taken before and after the vaccination as well as throughout the study. These are necessary to check how well the vaccine works to activate the immune system. During the study, participants will visit their study clinic 8 times for vaccinations, blood draws and health checks.
NCT07040202
The goal of this research study is to help the investigators better understand serious dengue disease. The investigators will collect clinical information and up to four blood samples from participants with dengue, sepsis, or healthy people. The investigators will perform multiple analyses on the blood samples and compare results between dengue patients and those with sepsis and healthy people.
NCT06388785
The main aim of this study is to collect the number and type of medical problems (adverse events) after vaccination with QDENGA in Malaysia and to learn more about such medical problems after vaccination. Another aim of this study is to collect the number of persons vaccinated with QDENGA who need to stay in the hospital because of severe dengue fever. No vaccination will be given as part of this study. The study will only collect data of persons already vaccinated with QDENGA who agree to participate.
NCT03999996
The purpose of this study is to describe antibody persistence for each of the 4 dengue serotypes for up to 63 months after the first vaccination in the primary vaccination series for participants from parent trial DEN-315 (NCT03341637) (Mexico) and for up to 36 months after the first vaccination in the primary vaccination series for participants from parent trial DEN-304 (NCT03423173) (United States \[US\]) and to describe the impact of a tetravalent dengue vaccine (TDV) booster dose vs placebo on antibody response for each of the 4 dengue serotypes at 1 month and 6 months post administration of the TDV booster or placebo.
NCT07002021
The goal of this cluster randomized controlled trial is to evaluate the effect of health education interventions on the score of the knowledge, attitudes, and practices (KAP) of dengue in in primary and middle school students in the city of Guangzhou and Foshan in China. Individuals aged 6 to 15 years who are in grades 1-9 in primary schools in Guangzhou and Foshan will be enrolled. 20 primary schools will be randomly selected, with half designated as intervention group schools and the remaining half as control group schools. The intervention group will receive a health education intervention focused on dengue prevention every semester for 6 months, while the control group will continue with their routine school health education for 6 months. Researchers will compare the differences in the score of the KAP of dengue between the intervention and control groups after 6 months to see if health education can improve knowledge, attitudes and practices of dengue among primary and middle school students.
NCT06747130
The goal of this clinical trial is to learn if drug montelukast works to treat dengue in adults. It will also learn about the safety of drug montelukast . The main questions it aims to answer are: Does drug montelukast lower the incidence of liver enzyme elevations in participants ? What medical problems do participants have when taking drug montelukast ?