View clinical trials related to Dengue.
Filter by: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.
Background Dengue is a mosquito-borne viral disease caused by four distinct but closely related dengue virus (DENV). The incidence of dengue has grown dramatically worldwide in recent decades, with cases reported to WHO increased from 505,430 cases in 2000 to 5.2 million in 2019. The total number of dengue cases in Malaysia has increased from merely 6,543 cases in the year 1995 to 130,101 cases in the year 2019. Knowledge, attitude and practice remain the most effective driving tool against dengue prevention and control and it becomes very necessary to plan an integrated module for the primary prevention of dengue infection especially among school children. Aims The present study intends to develop, implement and evaluate the effectiveness of theory-based integrated dengue education module in improving the knowledge, attitude, practice, environmental cleanliness index, and dengue index among school children in Selangor and Kuala Lumpur. Methods This study is a single-blinded, cluster randomized controlled trial study, expected to be conducted from 1st June 2023 to 31st May 2025 among 20 primary dan 20 secondary schools in Selangor and Kuala Lumpur. The respondents will be allocated into intervention and control groups randomly based on selected clusters to avoid contamination. The intervention group will receive IDEM, while the control group will receive standard education. The outcome will be measured using validated, self-administered questionnaires at four time points: baseline (T0), Immediately (T1), one month (T2), and three months (T3) post-intervention to measure the effectiveness of the intervention module. The data will be analysed using IBM Statistical Package for Social Science (SPSS) version 28 involving descriptive and inferential statistics. The Generalized Linear Mixed Model (GLMM) will be used to test the main effect and interaction between and within the intervention and control groups over time at T0, T1, T2 and T3. This study will use a significance level with a p-value of 0.05 and a confidence interval of 95% for hypothesis testing
It is not known whether there is a different clinical profile of dengue in patients with immune system dysfunction. Preliminary data and previous literature suggest that autoimmune diseases, and in particular their treatment, may favour the evolution to severe forms of dengue. Our research hypothesis is that the clinico-biological presentation of dengue might be different in case of autoimmune disease, either on the side of overactivation (autoimmune and auto inflammatory diseases without treatment) or immunodepression (autoimmune and auto inflammatory diseases under immunosuppressive treatment).
Dengue is an endemic infectious disease in Malaysia. Delays in seeking treatment and improper self-care contribute to dengue complications and mortality. A mobile app (Dengue Aid) was developed to educate and empower patients to perform evidence-based self-care when having dengue fever. DengueAid is hypothesised to improve people's knowledge and health-seeking intention on dengue. This will be evaluated via an online randomised controlled trial. Adults aged 18 and above who have Facebook, an android smartphone and understand either English or Malay language will be recruited through Facebook advertisements. Eligible participants would be randomized to either using the DengueAid app (intervention) or MyHEALTH website (control). An online randomizer tool will be used to randomize participants into the intervention or control group. Participants in both arms would complete a post-intervention online questionnaire (knowledge and health-seeking intention) three days after recruitment.
Dengue viral infection and dengue hemorrhagic fever (DHF) are important emerging health problems worldwide. Several candidate dengue vaccines are currently in different stages of development but CYD is the only licensed vaccine currently available. Although this vaccine can induce neutralizing antibodies against all four DENV serotypes, the vaccine showed enhanced hospitalization in recipients who were dengue-naïve before vaccination. The long-term safety assessment of the vaccine in endemic regions demonstrated that the risk of hospitalization in year 3 of vaccination was higher in the vaccine group especially among recipients under 9 years of age with a relative risk of 1.58 [95% CI, 0.83 to 3.02]. Surrogate animal models are not good models to see whether the vaccine or therapeutic is able to be tested in clinical trials since animals do not develop symptoms of infection as in humans. The ADE phenomenon and the lack of known correlates of protection in animal models are still the major problems and challenges in the development of an effective dengue vaccine and make it difficult to identify candidate vaccines. The efficacy and safety situation of CYD also highlights the requirement of verification of candidate vaccines before performing clinical trials with a large number of participants. The controlled human infection model, therefore, has been proposed to pre-evaluate candidate vaccines before moving into larger clinical trials. It has been previously used for several infectious diseases i.e., malaria, norovirus, influenza, cholera, Campylobacter, and Shigella, to accelerate vaccine or therapeutic development. For dengue, two controlled dengue human infection models (DHIM) have been established for vaccine testing and evaluation of therapeutics in a dengue naïve population in the USA. Although it has been proved useful for studies of dengue in naïve individuals, it is necessary to set up DHIM in endemic regions like Thailand as more than 90% of the population has been previously exposed to the virus and, importantly, host immune status prior to the introduction of viruses can influence clinical outcomes and vaccine efficacy. It will also be very challenging in terms of safety concerns since having pre-existing immune responses to natural DENV infection is a risk factor for severe dengue. The establishment of DHIM will not only allow a small-scale demonstration for safety and efficacy of vaccines or therapeutics which can appropriately guide the design of phase III to be more cost-effective but it will also allow the investigation of immune correlates of protection and determination of factors correlated with disease protection and pathogenesis as clinical endpoints can be closely followed up in all participants. Safety, Virological and Immunological Assessment of the Controlled Dengue Human Infection Model in Thailand (DHIT) is proposed to challenge the live attenuated dengue virus serotype 2, rDEN2Δ30-7169, in 5 flavivirus naïve participants recruited from Bangkok, Thailand, and aims to assess the safety, viremia, NS1 antigenemia profile, and immunogenicity of the challenge virus in the volunteers. In addition, this DHIT project will vaccinated all 5 participants with Dengvaxia® after inoculation with the challenge virus to reduce the risk of severe disease of dengue in the future. Blood collection will be obtained after each vaccination to assess virological and immunological profiles. Active and passive surveillance will be set up to monitor for dengue infection after vaccination. The overall study period from administration of live attenuated virus until last follow-up visit is 38 months.
Among all arboviruses, Dengue (DEN) is the vector borne disease with the highest burden worldwide. Around 390 million infections per year are estimated, of which around 96 million are clinically apparent. Since its re-emergence in 1998 in Argentina, DEN has shown an epidemic behavior affecting mainly the northern and central regions in which the circulation of serotypes has been heterogeneous. The last significant outbreak was registered between the end of 2019 and the beginning of 2020.. Vaccine development for DEN prevention has been a long and challenging journey. The only vaccine that has reached registration to date is a recombinant attenuated tetravalent vaccine (Dengvaxia, Sanofi Pasteur) showing an efficacy against virological confirmed DEN infection of 36.6% (4.2-61.4) in seronegative subjects at baseline and 77.9% (65.1-86.0) in seropositive. However, this vaccine has not been pre qualified by the World Health Organization. New dengue vaccines are in advanced stages of development worldwide. At least three vaccines are in advanced stages of development including one produced by Takeda, the Butantan Institute and the Merck, Sharp & Dohme development. The implementation of a vaccination strategy in Argentina could be a health-relevant approach. However, the best way to implement this requires prior information describing and investigating numerous aspects of vaccination including acceptability. A systematic review of two acceptability surveys showed an acceptability of 77% to 86% but in countries with endemic DEN at time of the surveys. It is possible that in Argentina, the introduction to the regular calendar, for use in specific regions with a high and periodic burden of disease, of highly effective and safe DEN vaccines will be considered. However, to our knowledge, we do not have available evidence of the potential acceptability of these vaccines. The main objectives of this research will be: To evaluate the acceptability of a DEN vaccine in potential target populations in regions of high burden of disease in Argentina. Describe main determinants of and barriers to DEN vaccine acceptability in regions of high burden of disease in Argentina. Identify information and intervention needs to design and implement communication strategies that have a positive impact on the acceptability of a DEN vaccine.
Dengue Hemorrhagic Fever is a mosquito-borne viral disease endemic in the Philippines which caused multiple epidemics. Most points to the activation of the complement system secondary to humoral respond leading to cytokine release causing systemic inflammation. Melatonin, is a hormone which has an a) anti-viral, b) immunomodulator, c) antioxidant, d) modulatory effect on hematopoiesis and e) anti-inflammatory action. This is a randomized control trial to determine the effectiveness of adjunctive melatonin therapy among patients diagnosed with Dengue fever with Warning Signs. This would include children aged 5 to 18 years old with no signs of hemmorhagic shock. They would be randomly assigned into 2 groups. Baseline Complete blood count with platelet (CBCPC) will be collected. Daily CBCPC will be collected and would be statistically analyze after the study.
Background: Dengue continues to be a high priority disease for public health in tropical and subtropical countries, where vector control measures have not had the expected impact on transmission. The development of new vaccines opens the possibility of having an additional measure capable of preventing the development of the disease and avoiding its complications. Currently, in two of the Dengue virus (DENV) vaccines a differential behaviour of the immune response has been observed between seropositive and seronegative individuals, which makes the generation of evidence from prevalence studies in places of high and low endemicity more relevant. Objective: To determine the predominant type of humoral immune response in high areas and to estimate the serotype-specific prevalence for DENV in people groups aged 5 to 35 years living in Mexican cities with low and high dengue endemicity. Methodology: Descriptive cross-sectional study with subgroup analysis (by endemic and non-endemic areas, by age groups and by sex). Expected results: In areas of low dengue endemicity the humoral immune response against dengue is predominantly monotypic (against one serotype) while in areas of high dengue endemicity it is predominantly multitype (against two or more serotypes).
The investigators hypothesize that sex, age, area of exposure and purpose of travel are associated with different travel-related infections. The investigators also hypothesize that certain infections will have long-term sequelae. Health-data will be collected from travellers from Switzerland and Europe. The project starts with a pilot study for 50 travellers, followed by the recruiting of 10,000 travellers. The data collection will be via a mobile App (ITIT). The ITIT App will collect active data from travellers. The participants will download the App after signing an electronic consent form and completing a baseline questionnaire. Then the travellers will answer a short daily questionnaire about illness symptoms during travel. The ITIT App will also collect passive data (GPS localisation, environmental and weather data). The project will provide real-time data on travel-related infections and profile travel illness by age, sex and purpose of travel and also identify outbreaks.
A mobile suitcase laboratory for EBOV point-of-care (POC) detection at Ebola treatment centers was successfully implemented in Guinea during the large Ebola virus disease (EVD) outbreak in West-Africa 2014-2015. It was shown that isothermal amplification (Recombinase Polymerase Amplification (RPA)) could be efficiently used to test suspect EVD cases and local teams were trained in and successfully deployed with this fast method. In the frame of this project we want to train teams in DRC and expand RPA testing capacity to the differentials recommended by the WHO. Existing RPA assays for all parameters will be included into a multistrip for simultaneous use. This will be integrated with a simple biosafe extraction method. Implementing this approach and testing in the ongoing EVD outbreak will provide teams in DRC with response capacity for future EVD outbreaks.