Investigating Vector-Borne Determinants of Aedes Transmitted Arboviral Infections in Cambodia: An Observational Longitudinal Cohort Study in Children
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|ClinicalTrials.gov Identifier: NCT03534245|
Recruitment Status : Active, not recruiting
First Posted : May 23, 2018
Last Update Posted : July 17, 2019
Some mosquitos carry viruses that can cause disease. Some examples are dengue and Zika. The mosquitos spread disease by biting people and infecting them with the virus. Children, elderly people, and people who are already sick are especially likely to get infected. Researchers want to learn more to help make new medicines to treat these viral infections.
To learn more about how mosquitos infect people, and why young children are more likely to get sick than other people.
Healthy children 2-9 years old who live near the study site. This is Kampong Speu District Referral Hospital in Chbar Mon, Cambodia.
At visit 1, participants will have a physical exam. A small amount of blood will be taken from their arm or finger. Parents will answer questions about the participant s general health and medical history.
Participants will come back to the study site every wet season and every dry season for the next 3 years. The visits will be the same as visit 1 and take about 1 hour.
If at any time during the study the participant gets a fever and has other symptoms that could be caused by these viral diseases, they should be brought to the study site. These symptoms might include headache, pain behind the eyes, muscle pain, or joint pain. They can also include a rash that lasts longer than 12 hours.
Participation ends after the final study visit in late 2021.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||775 participants|
|Official Title:||Investigating Vector-Borne Determinants of Aedes-Transmitted Arboviral Infections in Cambodia: an Observational Longitudinal Cohort Study in Children|
|Actual Study Start Date :||May 16, 2018|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||September 30, 2021|
Healthy children aged 2 - 9 years
- Prevalence of symptomatic and inapparent dengue infection (serotypes 1-4) as detected semiannually via ELISA assay (binary outcome present/absent) over a three-year period in Kampong Speu in children aged 2-9 years old [ Time Frame: Semi-Annual visits and sick/convalescent visits throughout study enrollment ]Detailed knowledge of dengue seroprevalence and transmission season variability will help establish an epidemiological foundation to prepare for larger future studies such as disease incidence studies or vector interventional trials.
- Prevalence of Aedes aegypti salivary gland homogenate reactivity as detected by ELISA assay (binary outcome present/absent) during wet and dry seasons over a three-year period in Kampong Speu in children aged 2-9 years old [ Time Frame: Semi-annual visits and sick/convalescent visits throughout study enrollment ]Characterizing the Ae. aegypti salivary protein reactivity profile in Cambodians is the first step prior to assessing how Ae. aegypti saliva exposure modulates disease in humans.
- Western blot analysis of sera from participants with strongest ELISA positivity to Ae. aegypti whole salivary gland homogenate compared to Anopheles and Culex to assess cross-reactive immunogenicity to mosquito saliva versus specific Aedes marke... [ Time Frame: Semi-annual visits and sick/convalescent visits throughout study enrollment ]
- Positive RT-PCR result for diagnosis of dengue, chikungunya, and Zika viruses (or IgM capture ELISAs for dengue as needed) [ Time Frame: Semi-annual visits and sick/convalescent visits throughout study enrollment ]
- Geographic information system with all data components (mosquito catch sites, houses, schools) referenced by latitude and longitude in addition to a series of map layers (point maps, smoothed maps) to evaluate relationships between IgG intensity... [ Time Frame: Semi-annual visits and sick/convalescent visits throughout study enrollment ]
- Seroconversion to Ae. aegypti salivary homogenate in relationship to season (wet versus dry) and collected time-dependent variables defined as mean and maximum rainfall, te,perature and humidity [ Time Frame: Semi-annual visits and sick/convalescent visits throughout study enrollment ]
- Capture a minimum of 25 female Aedes aegypti mosquitoes for transcriptional comparison to LMVR-reared Aedes aegypti mosquitoes [ Time Frame: Duration of study enrollment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03534245
|Kampong Speu Referral Hospital|
|Chbar Mon, Kampong Speu, Cambodia|
|Principal Investigator:||Jessica E Manning, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|