Effect of Baseline Dengue Serostatus Among Tetravalent Dengue Vaccine CYDTDV (Dengvaxia®) Recipients on Subsequent Virologically Confirmed Dengue in the Philippines
| Registry | NCT03465254 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 2996 (Actual) |
| Sponsor | University of the Philippines (Other); collaborators: Department of Health, Philippines, World Health Organization, Research Institute for Tropical Medicine, Philippines, University of North Carolina, La Jolla Institute for Allergy & Immunology, International Vaccine Institute |
| Conditions | Dengue, Severe Dengue, Dengue Fever, Virologically-confirmed Dengue |
| Dates | start 2016-11-01, primary completion 2022-10-31, completion 2023-06-01 (estimated), first posted 2018-03-14, last updated 2023-05-17 |
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This is an observational study for 5 years, and aims to determine the risk of developing dengue among Philippine children who are eligible to receive the dengue vaccine during the DOH mass dengue vaccination, by dengue serostatus at baseline.
This is a cohort study that aims to determine the relative risk of developing virologically-confirmed dengue among Philippine children who are eligible to receive dengue vaccine during the DOH Mass Dengue Vaccination. Additionally, it also aims to determine the relative risk of developing severe and/or hospitalized virologically-confirmed dengue among Philippine children who received the Dengue vaccine, describe the epidemiologic trends and characteristics of virologically-confirmed dengue among these children, and assess the performance of simpler tests such as dried blood spots and serum IgG for the assessment of dengue seroprevalence at the population level. We will enroll children who are residents of selected areas in Region 7, Philippines. Children should be eligible to participate in the Department of Health mass dengue vaccination. They will be prospectively venipunctured for baseline dengue serologic status. The blood samples will be stored for serologic testing using neutralization tests and commercial IgG tests. Children in the cohort will be followed up, and those who present with <5 days of fever will be identified and blood drawn for dengue LAMP and RT-PCR.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cohort | Recruited members of the cohort are children aged 9-14 years old and eligible to receive the dengue vaccine at the time of the initiation of community-based dengue immunization program of the Department of Health. |
Sex: All, ages: 9 Years to 14 Years, accepts healthy volunteers
Inclusion criteria: * Provide signed informed consent and assent (as applicable) * Be a child belonging to the specified age group and resident of the targeted communities of the DOH dengue mass immunization * Be eligible to receive dengue vaccine during the DOH dengue mass immunization in 2017 Exclusion criteria: * Any subject whose parent/guardian refuse to provide informed consent and/or assent * Children who do not belong to the specified age groups and not residents of the targeted communities * Children <9 years old * Children with history of bleeding disorder * Any subject previously enrolled in a dengue vaccine clinical trial