Clinical trial NCT03465254: Dengue Serostatus Study in the Philippines
Official title: Effect of Baseline Dengue Serostatus Among Tetravalent Dengue Vaccine CYDTDV (Dengvaxia®) Recipients on Subsequent Virologically Confirmed Dengue in the Philippines
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dengue
Severe Dengue
Dengue Fever
Virologically-confirmed Dengue
Lead sponsor: University of the Philippines
Sponsor class: OTHER
Collaborators: name: Department of Health, Philippines
name: World Health Organization
name: Research Institute for Tropical Medicine, Philippines
name: University of North Carolina
name: La Jolla Institute for Allergy & Immunology
name: International Vaccine Institute
First posted: 2018-03-14
Enrollment: 2996
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children in selected study areas in Region 7, aged 9-14 years old who are considered eligible to be included in the DOH dengue mass vaccination

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: virologically-confirmed dengue (VCD)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UPM-NIH, Institute of Child Health and Human Development
name: Jacqueline L. Deen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lopez AL, Adams C, Ylade M, Jadi R, Daag JV, Molloy CT, Agrupis KA, Kim DR, Silva MW, Yoon IK, White L, Deen J, de Silva AM. Determining dengue virus serostatus by indirect IgG ELISA compared with focus reduction neutralisation test in children in Cebu, Philippines: a prospective population-based study. Lancet Glob Health. 2021 Jan;9(1):e44-e51. doi: 10.1016/S2214-109X(20)30392-2. Epub 2020 Nov 16.