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Dengue Serostatus Study in the Philippines

Sponsor
University of the Philippines (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03465254
Collaborator
Department of Health, Philippines (Other), World Health Organization (Other), Research Institute for Tropical Medicine, Philippines (Other), University of North Carolina (Other), La Jolla Institute for Allergy & Immunology (Other), International Vaccine Institute (Other)
2,996
Enrollment
71
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2996 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effect of Baseline Dengue Serostatus Among Tetravalent Dengue Vaccine CYDTDV (Dengvaxia®) Recipients on Subsequent Virologically Confirmed Dengue in the Philippines
    Actual Study Start Date :
    Nov 1, 2016
    Anticipated Primary Completion Date :
    Oct 1, 2022
    Anticipated Study Completion Date :
    Oct 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. virologically-confirmed dengue (VCD) [5 years]

      The primary outcome measure is virologically confirmed dengue by RT-PCR

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    9 Years to 14 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of the Philippines
    • 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

    Investigators

    • Principal Investigator: Jacqueline L. Deen, MD, UPM-NIH, Institute of Child Health and Human Development

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of the Philippines
    ClinicalTrials.gov Identifier:
    NCT03465254
    Other Study ID Numbers:
    • UPM REB 2016-435-01
    First Posted:
    Mar 14, 2018
    Last Update Posted:
    Apr 20, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Dengue
    Severe Dengue

    Study Results

    No Results Posted as of Apr 20, 2020