Dengue Serostatus Study in the Philippines

NCT03465254 | Unknown DMC

• 1 other identifier: UPM REB 2016-435-01
• Study Type: observational
• Target: 2,996
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dengue; Severe Dengue; Dengue Fever; Virologically-confirmed Dengue

Outcome Measures

Primary Outcomes (1)

• virologically-confirmed dengue (VCD)

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

  5 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Philippines: lead
• Department of Health, Philippines: collaborator
• World Health Organization: collaborator
• Research Institute for Tropical Medicine, Philippines: collaborator
• University of North Carolina: collaborator
• La Jolla Institute for Allergy & Immunology: collaborator
• International Vaccine Institute: collaborator

Related Publications (1)

• 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.

  PMID: 33212030 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Any leftover sera will be used for future studies and stored at UPM-NIH for fifteen (15) years after the end of this study. Future studies using the sera will undergo appropriate ethical reviews as required. After this period, specimens will be destroyed according to local guidelines. Additional consent will be obtained from the parent for storage and future use of these samples. Only the Principal Investigator and designated study personnel will have access to these specimens.

MeSH Terms

Conditions

Dengue; Severe Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• Jacqueline L. Deen, MD

  UPM-NIH, Institute of Child Health and Human Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 14, 2018
• Study Start: November 1, 2016
• Primary Completion: October 31, 2022
• Study Completion: June 1, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05