This Study Will Describe the Burden of DENgue Fever Virus (DENV) Illness Among Household Members Aged 6 Months to 50 Years of Selected Communities in Latin America and Southeast Asia

NCT02766088 | Terminated Results

• 1 other identifier: 200318
• Study Type: interventional
• Target: 1,750
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this study is to describe the burden of DENV illness among household members aged 6 months to 50 years of selected communities in Latin America and Southeast Asia.

Conditions

Dengue; Dengue Vaccines

Keywords

Dengue; Household; Southeast Asia; Latin America; Surveillance

Outcome Measures

Primary Outcomes (1)

• Incidence Percentage of Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-qPCR) Confirmed Symptomatic Dengue Infection During the Study Period by Study Site

  Incidence percentage of RT-qPCR confirmed symptomatic dengue infection was expressed as percentage of subjects = (n \[number of subjects with at least one event reported during the study period \]/N \[number of subjects in the population\]) X 100. The 95% Wald CI was calculated. Clustering effect was not retained because equal or less than 1. RT-qPCR confirmed symptomatic case = suspected dengue case (SDC) confirmed by RT-qPCR. See SDC definition in outcome 5.

  From Day 0 to Month 24 (study end)

Secondary Outcomes (9)

• Number of Subjects With DENV-type Specific Confirmed Symptomatic DENV Infection

  From Day 0 to Month 24 (study end)

• Incidence Proportion of Virologically Confirmed Symptomatic Dengue Infection During the Study Period in Mexico

  From Day 0 to Month 24 (study end)

• Incidence Percentage of Virologically Confirmed Symptomatic Dengue Infection During the Study Period in the Philippines.

  From Day 0 to Month 24 (study end)

• Incidence Proportion of Probable Symptomatic Dengue Infection During the Study Period.

  From Day 0 to Month 24 (study end)

• Proportion of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category.

  At Day 0

Study Arms (1)

Total Group

EXPERIMENTAL

Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches might be considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.

Procedure: Blood sample collection

Interventions

Blood sample collection PROCEDURE

All participants will have an enrolment visit with collection of a blood sample and a termination contact/visit. Participants or their parents/guardians will be contacted weekly or every two weeks to monitor the occurrence of febrile episodes. Additional visits will be made if febrile episodes occur. In case of dengue suspicion, a blood sample will be collected.

Total Group

Eligibility Criteria

• Age: 6 Months - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Written and signed informed consent (and assent if the subject is below the legal age of consent) obtained from the subject/from subject's parent(s)/LAR(s). For a subject below the legal age of consent is, his/her signature will be obtained on the informed assent form, if applicable.
• A male or female between, and including 6 months and 50 years of age at the time of enrolment (Subjects become ineligible on their 51st birthday).
• Subject and/or the subject's parent(s)/LAR(s) who the investigator believes can comply with the requirements of the protocol (e.g., willingness to go to the hospital/healthcare centre for visit(s) in case of acute febrile illness, able to observe the signs of dengue and to understand how to take and report body temperature, etc).
• Subject who plans, at the time of enrolment, to remain at same residence/study area during the one or two year study period (as applicable).
• Household should be reachable by phone (residence phone or mobile phone). Note: Pregnant or lactating female or female planning to become pregnant can be recruited into the study.

You may not qualify if:

• Child in care.
• Participation (current or planned) in another epidemiological study or in a clinical trial that would conflict with the current study, based on investigator's judgement.
• Terminal illness or severe mental incapacity.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Zapopan, Jalisco, 45170, Mexico

Location

GSK Investigational Site

City of Muntinlupa, 1781, Philippines

Location

Related Publications (2)

• DeAntonio R, Amaya-Tapia G, Ibarra-Nieto G, Huerta G, Damaso S, Guignard A, de Boer M. Incidence of dengue illness in Mexican people aged 6 months to 50 years old: A prospective cohort study conducted in Jalisco. PLoS One. 2021 May 5;16(5):e0250253. doi: 10.1371/journal.pone.0250253. eCollection 2021.

  PMID: 33951076 BACKGROUND

• Capeding MR, de Boer M, Damaso S, Guignard A. Assessing the burden of dengue among household members in Alaminos, Laguna, the Philippines: a prospective cohort study. Asian Biomed (Res Rev News). 2021 Oct 29;15(5):213-222. doi: 10.2478/abm-2021-0027. eCollection 2021 Oct.

  PMID: 37551324 BACKGROUND

MeSH Terms

Conditions

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

Limitations and Caveats

Analyses by season/year, age, gender, serotype and dengue serological status at beginning of analysis period were not performed due to low number of virologically confirmed or probable symptomatic dengue infection reported during the study period.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

gskclinicalhd@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: May 9, 2016
• Study Start: July 14, 2016
• Primary Completion: December 14, 2018
• Study Completion: December 14, 2018
• Last Updated: March 15, 2024
• Results First Posted: April 27, 2020

Record last verified: 2024-02

Locations

ME (1); PH (1)