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A cohort study to assess the burden of dengue illness in household members from selected communities in Southeast Asia and Latin America.

PHRR171103-001716

200318 (EPI-DENGUE-007 BOD)

20150928122307

A prospective, multi-centre, cohort study to assess the burden of dengue illness in household members (aged 6 months to 50 years) from selected communities in Southeast Asia and Latin America

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. The study will describe the immune profile of study participants against DENV and possibly other flaviviruses at enrolment.
 
This study is also seeking to maintain/set up febrile illness surveillance and operational capacity in sites in countries of Latin America and Southeast Asia for the targeted study
population (6 months to 50 years) with the perspective of preparing these sites for future dengue vaccine efficacy studies.
 
Approximately, 1750 subjects are expected to be enrolled into this study with about 300-500 subjects expected per study site. Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia will be part of this study.
 
•Type of design: Prospective, multicentre, householdbased, cohort study/surveillance study.
 
•Study population: 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 will comprise household members. The study population should include between 30% and 50% of adults (aged 18 years or above) per site.
 
•Recruitment: The appropriate recruitment strategy will be selected by each participating site. Two approaches may be considered: a school-based approach and a community-based approach without school involvement.
 
•Duration of longitudinal follow-up and number of visits: Each subject will have 3 scheduled visits at enrolment, at Month 12 and a conclusion visit at Month 24. The Month 12 and Month 24 visits may occur via a telephone contact for the Mexican site. The study duration will be 24 months for each participating site. In countries with marked seasonality, the recruitment period would preferably occur outside the period of peak incidence of dengue, based on the local epidemiology of dengue in the past years and preferentially outside the holiday period (if the investigator believes that families are more likely to leave the study area during this period). These periods will be described for each site and may be modified upon mutual agreement between the investigator and the central study team based on available epidemiological information.
 
•Type of study: self-contained.
 
•Data collection: Electronic Case Report Form (eCRF).
 
•Duration of the study: Because of differences in local regulations, dengue seasonality and holiday period between countries, the recruitment period will be staggered. However, to facilitate site activities, sites will target to have all the subjects recruited in a 3-month period. For each subject, the study duration will be 24 months.
 
•Epoch 001: Prospective data collection starting at Visit 1 (Day 0) and ending at the conclusion visit (Month 24).

Regime Classification Priority
2017 - 2022 Holistic approaches to health and wellness Access to essential medical products, vaccines and technologies
Start Date Duration in Months Target Completion Date Actual Completion Date
2017-08-30 34 2020-06-30 2018-12-14

Completed

Institution Classification Region LTO #
GlaxoSmithKline Biologicals Private Business Belgium Not applicable
Institution Classification Region LTO #
Quintiles Philippines, Inc. Private Business NCR CDRR-NCR-CRO-02
Institution Region
GlaxoSmithKline Biologicals Belgium
Name E-Mail Institution and Institution Address
Elena Lam QMNL.HealthRegistrymailbox@quintiles.com Unit A, 7th Floor, 8 Rockwell Building Hidalgo Drive, Rockwell Business Center Makati 1210 Philippines
Name E-Mail Institution and Institution Address
Schedar Umandap Schedar.Umandap@quintiles.com Unit A, 7th Floor, 8 Rockwell Building Hidalgo Drive, Rockwell Business Center Makati 1210 Philippines
Name Expertise Affiliation
Maria Rosario Z. Capeding, MD Pediatrics Research Institute for Tropical Medicine
Project Location Institutional Ethics Review Board
Research Institute for Tropical Medicine Research Institute for Tropical Medicine Institutional Review Board

Dengue

To estimate the overall incidence rate of reversetranscriptase quantitative polymerase chain reaction (RTqPCR)-confirmed symptomatic DENV infection in a multi-centre cohort of household members aged 6 months to 50 years.

To estimate the incidence rate of virologically confirmed (through RT-qPCR or NS1) and probable (based on serological evidence) symptomatic DENV cases, separately and combined - by age, gender, site, serotype (if applicable) and anti-DENV IgG serological status at enrolment.
 
To estimate the prevalence of anti-DENV immunoglobulin G (IgG) antibodies against dengue in the study population, overall and by age and site (at enrolment), for all participants and among dengue cases (confirmed and probable).
 
To describe clinical presentations of dengue cases (confirmed and probable).

Completed

  • Philippines

Clinical Trial

200318 (EPI-DENGUE-007 BOD)

20150928122307

0000-00-00

0000-00-00

500

500

Not applicable

2017-08-30

Inclusion criteria for subject enrollment:

All subjects must satisfy AA the following criteria at study entry:

Written and signed informed consent (and assent if the subject is below the legal age of consent) obtained from the subject/from the 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 mos. and 50 years of age at the time of enrollment (Subject 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 visits 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 enrollment to remain at the same residence/study area during the one or two 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.

Exclusion criteria for subjects enrollment:

The following criteria should be checked at the time of study entry. If any exclusion criterion applies, the subject must not be included in the study:

Child in care

Please refer to the glossary of terms for the definition of 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 the investigator's judgement

Terminal illness or severe mental incapacity

Observational

Unspecified

Unspecified

None

Unspecified

Unspecified

Unspecified

Unspecified

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. The results will inform the design of future clinical trials, supporting decision making on target age groups and stratification, sample size estimation, recruitment method. the study will describe the population pre-existing immune status to dengue and other relevant flaviviruses reflecting past exposure. It will explore spatial and temporal characteristics of dengue transmission in the selected communities. The data generated may support modelling work to assess the impact of heterogeneity (heterogeneity of exposure, heterogeneity of individual response influenced by the preexisting immune status) on the outcomes of an efficacy trial.

In addition, the study may shed light of other infectious aetiologies than dengue in patients with febrile illness episodes. 

This study is also seeking to maintain/set up febrile illness surveillance and operational capacity in sites in countries of Latin America and Southeast Asia for the targeted study population (6 months to 50 years) with the perspective of preparing these sites for the future dengue vaccine efficacy and effectiveness studies. 

 

Phase IV

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