Clinical trial NCT02570152: A Cohort Study to Determine the Incidence of Dengue Fever and to Build Capacity for Dengue Vaccine Trials in Dengue-endemic Regions of South Asia
Official title: A Cohort Study to Determine the Incidence of Dengue Fever and to Build Capacity for Dengue Vaccine Trials in Dengue-endemic Regions of South Asia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dengue
Keywords: Dengue
Non-laboratory confirmed dengue (non-LCD)
Acute febrile illness (AFI)
Laboratory confirmed dengue (LCD)
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Ministry of Health, Sri Lanka
First posted: 2015-10-07
Enrollment: 2004
Sex: ALL
Minimum age (years): 6
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the incidence of dengue fever and to build capacity for dengue vaccine trials in dengue-endemic regions of South Asia.

Detailed description: This study aims to estimate the burden of dengue illness in selected sites South Asia and to prepare sites for the conduct of future vaccine efficacy trials.

Operational goals include:

* Build long-term collaboration with sites in dengue-endemic regions of South Asia where the incidence of clinical dengue illness can be studied.
* Establish dengue surveillance cohorts that can be followed long-term.
* Establish operational feasibility of future Phase III studies with regard to recruitment, case capture and sampling procedures.
* Prepare sites for participation in Phase III clinical endpoint studies.

Eligibility criteria: Inclusion Criteria:

* Subject and/or subject's parent(s)/legally acceptable representative(s) (LAR\[s\]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. (e.g., willingness to go to the hospital/clinic for visit\[s\] in case of AFI, able to observe the signs of dengue and to understand how to take and report body temperature, etc.).
* Signed/thumb-printed (and video recorded if required by law) informed consent (and assent if applicable) must be obtained from the subject/subject's parent(s)/LAR(s) at the hospital/clinic or during a home visit. If the subject/subject's parent(s)/LAR(s) are illiterate, the informed consent form (ICF) (or informed assent form \[IAF\] when applicable) will be countersigned by an impartial witness.
* Subject is part of a household with at least one child (aged less than 18 years) and in which informed consent (and assent if applicable) to study participation was obtained from at least one adult and one child.
* Male or female aged between and including 6 months and 50 years at the time of enrolment.
* Subject who plans, at the time of enrolment, to remain at same residence/study area during the two-year study period.

Exclusion Criteria:

* 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 based on investigator's judgement.
* Mental incapacity based on investigator's judgement.

Primary outcomes:
measure: Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Dengue (LCD) Overall, and by Age Group
timeFrame: From first visit to last visit (approximatively 2 years per subject)
Secondary outcomes:
measure: Incidence Rate of Acute Febrile Illness (AFI) Due to Non-Laboratory Confirmed Dengue (Non-LCD) Overall, and by Age Group
timeFrame: From first visit to last visit (approximatively 2 years per subject)
measure: Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 1 Dengue Overall, and by Age Group.
timeFrame: From first visit to last visit (approximatively 2 years per subject)
measure: Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 2 Dengue Overall, and by Age Group
timeFrame: From first visit to last visit (approximatively 2 years per subject)
measure: Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 3 Dengue Overall, and by Age Group
timeFrame: From first visit to last visit (approximatively 2 years per subject)
measure: Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 4 Dengue Overall, and by Age Group
timeFrame: From first visit to last visit (approximatively 2 years per subject)
measure: Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD.
timeFrame: At each day during the 7-day period following the onset of each episode of AFI due to LCD
measure: Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD
timeFrame: At each day during the 7-day period following the onset of each episode of AFI due to LCD
measure: Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD
timeFrame: At each day during the 7-day period following the onset of each episode of AFI due to non-LCD
measure: Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD
timeFrame: At each day during the 7-day period following the onset of each episode of AFI due to non-LCD
measure: Number of Subjects With Serious Adverse Events (SAEs) Related to a Study Procedure
timeFrame: From first visit to last visit (approximatively 2 years per subject)
Other outcomes:
Locations:
city: Colombo
country: Sri Lanka
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Tissera H, Samaraweera P, de Boer M, Gandhi S, Malvaux L, Mehta S, Palihawadana P, Vantomme V, Paris R, Schmidt A. The Burden of Acute Febrile Illness Attributable to Dengue Virus Infection in Sri Lanka: A Single-Center 2-Year Prospective Cohort Study (2016-2019). Am J Trop Med Hyg. 2021 Nov 1;106(1):160-167. doi: 10.4269/ajtmh.21-0604.