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

NCT ID: NCT02570152

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2004 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2019-06-28

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.

Conditions

Dengue

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

AFI Group

Population living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years will be considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consent (and assent if applicable) to participate in the study.

Group Type: EXPERIMENTAL

Blood sample collection

Intervention Type: PROCEDURE

Blood samples will be collected during the Suspected Dengue First Visit. All study subjects with AFI (fever \[body temperature ≥ 38°C/≥ 100.4°F\] on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart) should be seen at a designated study hospital/clinic by the study physician. The Suspected Dengue First Visit should be scheduled within 7 days from the onset of fever (Days 2-7) and should ideally take place on the second day of fever (Day 2).

Interventions

Blood sample collection

Blood samples will be collected during the Suspected Dengue First Visit. All study subjects with AFI (fever \[body temperature ≥ 38°C/≥ 100.4°F\] on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart) should be seen at a designated study hospital/clinic by the study physician. The Suspected Dengue First Visit should be scheduled within 7 days from the onset of fever (Days 2-7) and should ideally take place on the second day of fever (Day 2).

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, Sri Lanka

OTHER_GOV

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Colombo, , Sri Lanka

Countries

Sri Lanka

References

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.

Reference Type: DERIVED

PMID: 34724624 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

200274

Identifier Type: -

Identifier Source: org_study_id