An Epidemiological Surveillance Study to Evaluate the Incidence of Dengue in Brazil

NCT01751139 | Terminated Results

• 1 other identifier: 116606
• Study Type: interventional
• Target: 3,300
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to estimate the incidence of dengue infection in children and adults in geographically distinct locations of Brazil.

Conditions

Dengue

Keywords

Endemic regions; Brazil; Incidence; Surveillance; Dengue

Outcome Measures

Primary Outcomes (1)

• Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed Symptomatic Dengue Infection by Calendar Year

  Incidence rate (IR) of laboratory-confirmed symptomatic dengue infection (lab-conf.) with 95% Confidence Interval (CI) for each year and overall, calculated as the incidence rate per 1000 person-years : numerator = number of all lab-conf. cases reported during the follow-up (FU) period at risk; denominator = total Person-years at risk, i.e. sum of FU periods at risk expressed in years until first Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) confirmed symptomatic dengue infection or subject's withdrawal, whichever came first. Lab-conf. case defined as follows: Dengue virus identification through RT-qPCR on acute serum sample or Dengue virus NS1 positive on acute serum sample through Enzyme-linked Immunosorbent Assay (ELISA) or Anti-Dengue Immunoglobulin type M (IgM) seroconversion between acute and convalescent serum samples through ELISA. Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons.

  At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years

Secondary Outcomes (14)

• Incidence Rate (Per 1000 Person-years) of All Virologically-confirmed Symptomatic Dengue Infection by Calendar Year

  At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years

• Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year

  At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years

• Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year

  At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years

• Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Gender, and Calendar Year

  At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years

• Number of Primary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases

  From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject)

Study Arms (1)

Total Group

OTHER

Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.

Procedure: Blood sample collection; Other: Data collection

Interventions

Blood sample collection PROCEDURE

Blood samples will be collected at each study visit (Day 0, Month 6, Month 12, Month 24, Month 36 and Month 48) and any time during the study that dengue is suspected. Samples collected at scheduled visits will be tested for anti-dengue antibodies. Samples collected at visits for dengue suspicion will be tested for dengue infection diagnosis.

Total Group

Data collection OTHER

Diary logs will be issued to all subjects at every visit, except Month 48 (Day 0, Month 6, Month 12, Month 24, and Month 36), as required. Any completed diary logs will be verified, as applicable. Subjects will be given a diary log in the event of the occurrence of a symptom that may be associated with suspected dengue.

Total Group

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Written, signed or thumb-printed informed consent (and assent when applicable) must be obtained from the subject or subject's parent(s)/legally acceptable representative(s) (LAR(s)). If the subject/subject's parent(s)/LAR(s) are illiterate the consent form will be countersigned by a witness.
• Male or female at least 6 months of age at the time of enrollment.
• Subject and/or subject's parent(s)/LAR(s) who the study staff believes can comply with the requirements of the protocol.
• Subject who plans, at the time of enrollment, to remain at same residence/study area during their study participation period).

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
• Tropical Disease Foundation: collaborator
• Goncalo Moniz Research Center: collaborator
• Evandro Chagas Research Institute, Bio-Manguinhos Technology and Immunology Institute: collaborator

Study Sites (5)

GSK Investigational Site

Manaus, Amazonas, 69040000, Brazil

Location

GSK Investigational Site

Salvador, Estado de Bahia, Brazil

Location

GSK Investigational Site

Natal, Rio Grande do Norte, 59025-050, Brazil

Location

GSK Investigational Site

Campinas, São Paulo, Brazil

Location

GSK Investigational Site

Rio de Janeiro, 21040-900, Brazil

Location

Related Publications (1)

• de Aguiar DF, de Barros ENC, Ribeiro GS, Brasil P, Mourao MPG, Luz K, Aoki FH, Freitas ARR, Calvet GA, Oliveira E, Branco BF, Abreu A, Cheuvart B, Guignard A, de Boer M, Duarte AC, Borges MB, de Noronha TG. A prospective, multicentre, cohort study to assess the incidence of dengue illness in households from selected communities in Brazil (2014-2018). Int J Infect Dis. 2021 Jul;108:443-453. doi: 10.1016/j.ijid.2021.04.062. Epub 2021 Apr 21.

  PMID: 33894353 DERIVED

MeSH Terms

Conditions

Dengue

Interventions

Data Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

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: December 13, 2012
• First Posted: December 17, 2012
• Study Start: February 18, 2014
• Primary Completion: December 20, 2018
• Study Completion: December 20, 2018
• Last Updated: April 27, 2020
• Results First Posted: March 26, 2020

Record last verified: 2020-04

Locations

BR (5)