Assessing the Effectiveness of Sanofi Pasteur's Dengue Vaccine (Dengvaxia) Against Hospitalization and Symptomatic Infection in the State of Parana - Brazil

NCT ID: NCT03960385

Last Updated: 2020-09-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1854 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2020-03-01

Brief Summary

The study seeks to assess the effectiveness of Sanofi Pasteur´s dengue vaccine (Dengvaxia®) according to the age, dose and municipality of residence in five municipalities of Paraná State. Specific objectives include:

• To assess the effectiveness of Dengvaxia® in preventing dengue hospitalization and dengue symptomatic cases.
• To assess the effectiveness of Dengvaxia® in preventing dengue hospitalization and dengue symptomatic cases according in the following age groups 15 to 18 and 19 to 27 years of age in the municipalities of Maringá, Foz de Iguaçu, Londrina, Sarandi and Paranaguá.
• To assess the effectiveness of Dengvaxia® in preventing dengue hospitalization and dengue symptomatic cases in the following age groups 9 to 14 and 28 to 45 years of age in the municipality of Paranaguá.

Detailed Description

The effectiveness of Sanofi Pasteur´s dengue vaccine (Dengvaxia®) according to the age will be assessed in five municipalities of Paraná State - Maringá, Foz de Iguaçu, Londrina, Sarandi and Paranaguá. Any health service located in each of the five municipalities may report a suspected dengue case. However, in all five municipalities, there is a large public emergency service, the UPA. There are currently three UPA in Londrina, two in Maringá and Foz do Iguaҫu and one each in Paranaguá and Sarandi. These facilities are responsible for reporting the majority of suspected dengue cases. In Londrina and Maringá, the private health sector also provides emergency care. The implementation of the study protocol adds a collection of a blood sample for PCR to the existing protocol for addressing suspected dengue cases among individuals within the target vaccination age groups.

The study will count on the activities already carried out by teams of epidemiological surveillance of dengue intensifying the identification of the serotype through the laboratory method RT-PCR (Reverse Transcription Polymerase Chain Reaction) in real time. In addition, the investigators will identify hospitals and health units that attend dengue cases for sample collection, to perform real-time RT-PCR and initial processing of the blood samples collected from the controls.

Conditions

Dengue

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Hospitalized and controls

Age-matched case of hospitalized dengue and non-dengue control

CYD-TDV

Intervention Type: BIOLOGICAL

Dengue vaccine

Outpatient and controls

Age-matched dengue case and non-dengue control

CYD-TDV

Intervention Type: BIOLOGICAL

Dengue vaccine

Interventions

CYD-TDV

Dengue vaccine

Intervention Type: BIOLOGICAL

Other Intervention Names

Dengvaxia®

Eligibility Criteria

Inclusion Criteria

• Individuals living in the municipalities of Sarandi, Paranaguá, Londrina, Maringá or Foz de Iguaçu in the three stages of vaccination
• Individuals with ages ranging from 9 to 44 years for the municipality of Paranaguá and 15 to 27 years for the municipalities of Sarandi, Londrina, Maringá and Foz de Iguaçu
• All participants who are 18 years of age or older sign the informed consent form
• All minors under the age of 18 who sign the consent form and have the consent form signed by a guardian for the minor
• Case with virological isolation of one of the dengue viruses

• Individuals without symptoms for dengue in the 15 days prior to the onset of symptoms of the case
• IgM negative for dengue
• Individuals living in the municipalities of Paranaguá, Londrina, Maringá, Sarandi or Foz de Iguaçu in the three stages of vaccination
• Belongs to the same age group as case
• Participants aged between 9 and 44 years for the municipality of Paranaguá
• Participants 15 to 27 years for the municipalities of Maringá, Foz de Iguaçu, Londrina and Sarandi
• Resides in the same neighborhood as the case, study at the same institution as the case or work in the same company as the case for at least 15 days before the onset of the case symptoms
• Participants that are 18 years of age or older and who sign the informed consent form
• All minors under the age of 18 who sign the consent form and have the consent form signed by a guardian for the minor

Exclusion Criteria

• Those who have been deprived of their liberty (jails, penitentiaries, drug addicts, etc.) within 15 days before the onset of signs and symptoms

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pan American Health Organization

OTHER

Sponsor Role: collaborator

State of Parana/Health Department of Parana

UNKNOWN

Sponsor Role: collaborator

Ministry of Health, Brazil

OTHER_GOV

Sponsor Role: collaborator

Centro de Estudos Augusto Leopoldo Ayrosa Galvão

UNKNOWN

Sponsor Role: collaborator

Albert B. Sabin Vaccine Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denise O Garrett, MD, MSc

Role: STUDY_DIRECTOR

Albert B. Sabin Vaccine Institute

Locations

Augusto Leopoldo Ayrosa Galvão Study Center

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

DNG10042

Identifier Type: -

Identifier Source: org_study_id