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

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.

Study Overview

• Status: Completed
• Conditions: Dengue
• Intervention / Treatment: Biological: CYD-TDV

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.

• Study Type: Observational
• Enrollment (Actual): 1854

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Augusto Leopoldo Ayrosa Galvão Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 42 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The effectiveness of Sanofi Pasteur´s dengue vaccine (Dengvaxia®) according to age will be assessed in 5 municipalities of Paraná State - Maringá, Foz de Iguaçu, Londrina, Sarandi and Paranaguá. The municipalities were chosen because they are of medium size and have a history of dengue. The first 4 present a historical series of occurrence of dengue since the 1990s, while in Paranaguá the history of the disease is more recent. Any health service located in each of the five municipalities may report a suspected dengue case. In all five municipalities, there is a large public emergency service, the UPA, which is responsible for reporting the majority of suspected dengue cases. In Londrina and Maringá, the private health sector also provides emergency care.

Description

Inclusion criteria for cases:

• 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

Case 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

Inclusion criteria for controls:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hospitalized and controls; Age-matched case of hospitalized dengue and non-dengue control	Biological: CYD-TDV; Dengue vaccine; Other Names: Dengvaxia®
Outpatient and controls; Age-matched dengue case and non-dengue control	Biological: CYD-TDV; Dengue vaccine; Other Names: Dengvaxia®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dengue symptomatic case	Confirmed (by PCR) case of dengue fever	Aug 2017 - March 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dengue hospitalization	Hospitalization for severe dengue fever	Aug 2017 - March 2020

Collaborators and Investigators

• Sponsor: Albert B. Sabin Vaccine Institute
• Collaborators: Pan American Health Organization; State of Parana/Health Department of Parana; Ministry of Health of Brazil; Centro de Estudos Augusto Leopoldo Ayrosa Galvão
• Investigators: Study Director: Denise O Garrett, MD, MSc, Albert B. Sabin Vaccine Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: May 21, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Dengue; Brazil; Vaccine Effectiveness; Dengvaxia; Parana; Sanofi Pasteur; Maringa; Foz de Iguacu; Paranagua
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Dengue
• Other Study ID Numbers: DNG10042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No