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

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ClinicalTrials.gov Identifier: NCT03960385
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Collaborators:
Pan American Health Organization
State of Parana/Health Department of Parana
Ministry of Health of Brazil
Centro de Estudos Augusto Leopoldo Ayrosa Galvão
Information provided by (Responsible Party):
Albert B. Sabin Vaccine Institute

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.

Condition or disease Intervention/treatment
Dengue 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.


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Study Type : Observational
Estimated Enrollment : 2130 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Assessing the Effectiveness of Sanofi Pasteur's Dengue Vaccine (Dengvaxia) Against Hospitalization and Symptomatic Infection in the State of Parana - Brazil
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

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

Outpatient and controls
Age-matched dengue case and non-dengue control
Biological: CYD-TDV
Dengue vaccine
Other Name: Dengvaxia®




Primary Outcome Measures :
  1. Dengue symptomatic case [ Time Frame: Aug 2017 - March 2020 ]
    Confirmed (by PCR) case of dengue fever


Secondary Outcome Measures :
  1. Dengue hospitalization [ Time Frame: Aug 2017 - March 2020 ]
    Hospitalization for severe dengue fever



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   9 Years to 44 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960385


Contacts
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Contact: Denise O Garrett, MD, MSc 202-842-5025 denise.garrett@sabin.org

Locations
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Brazil
Augusto Leopoldo Ayrosa Galvão Study Center Recruiting
São Paulo, Brazil
Contact: Cassio De Moraes         
Sponsors and Collaborators
Albert B. Sabin Vaccine Institute
Pan American Health Organization
State of Parana/Health Department of Parana
Ministry of Health of Brazil
Centro de Estudos Augusto Leopoldo Ayrosa Galvão
Investigators
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Study Director: Denise O Garrett, MD, MSc Albert B. Sabin Vaccine Institute

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Responsible Party: Albert B. Sabin Vaccine Institute
ClinicalTrials.gov Identifier: NCT03960385     History of Changes
Other Study ID Numbers: DNG10042
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Albert B. Sabin Vaccine Institute:
Dengue
Dengvaxia
Parana
Sanofi Pasteur
Vaccine Effectiveness
Maringa
Foz de Iguacu
Paranagua
Brazil
Additional relevant MeSH terms:
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Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Vaccines
Immunologic Factors
Physiological Effects of Drugs