DengueNCT03960385
Assessing the Effectiveness of Sanofi Pasteur's Dengue Vaccine (Dengvaxia) Against Hospitalization and Symptomatic Infection in the State of Parana - Brazil
An observational study of Dengue, run by Albert B. Sabin Vaccine Institute at 1 site in Brazil.
Trial 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. Read more about this study
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 44 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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:
Show all 16Show fewer
- Those who have been deprived of their liberty (jails, penitentiaries, drug addicts, etc.) within 15 days before the onset of signs and symptoms
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- CYD-TDV
- Keywords
- Dengue, Dengvaxia, Parana, Sanofi Pasteur, Vaccine Effectiveness, Maringa, Foz de Iguacu, Paranagua, Brazil
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYD-TDVBiological
Also called Dengvaxia®
Dengue vaccine
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized and controls | Age-matched case of hospitalized dengue and non-dengue control Receives: Biological: CYD-TDV | |
| Outpatient and controls | Age-matched dengue case and non-dengue control Receives: Biological: CYD-TDV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dengue symptomatic case
Confirmed (by PCR) case of dengue fever
Measured: Aug 2017 - March 2020
Secondary outcomes (1)
Dengue hospitalization
Hospitalization for severe dengue fever
Measured: Aug 2017 - March 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start1 Aug 2017
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,854 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert B. Sabin Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pan American Health Organization, State of Parana/Health Department of Parana, Ministry of Health, Brazil, Centro de Estudos Augusto Leopoldo Ayrosa Galvão
- Responsible party
- Sponsor
- Investigators
- Denise O Garrett, MD, MSc, Study director, Albert B. Sabin Vaccine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960385
- Sponsor's protocol ID
- DNG10042
- Status last verified
- Sep 2020
- First submitted
- 21 May 2019
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Sanofi Pasteur's Dengue Vaccine (Dengvaxia) Against Hospitalization and Symptomatic Infection in the State of Parana - Brazil
- ClinicalTrials.gov ID
- NCT03960385
- Acronym / sponsor ID
- DNG10042
- Conditions
- Dengue
- Keywords
- Dengue, Dengvaxia, Parana, Sanofi Pasteur, Vaccine Effectiveness, Maringa, Foz de Iguacu, Paranagua
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,854 participants (actual)
- Lead sponsor
- Albert B. Sabin Vaccine InstituteUniversity, hospital or other
- Collaborators
- Pan American Health Organization, State of Parana/Health Department of Parana, Ministry of Health, Brazil, Centro de Estudos Augusto Leopoldo Ayrosa Galvão
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospitalized and controls | – | Biological: CYD-TDVAge-matched case of hospitalized dengue and non-dengue control |
| Outpatient and controls | – | Biological: CYD-TDVAge-matched dengue case and non-dengue control |
Who may qualify
- Ages
- 9 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYD-TDVAlso: Dengvaxia®Dengue vaccine | Biological | Hospitalized and controls, Outpatient and controls |
Primary outcome
Dengue symptomatic case
Time frame: Aug 2017 - March 2020
Confirmed (by PCR) case of dengue fever
1 secondary outcome
Dengue hospitalization
Time frame: Aug 2017 - March 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise O Garrett, MD, MSc study director
Albert B. Sabin Vaccine Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue, run by Albert B. Sabin Vaccine Institute at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dengue symptomatic case (time frame: Aug 2017 - March 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.