Arbovirus InfectionsEPI-ARBONCT03210363
Sero-epidemiology of Priority Arboviruses in French Guiana
A study testing Human Biological samples in people with Arbovirus Infections, run by Institut Pasteur at 1 site in France.
Trial summary
Dengue is an important public health problem despite the efforts of local health authorities to mitigate the impact of epidemics and the epidemiology of dengue evolved from an endemo-epidemic to a hyper-endemic state. Read more about this study
- Who is it for?
- Ages 2 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Arbovirus Infections
- What is being tested?
- Human Biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,697 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Guiana resident for at least 6 months and present during the entire study period
- Age between 2 and 75 years old
Who cannot join
- Subject under guardianship or deprived of liberty by judicial decision
- Subject with any pathology or health problem not compatible with blood sampling
Trial locations and contacts
1 site in 1 country.
About this study
Dengue is an important public health problem despite the efforts of local health authorities to mitigate the impact of epidemics and the epidemiology of dengue evolved from an endemo-epidemic to a hyper-endemic state. In late 2013, the first local transmission of chikungunya virus in the Americas was identified in Caribbean countries and territories including French Guiana. Rapidly, more than 16,000 suspected local Health authorities had reported cases. In May 2015, the Pan American Health Organization (PAHO) issued an alert regarding the first confirmed Zika virus infections in Brazil. The emergence of Zika virus in South America led to a rapid spread throughout South and Central America, reaching French Guiana in December 2015. With the increasing frequency of epidemics related to arbovirus and the resulting health, social, and economic impacts of dengue, the surveillance of arbovirus have become social, political, and public health challenges that require specific and non-available immune status information.
Read the detailed description
French Guiana is a 250,000 inhabitant's French overseas department located in South America, the epidemiology of arboviruses has recently evolved and marked by important outbreaks.
Dengue remains an important public health problem despite the efforts of local health authorities to mitigate the impact of epidemics and the epidemiology of dengue evolved from an endemo-epidemic to a hyper-endemic state. In late 2013, the first local transmission of chikungunya virus in the Americas was identified in Caribbean countries and territories including French Guiana. Rapidly, more than 16,000 suspected local Health authorities had reported cases. In May 2015, the Pan American Health Organization (PAHO) issued an alert regarding the first confirmed Zika virus infections in Brazil. The emergence of Zika virus in South America led to a rapid spread throughout South and Central America, reaching French Guiana in December 2015. With the increasing frequency of epidemics related to arbovirus and the resulting health, social, and economic impacts of dengue, the surveillance of arbovirus have become social, political, and public health challenges that require specific and non-available immune status information.
- Conditions
- Arbovirus Infections
- Being tested
- Human Biological samples
- Medical subject headings
- Arbovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Biological samplesOther
Blood sample
| Study group | Role | What they receive |
|---|---|---|
| Guiana population | Experimental | Human Biological samples from Guiana population :
Two serum tubes of blood will be collected Receives: Other: Human Biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dengue, chikungunya, zika Antibodies detection by multiplex serologic tests
Description of the virological status of individuals by Mutiplex detection of antibodies directed against dengue, chikungunya and zika arboviruses.
Measured: 2 years
Secondary outcomes (1)
Seroprevalence by area and age
Estimatation of the frequency of Dengue, Chikungunya and zika infections among the general population of French Guiana by geographical area and by age class
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start9 Jun 2017
- Primary completion21 Nov 2017
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arbovirus InfectionsStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,697 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claude Flamand, Principal investigator, Institut Pasteur de la Guyane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210363
- Sponsor's protocol ID
- 2016-073
- Acronym
- EPI-ARBO
- Status last verified
- Sep 2020
- First submitted
- 16 Jun 2017
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sero-epidemiology of Priority Arboviruses in French Guiana
- ClinicalTrials.gov ID
- NCT03210363
- Acronym / sponsor ID
- EPI-ARBO / 2016-073
- Conditions
- Arbovirus Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,697 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 21 Nov 2017 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 6 Jul 2017 (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.
Dengue is an important public health problem despite the efforts of local health authorities to mitigate the impact of epidemics and the epidemiology of dengue evolved from an endemo-epidemic to a hyper-endemic state. In late 2013, the first local transmission of chikungunya virus in the Americas was identified in Caribbean countries and territories including French Guiana. Rapidly, more than 16,000 suspected local Health authorities had reported cases. In May 2015, the Pan American Health Organization (PAHO) issued an alert regarding the first confirmed Zika virus infections in Brazil. The emergence of Zika virus in South America led to a rapid spread throughout South and Central America, reaching French Guiana in December 2015. With the increasing frequency of epidemics related to arbovirus and the resulting health, social, and economic impacts of dengue, the surveillance of arbovirus have become social, political, and public health challenges that require specific and non-available immune status information.
Detailed description
French Guiana is a 250,000 inhabitant's French overseas department located in South America, the epidemiology of arboviruses has recently evolved and marked by important outbreaks.
Dengue remains an important public health problem despite the efforts of local health authorities to mitigate the impact of epidemics and the epidemiology of dengue evolved from an endemo-epidemic to a hyper-endemic state. In late 2013, the first local transmission of chikungunya virus in the Americas was identified in Caribbean countries and territories including French Guiana. Rapidly, more than 16,000 suspected local Health authorities had reported cases. In May 2015, the Pan American Health Organization (PAHO) issued an alert regarding the first confirmed Zika virus infections in Brazil. The emergence of Zika virus in South America led to a rapid spread throughout South and Central America, reaching French Guiana in December 2015. With the increasing frequency of epidemics related to arbovirus and the resulting health, social, and economic impacts of dengue, the surveillance of arbovirus have become social, political, and public health challenges that require specific and non-available immune status information.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guiana population | Experimental | Other: Human Biological samplesHuman Biological samples from Guiana population : Two serum tubes of blood will be collected |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Guiana resident for at least 6 months and present during the entire study period
- Age between 2 and 75 years old
Key exclusion criteria (2 listed)
- Subject under guardianship or deprived of liberty by judicial decision
- Subject with any pathology or health problem not compatible with blood sampling
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 |
|---|---|---|
| Human Biological samplesBlood sample | Other | Guiana population |
Primary outcome
Dengue, chikungunya, zika Antibodies detection by multiplex serologic tests
Time frame: 2 years
Description of the virological status of individuals by Mutiplex detection of antibodies directed against dengue, chikungunya and zika arboviruses.
1 secondary outcome
Seroprevalence by area and age
Time frame: 2 years
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 14 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Arbovirus Infections
Active, not recruitingPhase 3
A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population
Yellow Fever Immunization
RecruitingObservational study
Screening for LID Clinical Studies Unit Healthy Volunteer Protocols
Zika, Influenza
RecruitingObservational study
FINtick - a Prospective Multicenter Study on Tick-borne Infections in Finland
Tick Borne Encephalitis (TBE), Lyme Borreliosis
RecruitingPhase 1
Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
Healthy Volunteers, Dengue
Active, not recruiting
A Controlled Human Infection Model of Dengue
Dengue
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.
Claude Flamand principal investigator
Institut Pasteur de la Guyane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human Biological samples in people with Arbovirus Infections, run by Institut Pasteur at 1 site in France.
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 2 inclusion and 2 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 14 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 France. 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, chikungunya, zika Antibodies detection by multiplex serologic tests (time frame: 2 years). 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 14 Sep 2020.