Arbovirus DiseasePIANONCT05153018
Population Immunity AgaiNst mosquitO-borne Diseases in Vanuatu
A study testing Blood collection in people with Arbovirus Disease and Zika, run by Institut Pasteur at 4 sites in Vanuatu.
Trial summary
The Pacific region is facing several emerging and neglected diseases notably mosquito-borne diseases as malaria or arboviroses among which dengue, Ross River, chikungunya and Zika. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arbovirus Disease, Zika, Dengue
- What is being tested?
- Blood collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,122 participants
- Where
- 4 sitesVanuatu
- Study dates
- 17 Oct 2022to 31 May 2023
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Individuals informed of the research and having given their written consent to participate in the study
- Individuals aged 6 years old or more
- Individuals living in Vanuatu for more than 6 months
- Individuals informed of the research, its objectives and procedure
Who cannot join
- Tourists and people present in Vanuatu for less than 6 months
- Persons intellectually disabled or under guardianship
- Persons suffering from a febrile syndrome
- Missing information related to age or hometown
- Children weighting less than 18 kg
Trial locations and contacts
4 sites in 1 country.
Vanuatu4 sites
Blood centers, hospitals, health facilities
Luganville
Schools
Luganville
Blood centers, hospitals, health facilities
Port Vila
Schools
Port Vila
About this study
The Pacific region is facing several emerging and neglected diseases notably mosquito-borne diseases as malaria or arboviroses among which dengue, Ross River, chikungunya and Zika. These diseases are an important cause of illness and death in the Pacific and the occurrence of arboviruses has increased in the recent years. In humans, these mosquito-borne diseases often have very similar clinical presentations (an acute febrile syndrome often self-limiting). However, these infections can progress to severe and fatal prognosis.
Numerous arboviroses outbreaks and in particular dengue outbreaks have affected Vanuatu for decades. Except for DENV and Zika for which epidemiological and virological data are available for Vanuatu, the knowledge on chikungunya and Ross River circulation is very limited and needs to be defined as both viruses have intensively circulated in the region in the past. Knowledge of the level of immune protection of the population for these mosquito-borne diseases is incomplete. For this purpose, seroprevalence studies that intend to retrospectively look for antibodies (IgG) as an evidence of previous infections by a specific pathogen would be highly informative. Knowing the serological profile of the Vanuatu population for dengue and other arboviruses as Ross River, chikungunya and Zika that could have affected the country in the past would be useful in defining the population likely to be infected by future epidemics.
Read more
COVID-19 pandemic caused by SARS-CoV-2 as caused over 520 million cases since December 2019. Vanuatu has been relatively spared from the pandemic due to the establishment of a sanitary sas involving strict border control. On 04 March 2022, an active COVID-19 case was confirmed at Vila Central Hospital who had no travel history, indicating transmission at community level. Overall, a total of 8487 confirmed cases have been reported since the beginning of 2022.
Local vaccination campaign was initiated in July 2021. A seroprevalence study documenting population immunity to COVID-19 will inform of the breadth of COVID-19 epidemic in Vanuatu, contributing to the evaluation of undetected infections rate. This identification of vulnerable populations will inform local public Health strategies, including targeted vaccination campaigns.
Read the detailed description
The PIANO project is a non-comparative observational prospective cross-sectional descriptive survey on a representative random sample of the population.
The study will be conducted on a 4-mL blood sample collected in a dry tube from 1,200 non-febrile individuals aged older than 6 years old.
The main objective of the current project is to determine the seroprevalence of dengue, Zika, chikungunya, Ross River and COVID-19 in Vanuatu.
- Conditions
- Arbovirus Disease, Zika, Dengue, Ross River, Chikungunya, COVID-19
- Being tested
- Blood collection
- Keywords
- Serology, Epidemiology, Vanuatu
- Medical subject headings
- Zika Virus Infection, Dengue, Ross River Virus Infection, Chikungunya Fever, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionOther
a 4-mL blood sample collected in a dry tube
| Study group | Role | What they receive |
|---|---|---|
| A representative random sample of the population | Other | 1,200 non-febrile individuals aged older than 6 years old Receives: Other: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the seroprevalence of dengue, Zika, chikungunya, Ross River and Covid-19 in Vanuatu.
Exploration of vector-borne diseases seroprevalence in the main Provinces usually involved in outbreaks, the study will be implemented in the main cities of Efate, Santo, Tanna and Malekula Islands namely Port Vila, Luganville, Isangel and Lakatoro along with rural parts connected to the main city by main roads.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start17 Oct 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arbovirus DiseaseStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ministry of Health, Vanuatu, Vanuatu National Hospital
- Responsible party
- Sponsor
- Investigators
- Myrielle Dupont-Rouzeyrol, PhD, Study director, Institut Pasteur de Nouvelle-Calédonie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153018
- Sponsor's protocol ID
- 2020-100
- Acronym
- PIANO
- Status last verified
- May 2024
- First submitted
- 29 Nov 2021
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Immunity AgaiNst mosquitO-borne Diseases in Vanuatu
- ClinicalTrials.gov ID
- NCT05153018
- Acronym / sponsor ID
- PIANO / 2020-100
- Conditions
- Arbovirus Disease, Zika, Dengue, Ross River, Chikungunya, COVID-19
- Keywords
- Serology, Epidemiology, Vanuatu
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,122 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Ministry of Health, Vanuatu, Vanuatu National Hospital
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 10 Dec 2021 (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 Pacific region is facing several emerging and neglected diseases notably mosquito-borne diseases as malaria or arboviroses among which dengue, Ross River, chikungunya and Zika. These diseases are an important cause of illness and death in the Pacific and the occurrence of arboviruses has increased in the recent years. In humans, these mosquito-borne diseases often have very similar clinical presentations (an acute febrile syndrome often self-limiting). However, these infections can progress to severe and fatal prognosis.
Numerous arboviroses outbreaks and in particular dengue outbreaks have affected Vanuatu for decades. Except for DENV and Zika for which epidemiological and virological data are available for Vanuatu, the knowledge on chikungunya and Ross River circulation is very limited and needs to be defined as both viruses have intensively circulated in the region in the past. Knowledge of the level of immune protection of the population for these mosquito-borne diseases is incomplete. For this purpose, seroprevalence studies that intend to retrospectively look for antibodies (IgG) as an evidence of previous infections by a specific pathogen would be highly informative. Knowing the serological profile of the Vanuatu population for dengue and other arboviruses as Ross River, chikungunya and Zika that could have affected the country in the past would be useful in defining the population likely to be infected by future epidemics.
COVID-19 pandemic caused by SARS-CoV-2 as caused over 520 million cases since December 2019. Vanuatu has been relatively spared from the pandemic due to the establishment of a sanitary sas involving strict border control. On 04 March 2022, an active COVID-19 case was confirmed at Vila Central Hospital who had no travel history, indicating transmission at community level. Overall, a total of 8487 confirmed cases have been reported since the beginning of 2022.
Local vaccination campaign was initiated in July 2021. A seroprevalence study documenting population immunity to COVID-19 will inform of the breadth of COVID-19 epidemic in Vanuatu, contributing to the evaluation of undetected infections rate. This identification of vulnerable populations will inform local public Health strategies, including targeted vaccination campaigns.
Detailed description
The PIANO project is a non-comparative observational prospective cross-sectional descriptive survey on a representative random sample of the population.
The study will be conducted on a 4-mL blood sample collected in a dry tube from 1,200 non-febrile individuals aged older than 6 years old.
The main objective of the current project is to determine the seroprevalence of dengue, Zika, chikungunya, Ross River and COVID-19 in Vanuatu.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A representative random sample of the population | Other | Other: Blood collection1,200 non-febrile individuals aged older than 6 years old |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals informed of the research and having given their written consent to participate in the study
- Individuals aged 6 years old or more
- Individuals living in Vanuatu for more than 6 months
- Individuals informed of the research, its objectives and procedure
Key exclusion criteria (5 listed)
- Tourists and people present in Vanuatu for less than 6 months
- Persons intellectually disabled or under guardianship
- Persons suffering from a febrile syndrome
- Missing information related to age or hometown
- Children weighting less than 18 kg
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 |
|---|---|---|
| Blood collectiona 4-mL blood sample collected in a dry tube | Other | A representative random sample of the population |
Primary outcome
Determination of the seroprevalence of dengue, Zika, chikungunya, Ross River and Covid-19 in Vanuatu.
Time frame: 1 year
Exploration of vector-borne diseases seroprevalence in the main Provinces usually involved in outbreaks, the study will be implemented in the main cities of Efate, Santo, Tanna and Malekula Islands namely Port Vila, Luganville, Isangel and Lakatoro along with rural parts connected to the main city by main roads.
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 23 May 2024.
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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.
Myrielle Dupont-Rouzeyrol, PhD study director
Institut Pasteur de Nouvelle-Calédonie
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood collection in people with Arbovirus Disease and Zika, run by Institut Pasteur at 4 sites in Vanuatu.
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 4 inclusion and 5 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 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Vanuatu. 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?
Determination of the seroprevalence of dengue, Zika, chikungunya, Ross River and Covid-19 in Vanuatu. (time frame: 1 year). 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 23 May 2024.