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Population Immunity AgaiNst mosquitO-borne Diseases in Vanuatu (PIANO)

Primary Purpose

Arbovirus Disease, Zika, Dengue

Status
Recruiting
Phase
Not Applicable
Locations
Vanuatu
Study Type
Interventional
Intervention
Blood collection
Sponsored by
Institut Pasteur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Arbovirus Disease focused on measuring Serology, Epidemiology, Vanuatu

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Blood centers, hospitals, health facilitiesRecruiting
  • SchoolsRecruiting
  • Blood centers, hospitals, health facilitiesRecruiting
  • SchoolsRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

A representative random sample of the population

Arm Description

1,200 non-febrile individuals aged older than 6 years old

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 29, 2021
Last Updated
November 8, 2022
Sponsor
Institut Pasteur
Collaborators
Ministry of Health of Vanuatu, Vanuatu National Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05153018
Brief Title
Population Immunity AgaiNst mosquitO-borne Diseases in Vanuatu
Acronym
PIANO
Official Title
Population Immunity AgaiNst mosquitO-borne Diseases in Vanuatu
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Pasteur
Collaborators
Ministry of Health of Vanuatu, Vanuatu National Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arbovirus Disease, Zika, Dengue, Ross River, Chikungunya, COVID-19
Keywords
Serology, Epidemiology, Vanuatu

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A representative random sample of the population
Arm Type
Other
Arm Description
1,200 non-febrile individuals aged older than 6 years old
Intervention Type
Other
Intervention Name(s)
Blood collection
Intervention Description
a 4-mL blood sample collected in a dry tube
Primary Outcome Measure Information:
Title
Determination of the seroprevalence of dengue, Zika, chikungunya, Ross River and Covid-19 in Vanuatu.
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myrielle Dupont-Rouzeyrol, Ph
Phone
+687 27 75 30
Email
mdupont@pasteur.nc
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Inizan, PhD
Phone
+687 27 26 66
Email
cinizan@pasteur.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myrielle Dupont-Rouzeyrol, PhD
Organizational Affiliation
Institut Pasteur de Nouvelle-Calédonie
Official's Role
Study Director
Facility Information:
Facility Name
Blood centers, hospitals, health facilities
City
Luganville
Country
Vanuatu
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roger Jimmy, MD
Email
rojimmy@vanuatu.gov.vu
Facility Name
Schools
City
Luganville
Country
Vanuatu
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roger Jimmy, MD
Email
rojimmy@vanuatu.gov.vu
Facility Name
Blood centers, hospitals, health facilities
City
Port-Vila
Country
Vanuatu
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wesley Donald, MD
Email
wdonald@vanuatu.gov.vu
Facility Name
Schools
City
Port-Vila
Country
Vanuatu
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wesley Donald, MD
Email
wdonald@vanuatu.gov.vu

12. IPD Sharing Statement

Learn more about this trial

Population Immunity AgaiNst mosquitO-borne Diseases in Vanuatu

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