PIANO: Population Immunity AgaiNst mosquitO-borne Diseases in Vanuatu

Sponsor
Institut Pasteur (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05153018
Collaborator
Ministry of Health of Vanuatu (Other), Vanuatu National Hospital (Other)
1,200
4
1
6.5
300
46.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood collection
N/A

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 and Ross River in Vanuatu.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Population Immunity AgaiNst mosquitO-borne Diseases in Vanuatu
Anticipated Study Start Date :
Sep 15, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: A representative random sample of the population

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

Other: Blood collection
a 4-mL blood sample collected in a dry tube

Outcome Measures

Primary Outcome Measures

  1. Determination of the seroprevalence of dengue, Zika, chikungunya and Ross River in Vanuatu. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Blood centers, hospitals, health facilities Luganville Vanuatu
2 Schools Luganville Vanuatu
3 Blood centers, hospitals, health facilities Port-Vila Vanuatu
4 Schools Port-Vila Vanuatu

Sponsors and Collaborators

  • Institut Pasteur
  • Ministry of Health of Vanuatu
  • Vanuatu National Hospital

Investigators

  • Study Director: Myrielle Dupont-Rouzeyrol, PhD, Institut Pasteur de Nouvelle-Calédonie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Pasteur
ClinicalTrials.gov Identifier:
NCT05153018
Other Study ID Numbers:
  • 2020-100
First Posted:
Dec 10, 2021
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut Pasteur
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2022