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Completed

NCT Number: NCT05153018

Population Immunity AgaiNst mosquitO-borne Diseases in Vanuatu

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood collection

Other

a 4-mL blood sample collected in a dry tube

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Collaborators

  • Ministry of Health, Vanuatu
  • Vanuatu National Hospital

Registry information

Acronym: PIANO

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 10, 2021
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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