Population Immunity AgaiNst mosquitO-borne Diseases in Vanuatu

NCT ID: NCT05153018

Last Updated: 2024-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-17

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Arbovirus Disease Zika Dengue Ross River Chikungunya COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A representative random sample of the population

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

Group Type OTHER

Blood collection

Intervention Type OTHER

a 4-mL blood sample collected in a dry tube

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood collection

a 4-mL blood sample collected in a dry tube

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ministry of Health of Vanuatu

UNKNOWN

Sponsor Role collaborator

Vanuatu National Hospital

UNKNOWN

Sponsor Role collaborator

Institut Pasteur

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Myrielle Dupont-Rouzeyrol, PhD

Role: STUDY_DIRECTOR

Institut Pasteur de Nouvelle-Calédonie

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Blood centers, hospitals, health facilities

Luganville, , Vanuatu

Site Status

Schools

Luganville, , Vanuatu

Site Status

Blood centers, hospitals, health facilities

Port Vila, , Vanuatu

Site Status

Schools

Port Vila, , Vanuatu

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Vanuatu

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-100

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Malaria Genetic Surveillance
NCT03384498 UNKNOWN