NCT05153018

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,122

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

October 17, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

November 29, 2021

Last Update Submit

May 22, 2024

Conditions

Keywords

SerologyEpidemiologyVanuatu

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Study Arms (1)

A representative random sample of the population

OTHER

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

Other: Blood collection

Interventions

a 4-mL blood sample collected in a dry tube

A representative random sample of the population

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Blood centers, hospitals, health facilities

Luganville, Vanuatu

Location

Schools

Luganville, Vanuatu

Location

Blood centers, hospitals, health facilities

Port Vila, Vanuatu

Location

Schools

Port Vila, Vanuatu

Location

MeSH Terms

Conditions

Zika Virus InfectionDengueRoss River Virus InfectionChikungunya FeverCOVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, ViralAlphavirus InfectionsTogaviridae InfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Myrielle Dupont-Rouzeyrol, PhD

    Institut Pasteur de Nouvelle-Calédonie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 10, 2021

Study Start

October 17, 2022

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

May 23, 2024

Record last verified: 2024-05

Locations