Population Immunity AgaiNst mosquitO-borne Diseases in Vanuatu

COVID-19 Clinical Trial

— PIANO  

Official title:

Population Immunity AgaiNst mosquitO-borne Diseases in Vanuatu

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05153018
• Other study ID #: 2020-100
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: August 2022
• Source: Institut Pasteur
• Contact: Myrielle Dupont-Rouzeyrol, Ph
• Phone: +687 27 75 30
• Email: mdupont[@]pasteur.nc
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chikungunya
• COVID-19
• Dengue
• Vector Borne Diseases
• Zika

Intervention

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

Locations

Country	Name	City	State
Vanuatu	Blood centers, hospitals, health facilities	Luganville
Vanuatu	Schools	Luganville
Vanuatu	Blood centers, hospitals, health facilities	Port-Vila
Vanuatu	Schools	Port-Vila

Sponsors (3)

Lead Sponsor	Collaborator
Institut Pasteur	Ministry of Health of Vanuatu, Vanuatu National Hospital

Country where clinical trial is conducted

Vanuatu, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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