Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT05153018
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2021-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Population Immunity AgaiNst mosquitO-borne Diseases in Vanuatu
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071243', 'term': 'Zika Virus Infection'}, {'id': 'D003715', 'term': 'Dengue'}, {'id': 'D000096745', 'term': 'Ross River Virus Infection'}, {'id': 'D065632', 'term': 'Chikungunya Fever'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006482', 'term': 'Hemorrhagic Fevers, Viral'}, {'id': 'D018354', 'term': 'Alphavirus Infections'}, {'id': 'D014036', 'term': 'Togaviridae Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2021-11-29', 'studyFirstSubmitQcDate': '2021-11-29', 'lastUpdatePostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of the seroprevalence of dengue, Zika, chikungunya, Ross River and Covid-19 in Vanuatu.', 'timeFrame': '1 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Serology', 'Epidemiology', 'Vanuatu'], 'conditions': ['Arbovirus Disease', 'Zika', 'Dengue', 'Ross River', 'Chikungunya', 'COVID-19']}, 'descriptionModule': {'briefSummary': '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.\n\nNumerous 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.\n\nCOVID-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.\n\nLocal 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.', 'detailedDescription': 'The PIANO project is a non-comparative observational prospective cross-sectional descriptive survey on a representative random sample of the population.\n\nThe 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.\n\nThe main objective of the current project is to determine the seroprevalence of dengue, Zika, chikungunya, Ross River and COVID-19 in Vanuatu.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals informed of the research and having given their written consent to participate in the study\n* Individuals aged 6 years old or more\n* Individuals living in Vanuatu for more than 6 months\n* Individuals informed of the research, its objectives and procedure\n\nExclusion Criteria:\n\n* Tourists and people present in Vanuatu for less than 6 months\n* Persons intellectually disabled or under guardianship\n* Persons suffering from a febrile syndrome\n* Missing information related to age or hometown\n* Children weighting less than 18 kg'}, 'identificationModule': {'nctId': 'NCT05153018', 'acronym': 'PIANO', 'briefTitle': 'Population Immunity AgaiNst mosquitO-borne Diseases in Vanuatu', 'organization': {'class': 'INDUSTRY', 'fullName': 'Institut Pasteur'}, 'officialTitle': 'Population Immunity AgaiNst mosquitO-borne Diseases in Vanuatu', 'orgStudyIdInfo': {'id': '2020-100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A representative random sample of the population', 'description': '1,200 non-febrile individuals aged older than 6 years old', 'interventionNames': ['Other: Blood collection']}], 'interventions': [{'name': 'Blood collection', 'type': 'OTHER', 'description': 'a 4-mL blood sample collected in a dry tube', 'armGroupLabels': ['A representative random sample of the population']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Luganville', 'country': 'Vanuatu', 'facility': 'Blood centers, hospitals, health facilities', 'geoPoint': {'lat': -15.51989, 'lon': 167.16235}}, {'city': 'Luganville', 'country': 'Vanuatu', 'facility': 'Schools', 'geoPoint': {'lat': -15.51989, 'lon': 167.16235}}, {'city': 'Port Vila', 'country': 'Vanuatu', 'facility': 'Blood centers, hospitals, health facilities', 'geoPoint': {'lat': -17.73648, 'lon': 168.31366}}, {'city': 'Port Vila', 'country': 'Vanuatu', 'facility': 'Schools', 'geoPoint': {'lat': -17.73648, 'lon': 168.31366}}], 'overallOfficials': [{'name': 'Myrielle Dupont-Rouzeyrol, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut Pasteur de Nouvelle-Calédonie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Pasteur', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ministry of Health of Vanuatu', 'class': 'UNKNOWN'}, {'name': 'Vanuatu National Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}