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Die klinische Studie NCT07229677 (AEVI-Fiji) für Arbovirus-Infektionen, Respiratory Infection Virus ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Cohort Study of Arbovirus and Other Emerging Virus Infections in Fiji: AEVI-Fiji Cohort. 910
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07229677 (AEVI-Fiji) ist eine beobachtungsstudie zur Untersuchung von Arbovirus-Infektionen, Respiratory Infection Virus und hat den Status offene rekrutierung. Die Studie startete am 23. Oktober 2025 und soll 910 Teilnehmer aufnehmen. Durchgeführt von Fiji National University ist der Abschluss für 31. Dezember 2028 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 1. Dezember 2025 aktualisiert.
Kurzbeschreibung
Background: Fiji, an archipelago in the South Pacific comprising 332 islands distributed among 4 health administrative divisions (Central, Western, Eastern, Northern), is particularly vulnerable to the (re-)emergence of arboviruses and respiratory viruses due to its sub-tropical climate, the presence of several mosquito vector species, and connections with many countries in the Pacific, Asia and North America. Over t...Mehr anzeigen
Offizieller Titel
The AEVI-Fiji Cohort Study: a Longitudinal Study Assessing the Transmission Risk and Dynamics of Mosquito-borne and Respiratory Viruses in Fiji.
Erkrankungen
Arbovirus-InfektionenRespiratory Infection VirusWeitere Studien-IDs
- AEVI-Fiji
- FNUHHREC 017.25
- FNHRERC 08/25 (Andere Kennung) (Fiji National Health Research Ethics Review Committee)
NCT-Nummer
Studienbeginn (tatsächlich)
2025-10-23
Zuletzt aktualisiert
2025-12-01
Studienende (vorauss.)
2028-12-31
Geplante Rekrutierung
910
Studientyp
Beobachtungsstudie
Status
Offene Rekrutierung
Stichwörter
Seroprevalence
Longitudinal cohort
Respiratory viruses
Arboviruses
Fiji Islands
Longitudinal cohort
Respiratory viruses
Arboviruses
Fiji Islands
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Households members representative of the Fijian population (6 years and older) The study sample comprises randomly selected households from 30 Enumeration Areas (EAs) within the Central Division, selected in proportion to population size to ensure representativeness of the Fijian population. Both urban and rural settings are included. All individuals aged 6 years and above residing for more than 6 months in the selected households are invited to participate in the study. | Nicht zutreffend |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Level of herd immunity for arboviruses and respiratory viruses by conducting a seroprevalence survey among households including both children and adults In Central division of Fiji | Proportion of participants with Immunoglobulin type G (IgG) antibodies, detected in blood samples : IgG antibodies specific to a panel of arboviruses (including the four DENV serotypes, ZIKV, CHIKV, Ross River virus \[RRV\], yellow fever virus \[YFV\], Japanese encephalitis virus \[JEV\], West Nile virus \[WNV\]) and respiratory viruses (including influenza viruses A and B, SARS-CoV-2), as well as any major emerging pathogen (pathogen X) will be detected, using a multiplex microsphere immunoassay (MIA). Additionally, seroneutralisation tests will be performed to detect and quantify neutralising antibodies against the same panel of viruses.
The IgG and neutralising antibody results for each virus will be combined to determine overall immune response (positive/negative) for the targeted viruses. | From enrollment to the end of the first inclusion visit (V1) at month 12 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Evolution of individual memory immunity for arboviruses and respiratory viruses by performing serological monitoring of the study participants over a period of 38 months | Proportion of participants with Immunoglobulin type G (IgG) antibodies, detected in blood samples : IgG antibodies specific to a panel of arboviruses (including each of the four DENV serotypes, ZIKV, CHIKV, RRV, YFV, JEV, WNV) and respiratory viruses (including influenza viruses A and B, SARS-CoV-2), as well as any major emerging pathogen (pathogen X) will be detected, using a MIA to track changes in antibody composition (seroconversion or seroreversion) and levels (increase, decrease, or stability), as well as possible cross-reaction phenomena. Additionally, seroneutralisation tests will be performed to detect and quantify neutralising antibodies against the same panel of viruses.
The IgG and neutralising antibody results for each virus will be combined to determine overall immune response (positive/negative) for the targeted viruses. | From enrollment to the end of the last visit (V4) at month 38 |
Systematic screening and sequencing of acute infections of the study participants over a period of 38 months | Systematic screening of acute infections for participants to a panel of arboviruses (including each of the four DENV serotypes, ZIKV, CHIKV, RRV, YFV, JEV, WNV) and respiratory viruses (including influenza viruses A and B, SARS-CoV-2), as well as any major emerging pathogen (pathogen X). Positive samples will undergo whole-genome sequencing.
This screening and sequencing will allow identification of the viral strain responsible for each infection. | From enrollment to the end of the last visit (V4) at month 38 |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Mindestalter
6 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
- Individuals aged 6 years and older who reside in the Central Division of Fiji
- Have lived in the selected household for at least six months at the time of enrollment
- Pregnant women;
- Women in labor, or breastfeeding mothers;
- Individuals deprived of liberty by judicial or administrative decision;
- Individuals under psychiatric care or admitted to a health or social care facility for purposes other than participation in the study;
- Adults under legal protection or unable to provide informed consent;
- Homeless individuals;
- Individuals with severe disabilities preventing mobility;
- Individuals unable to understand or complete the study questionnaire
- 🏛️Institut ...
Zentrale Studienkontakte
Kontakt: Isireli Koroituku, Masters Infectious Diseases, +679 9090729, [email protected]
Kontakt: Ahmed Abdouni, PhD, MPH, +689 89527294, [email protected]
1 Studienstandorte in 1 Ländern
Central
Fiji National University, Suva, Central, Fiji
Donald Wilson, MBBS, PhD-Epidemiology, Kontakt, +679 339 4000, [email protected]
Offene Rekrutierung