Arbovirus InfectionsAEVI-FijiNCT07229677
Cohort Study of Arbovirus and Other Emerging Virus Infections in Fiji: AEVI-Fiji Cohort.
An observational study of Arbovirus Infections and Respiratory Infection Virus, run by Fiji National University at 1 site in Fiji.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arbovirus Infections, Respiratory Infection Virus
- How many people
- 910 participants
- Where
- 1 siteFiji
- Study dates
- 23 Oct 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will specifically target residents of the Central Division of Fiji, which accounts for approximately 42.7% of Fiji's total population. Most inhabitants are located within the Nausori-Lami corridor, a region characterized by a mix of urban, peri-urban, and rural areas. The Central Division is also notable for its ethnic diversity, comprising Indigenous iTaukei, Indo-Fijians, and other minority groups, making it representative of Fiji's broader demographic composition.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Fiji1 site, 1 recruiting
- Recruiting
Fiji National University
Suva, Central
Donald Wilson, MBBS, PhD-Epidemiology, +679 339 4000, donald.wilson@fnu.ac.fj
About this study
Official title: The AEVI-Fiji Cohort Study: a Longitudinal Study Assessing the Transmission Risk and Dynamics of Mosquito-borne and Respiratory Viruses in Fiji.
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 the past decades, the epidemiological landscape of arboviruses has shifted from the sequential circulation of each of the four dengue virus (DENV) serotypes to the emergence of Zika virus (ZIKV) and chikungunya virus (CHIKV), concomitantly to the concurrent circulation of multiple DENV serotypes. The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 2020 significantly challenged Fiji's healthcare system, with the Delta variant alone accounting for approximately 700 deaths, while other respiratory viruses, such as influenza A and B, cause seasonal outbreaks. Despite these threats, comprehensive and up-to-date seroprevalence data remain scarce, limiting the capacity to inform and adapt public health policies.
Methods: The cohort study of Arbovirus and other Emerging Virus Infections in Fiji (AEVI-Fiji cohort study) aims to estimate the prevalence of several arboviruses and respiratory viruses, track the evolution of individual immunity, and analyse transmission dynamics of these viruses within the Fijian population. This longitudinal study will span 38 months and will include about 900 willing participants aged six years and older, recruited from at least 210 households randomly selected across the Central Division. Four visits will be conducted 12 months apart in each household. During each visit, participants will complete a questionnaire capturing their demographic characteristics and history of infections with major arboviruses and respiratory viruses and will provide a blood sample for serological analysis. During the whole study period, participants with a suspected acute infection by an arbovirus or respiratory virus will be screened.
Discussion: For the first time in Fiji, the AEVI-Fiji cohort study will generate longitudinal data to explore the determinants of both arbovirus and respiratory virus infections. The findings are expected to guide targeted public health strategies and enhance preparedness for future infectious disease threats in Fiji and the broader Oceania region.
- Conditions
- Arbovirus Infections, Respiratory Infection Virus
- Keywords
- Seroprevalence, Longitudinal cohort, Respiratory viruses, Arboviruses, Fiji Islands
- Medical subject headings
- Arbovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the first inclusion visit (V1) at month 12
Secondary outcomes (2)
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.
Measured: 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.
Measured: From enrollment to the end of the last visit (V4) at month 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start23 Oct 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arbovirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 910 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fiji National University
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Louis Malardé, Institut Pasteur, Institut Hospitalo-Universitaire Méditerranée Infection, Ministry of Health, Fiji, London School of Hygiene and Tropical Medicine
- Responsible party
- Sponsor
- Investigators
- Donald Wilson, MBBS, PhD-Epidemiology, Principal investigator, Fiji National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229677
- Sponsor's protocol ID
- FNUHHREC 017.25
- Other IDs
- FNHRERC 08/25
- Acronym
- AEVI-Fiji
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The AEVI-Fiji Cohort Study: a Longitudinal Study Assessing the Transmission Risk and Dynamics of Mosquito-borne and Respiratory Viruses in Fiji.
- ClinicalTrials.gov ID
- NCT07229677
- Acronym / sponsor ID
- AEVI-Fiji / FNUHHREC 017.25
- Conditions
- Arbovirus Infections, Respiratory Infection Virus
- Keywords
- Seroprevalence, Longitudinal cohort, Respiratory viruses, Arboviruses, Fiji Islands
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 910 participants (estimated)
- Lead sponsor
- Fiji National UniversityUniversity, hospital or other
- Collaborators
- Institut Louis Malardé, Institut Pasteur, Institut Hospitalo-Universitaire Méditerranée Infection, Ministry of Health, Fiji, London School of Hygiene and Tropical Medicine
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 the past decades, the epidemiological landscape of arboviruses has shifted from the sequential circulation of each of the four dengue virus (DENV) serotypes to the emergence of Zika virus (ZIKV) and chikungunya virus (CHIKV), concomitantly to the concurrent circulation of multiple DENV serotypes. The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 2020 significantly challenged Fiji's healthcare system, with the Delta variant alone accounting for approximately 700 deaths, while other respiratory viruses, such as influenza A and B, cause seasonal outbreaks. Despite these threats, comprehensive and up-to-date seroprevalence data remain scarce, limiting the capacity to inform and adapt public health policies.
Methods: The cohort study of Arbovirus and other Emerging Virus Infections in Fiji (AEVI-Fiji cohort study) aims to estimate the prevalence of several arboviruses and respiratory viruses, track the evolution of individual immunity, and analyse transmission dynamics of these viruses within the Fijian population. This longitudinal study will span 38 months and will include about 900 willing participants aged six years and older, recruited from at least 210 households randomly selected across the Central Division. Four visits will be conducted 12 months apart in each household. During each visit, participants will complete a questionnaire capturing their demographic characteristics and history of infections with major arboviruses and respiratory viruses and will provide a blood sample for serological analysis. During the whole study period, participants with a suspected acute infection by an arbovirus or respiratory virus will be screened.
Discussion: For the first time in Fiji, the AEVI-Fiji cohort study will generate longitudinal data to explore the determinants of both arbovirus and respiratory virus infections. The findings are expected to guide targeted public health strategies and enhance preparedness for future infectious disease threats in Fiji and the broader Oceania region.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will specifically target residents of the Central Division of Fiji, which accounts for approximately 42.7% of Fiji's total population. Most inhabitants are located within the Nausori-Lami corridor, a region characterized by a mix of urban, peri-urban, and rural areas. The Central Division is also notable for its ethnic diversity, comprising Indigenous iTaukei, Indo-Fijians, and other minority groups, making it representative of Fiji's broader demographic composition.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: From enrollment to the end of the first inclusion visit (V1) at month 12
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.
2 secondary outcomes
Evolution of individual memory immunity for arboviruses and respiratory viruses by performing serological monitoring of the study participants over a period of 38 months
Time frame: 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
Time frame: From enrollment to the end of the last visit (V4) at month 38
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Donald Wilson, MBBS, PhD-Epidemiology principal investigator
Fiji National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arbovirus Infections and Respiratory Infection Virus, run by Fiji National University at 1 site in Fiji.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Fiji. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isireli Koroituku, Masters Infectious Diseases (+679 9090729, isireli.koroituku@fnu.ac.fj), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From enrollment to the end of the first inclusion visit (V1) at month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.