Dengue FeverNCT04434846
Sylvatic Transmission of Zika, Dengue, and Chikungunya Viruses in Thailand and Cambodia
An observational study of Dengue Fever and Zika, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Cambodia.
Trial summary
Background: Zika, dengue, and chikungunya are spread by mosquitos. These diseases have a major impact on public health. This is especially true in in Southeast Asia. Non-human primates (such as macaques) could play an essential role in spreading these diseases. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Dengue Fever, Zika, Vector-Borne Diseases
- How many people
- 300 participants
- Where
- 1 siteCambodia
- Study dates
- 8 Feb 2021to 7 May 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Healthy male or female volunteers from Chbar Mon, Cambodia who live or work within approximately 10 km of long-tailed macaque habitats for a minimum of 2 years.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated ICF
- Able to provide informed consent
- Stated willingness to comply with study procedures
- Male or female, aged 18-55 years
- Live/work within approximately 10 km of the Wat Amphae Phnom monkey habitat for minimum of 2 years
- In good general health as evidenced by screening medical history
- Willing to allow biological samples to be stored for future research
Who cannot join
- 1. Any underlying, chronic, or current medical condition that, in the opinion of the investigator, would interfere with participation in the study (e.g., inability or great difficulty in drawing blood)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Sylvatic Transmission and Reservoir Potential of Zika, Dengue, and Chikungunya Viruses of Co-located Humans and Long-tailed Macaques of Thailand and Cambodia
Background:
Zika, dengue, and chikungunya are spread by mosquitos. These diseases have a major impact on public health. This is especially true in in Southeast Asia. Non-human primates (such as macaques) could play an essential role in spreading these diseases. Researchers want to further understand the relationship between humans and these primates. They want to see how this affects how mosquito-borne viruses are spread in Southeast Asia.
Read more
Objective:
To describe the prevalence of Zika virus, dengue virus, and chikungunya virus in the blood of people who live close to long-tailed macaques in Thailand and Cambodia.
Eligibility:
Healthy people aged 18-55 who have lived or worked within approximately 10 kilometers of the Wat Amphae Phnom monkey habitat in Kampong Speu, Cambodia, for a minimum of 2 years
Design:
Participation will last 1 day.
Participants will be screened in person through an interview. Their medical history will be reviewed.
Participants will give information about themselves. This will include sex, age, and behaviors related to the spread of mosquito-borne disease. For example, they will be asked about the number of water containers at their home. They will be asked about recent travel. They will be asked about the extent of their contact with the macaques.
Participants will give a blood sample....
Read the detailed description
Arboviral epidemics continue to emerge suddenly and spread of disease is unpredictable. The 2015-16 Zika epidemic resulted in a high case number in Thailand, but not in neighboring Cambodia. It is known that nonhuman primates (NHPs) are important reservoirs of arboviruses, but the importance of their epidemiological role in the transmission of arboviruses is not clearly understood. While transmission dynamics are complex and require consideration of many variables, primate reservoirs are not routinely sampled, particularly in Southeast Asia, because of the level of operational complexity and skill required.
Here, we propose a serological survey for evidence of Zika virus (ZIKV), dengue virus (DENV), and chikungunya virus (CHIKV) exposure in long-tailed macaques and human adults who live or work in close proximity to these monkeys in Thailand and Cambodia. We hypothesize that ZIKV seroprevalence in both humans and macaques will be higher in Thailand than Cambodia. With the current rise of arboviral diseases around the world, we hope the results of this study contribute to better understanding of the epidemiology and burden of arboviral diseases in this region.
- Conditions
- Dengue Fever, Zika, Vector-Borne Diseases, Chikungunya
- Keywords
- Vector-Borne Diseases, Arbovirus, Serological Survey, Seroprevalence, Southeast Asia, Natural History
- Medical subject headings
- Dengue, Zika Virus Infection, Vector Borne Diseases, Chikungunya Fever
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 |
|---|---|---|
| 1 | Healthy Cambodian Adults aged 18-55 were screened for antibodies to ZIKV, DENV, and CHIKV at a single time point at Amphae Phnom, Chbar Mon, Cambodia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of DENV, ZIKV, CHIKV Seroprevalence Via Screening PRNT50 Titers in Cambodian Adults.
Proportion of Participants with DENV, ZIKV, CHIKV Seroprevalence Via Screening PRNT50. Outcome will be analyzed unadjusted and adjusted for age, location, vector exposure, and sylvatic reservoir exposure.
Measured: 300 at day 0
Secondary outcomes (2)
Comparative Assessment of Seroprevalence Via PRNT50 Titers for ZIKV, DENV, and CHIKV in Cambodian Adults to That of Thai Adults.
Understanding how the prevalence of these Aedes transmitted viruses differs across the Mekong region is critical for cross-border disease detection and management, particularly given the high level of human migration in the Greater Mekong Subregion.
Measured: Day 0
Assessment of Reactivity to Salivary Gland Homogenate of Aedes Aegypti as Detected by ELISA or Western Blot in Human Sera.
Characterizing vector salivary protein reactivity profiles (mosquitos, ticks, fleas) in Cambodians with vector- borne disease is the first step to better understanding transmission patterns, responsible vectors, and Cambodians' risk of exposure to these vectors.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start8 Feb 2021
- Primary completion7 May 2021
- Study completion7 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Christina Yek, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434846
- Sponsor's protocol ID
- 999920054
- Other IDs
- 20-I-N054
- Status last verified
- 7 May 2021
- First submitted
- 16 Jun 2020
- Last updated
- 26 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Bhatt S, Gething PW, Brady OJ, Messina JP, Farlow AW, Moyes CL, Drake JM, Brownstein JS, Hoen AG, Sankoh O, Myers MF, George DB, Jaenisch T, Wint GR, Simmons CP, Scott TW, Farrar JJ, Hay SI. The global distribution and burden of dengue. Nature. 2013 Apr 25;496(7446):504-7. doi: 10.1038/nature12060. Epub 2013 Apr 7.
PubMed 23563266Ruchusatsawat K, Wongjaroen P, Posanacharoen A, Rodriguez-Barraquer I, Sangkitporn S, Cummings DAT, Salje H. Long-term circulation of Zika virus in Thailand: an observational study. Lancet Infect Dis. 2019 Apr;19(4):439-446. doi: 10.1016/S1473-3099(18)30718-7. Epub 2019 Feb 27.
PubMed 30826189Weaver SC, Lecuit M. Chikungunya virus and the global spread of a mosquito-borne disease. N Engl J Med. 2015 Mar 26;372(13):1231-9. doi: 10.1056/NEJMra1406035. No abstract available.
PubMed 25806915
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Sylvatic Transmission and Reservoir Potential of Zika, Dengue, and Chikungunya Viruses of Co-located Humans and Long-tailed Macaques of Thailand and Cambodia
- ClinicalTrials.gov ID
- NCT04434846
- Acronym / sponsor ID
- 999920054
- Conditions
- Dengue Fever, Zika, Vector-Borne Diseases, Chikungunya
- Keywords
- Vector-Borne Diseases, Arbovirus, Serological Survey, Seroprevalence, Southeast Asia, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 7 May 2021 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Posted 26 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Zika, dengue, and chikungunya are spread by mosquitos. These diseases have a major impact on public health. This is especially true in in Southeast Asia. Non-human primates (such as macaques) could play an essential role in spreading these diseases. Researchers want to further understand the relationship between humans and these primates. They want to see how this affects how mosquito-borne viruses are spread in Southeast Asia.
Objective:
To describe the prevalence of Zika virus, dengue virus, and chikungunya virus in the blood of people who live close to long-tailed macaques in Thailand and Cambodia.
Eligibility:
Healthy people aged 18-55 who have lived or worked within approximately 10 kilometers of the Wat Amphae Phnom monkey habitat in Kampong Speu, Cambodia, for a minimum of 2 years
Design:
Participation will last 1 day.
Participants will be screened in person through an interview. Their medical history will be reviewed.
Participants will give information about themselves. This will include sex, age, and behaviors related to the spread of mosquito-borne disease. For example, they will be asked about the number of water containers at their home. They will be asked about recent travel. They will be asked about the extent of their contact with the macaques.
Participants will give a blood sample....
Detailed description
Arboviral epidemics continue to emerge suddenly and spread of disease is unpredictable. The 2015-16 Zika epidemic resulted in a high case number in Thailand, but not in neighboring Cambodia. It is known that nonhuman primates (NHPs) are important reservoirs of arboviruses, but the importance of their epidemiological role in the transmission of arboviruses is not clearly understood. While transmission dynamics are complex and require consideration of many variables, primate reservoirs are not routinely sampled, particularly in Southeast Asia, because of the level of operational complexity and skill required.
Here, we propose a serological survey for evidence of Zika virus (ZIKV), dengue virus (DENV), and chikungunya virus (CHIKV) exposure in long-tailed macaques and human adults who live or work in close proximity to these monkeys in Thailand and Cambodia. We hypothesize that ZIKV seroprevalence in both humans and macaques will be higher in Thailand than Cambodia. With the current rise of arboviral diseases around the world, we hope the results of this study contribute to better understanding of the epidemiology and burden of arboviral diseases in this region.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Healthy Cambodian Adults aged 18-55 were screened for antibodies to ZIKV, DENV, and CHIKV at a single time point at Amphae Phnom, Chbar Mon, Cambodia. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Healthy male or female volunteers from Chbar Mon, Cambodia who live or work within approximately 10 km of long-tailed macaque habitats for a minimum of 2 years.
Key inclusion criteria (8 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated ICF
- Able to provide informed consent
- Stated willingness to comply with study procedures
- Male or female, aged 18-55 years
Key exclusion criteria (1 listed)
- 1. Any underlying, chronic, or current medical condition that, in the opinion of the investigator, would interfere with participation in the study (e.g., inability or great difficulty in drawing blood)
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
Assessment of DENV, ZIKV, CHIKV Seroprevalence Via Screening PRNT50 Titers in Cambodian Adults.
Time frame: 300 at day 0
Proportion of Participants with DENV, ZIKV, CHIKV Seroprevalence Via Screening PRNT50. Outcome will be analyzed unadjusted and adjusted for age, location, vector exposure, and sylvatic reservoir exposure.
2 secondary outcomes
Comparative Assessment of Seroprevalence Via PRNT50 Titers for ZIKV, DENV, and CHIKV in Cambodian Adults to That of Thai Adults.
Time frame: Day 0
Assessment of Reactivity to Salivary Gland Homogenate of Aedes Aegypti as Detected by ELISA or Western Blot in Human Sera.
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23563266Bhatt S, Gething PW, Brady OJ, Messina JP, Farlow AW, Moyes CL, Drake JM, Brownstein JS, Hoen AG, Sankoh O, Myers MF, George DB, Jaenisch T, Wint GR, Simmons CP, Scott TW, Farrar JJ, Hay SI. The global distribution and burden of dengue. Nature. 2013 Apr 25;496(7446):504-7. doi: 10.1038/nature12060. Epub 2013 Apr 7.
- Background: PubMed 30826189Ruchusatsawat K, Wongjaroen P, Posanacharoen A, Rodriguez-Barraquer I, Sangkitporn S, Cummings DAT, Salje H. Long-term circulation of Zika virus in Thailand: an observational study. Lancet Infect Dis. 2019 Apr;19(4):439-446. doi: 10.1016/S1473-3099(18)30718-7. Epub 2019 Feb 27.
- Background: PubMed 25806915Weaver SC, Lecuit M. Chikungunya virus and the global spread of a mosquito-borne disease. N Engl J Med. 2015 Mar 26;372(13):1231-9. doi: 10.1056/NEJMra1406035. No abstract available.
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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. This study is not recruiting at the moment.
Christina Yek, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
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 Dengue Fever and Zika, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Cambodia.
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 8 inclusion and 1 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: finished, as of the sponsor's last update on 26 Apr 2024. 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 Cambodia. 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?
Yes. Results are posted in the registry (first posted 26 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of DENV, ZIKV, CHIKV Seroprevalence Via Screening PRNT50 Titers in Cambodian Adults. (time frame: 300 at day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04434846, which also lists 3 linked publications.
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 26 Apr 2024.