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| ID | Type | Description | Link |
|---|---|---|---|
| 20-I-N054 |
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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....
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 300 at day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 |
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In order to be eligible to participate in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA:
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)
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Christina Yek, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Malaria Center | Phnom Penh | Cambodia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23563266 | Background | 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. | |
| 30826189 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cambodian Adults in Observational Cross-Sectional Study of Arboviral Exposure | Healthy Cambodian Adults of ages 18-55 screening for exposure to ZIKV, DENV, and/or CHIKV. To clarify, no THAI adults were enrolled under this protocol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cross Sectional Enrollment of 300 Adults | Adults of ages 18-55 with ZIKV, DENV, and/or CHIKV seroprevalence living near Amphae Phnom, Cambodia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 300 at day 0 |
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This was a cross sectional bioprocurement protocol with a one-time blood draw. Adverse events were monitored on that day, participants exited the study the same day but were always able to call study team - up to three months after study exit - should an adverse event have occurred from a low-risk procedure such as phlebotomy. The enrollment and monitoring period was during the month of February 2020.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 300 Adults Ages 18-55 With ZIKV, DENV, and/or CHIKV Seroprevalence. | Adults ages 18-55 with ZIKV, DENV, and/or CHIKV seroprevalence. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Manning | NIH | +85561856557 | Jessica.manning@nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 12, 2020 | Jan 27, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003715 | Dengue |
| D000071243 | Zika Virus Infection |
| D000079426 | Vector Borne Diseases |
| D065632 | Chikungunya Fever |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
| D014777 | Virus Diseases |
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Sera from macaques and humans
| 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. | Day 0 |
| Ruchusatsawat 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. |
| 25806915 | Background | Weaver 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. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Posted | Count of Participants | Participants | Day 0 |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Day 0 |
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| 0 |
| 300 |
| 0 |
| 300 |
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| 300 |
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| D018177 |
| Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
| D018354 | Alphavirus Infections |
| D014036 | Togaviridae Infections |