Clinical trial NCT04434846: Sylvatic Transmission of Zika, Dengue, and Chikungunya Viruses in Thailand and Cambodia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dengue Fever
Zika
Vector-Borne Diseases
Chikungunya
Keywords: Vector-Borne Diseases
Arbovirus
Serological Survey
Seroprevalence
Southeast Asia
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2020-06-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: * INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated ICF
2. Able to provide informed consent
3. Stated willingness to comply with study procedures
4. Male or female, aged 18-55 years
5. Live/work within approximately 10 km of the Wat Amphae Phnom monkey habitat for minimum of 2 years
6. In good general health as evidenced by screening medical history
7. Willing to allow biological samples to be stored for future research

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)

Primary outcomes:
measure: Assessment of DENV, ZIKV, CHIKV Seroprevalence Via Screening PRNT50 Titers in Cambodian Adults.
timeFrame: 300 at day 0
Secondary outcomes:
measure: Comparative Assessment of Seroprevalence Via PRNT50 Titers for ZIKV, DENV, and CHIKV in Cambodian Adults to That of Thai Adults.
timeFrame: Day 0
measure: Assessment of Reactivity to Salivary Gland Homogenate of Aedes Aegypti as Detected by ELISA or Western Blot in Human Sera.
timeFrame: Day 0
Other outcomes:
Locations:
city: Phnom Penh
country: Cambodia
facility: National Malaria Center
Study officials:
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
name: Christina Yek, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.