NCT04434846

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....

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

February 8, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2021

Completed
3 years until next milestone

Results Posted

Study results publicly available

April 26, 2024

Completed
Last Updated

April 26, 2024

Status Verified

May 7, 2021

Enrollment Period

3 months

First QC Date

June 16, 2020

Results QC Date

January 27, 2022

Last Update Submit

March 27, 2024

Conditions

Keywords

Vector-Borne DiseasesArbovirusSerological SurveySeroprevalenceSoutheast AsiaNatural History

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Comparative Assessment of Seroprevalence Via PRNT50 Titers for ZIKV, DENV, and CHIKV in Cambodian Adults to That of Thai Adults.

    Day 0

  • Assessment of Reactivity to Salivary Gland Homogenate of Aedes Aegypti as Detected by ELISA or Western Blot in Human Sera.

    Day 0

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • \. 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Malaria Center

Phnom Penh, Cambodia

Location

Related Publications (3)

  • 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.

    PMID: 23563266BACKGROUND
  • 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.

    PMID: 30826189BACKGROUND
  • 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.

    PMID: 25806915BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sera from macaques and humans

MeSH Terms

Conditions

DengueZika Virus InfectionVector Borne DiseasesChikungunya Fever

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, ViralAlphavirus InfectionsTogaviridae Infections

Results Point of Contact

Title
Jessica Manning
Organization
NIH

Study Officials

  • Christina Yek, M.D.

    National Institute of Allergy and Infectious Diseases (NIAID)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 17, 2020

Study Start

February 8, 2021

Primary Completion

May 7, 2021

Study Completion

May 7, 2021

Last Updated

April 26, 2024

Results First Posted

April 26, 2024

Record last verified: 2021-05-07

Locations