Trial Outcomes & Findings for Sylvatic Transmission of Zika, Dengue, and Chikungunya Viruses in Thailand and Cambodia (NCT NCT04434846)

NCT ID: NCT04434846

Last Updated: 2024-04-26

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

300 participants

Primary outcome timeframe

300 at day 0

Results posted on

2024-04-26

Participant Flow

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
300
Overall Study
COMPLETED
300
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sylvatic Transmission of Zika, Dengue, and Chikungunya Viruses in Thailand and Cambodia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cross Sectional Enrollment of 300 Adults
n=300 Participants
Adults of ages 18-55 with ZIKV, DENV, and/or CHIKV seroprevalence living near Amphae Phnom, Cambodia
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
300 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
44 years
STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male
Female
173 Participants
n=5 Participants
Sex: Female, Male
Male
127 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
300 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
Cambodia
300 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Cross Sectional Enrollment of 300 Adults
n=300 Participants
Adults of ages 18-55 with ZIKV antibodies living near Amphae Phnom, Cambodia
Assessment of DENV, ZIKV, CHIKV Seroprevalence Via Screening PRNT50 Titers in Cambodian Adults.
300 Participants

SECONDARY outcome

Timeframe: Day 0

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.

Outcome measures

Outcome measures
Measure
Cross Sectional Enrollment of 300 Adults
n=300 Participants
Adults of ages 18-55 with ZIKV antibodies living near Amphae Phnom, Cambodia
Comparative Assessment of Seroprevalence Via PRNT50 Titers for ZIKV, DENV, and CHIKV in Cambodian Adults to That of Thai Adults.
300 Participants

SECONDARY outcome

Timeframe: Day 0

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.

Outcome measures

Outcome measures
Measure
Cross Sectional Enrollment of 300 Adults
n=300 Participants
Adults of ages 18-55 with ZIKV antibodies living near Amphae Phnom, Cambodia
Assessment of Reactivity to Salivary Gland Homogenate of Aedes Aegypti as Detected by ELISA or Western Blot in Human Sera.
300 Participants

Adverse Events

300 Adults Ages 18-55 With ZIKV, DENV, and/or CHIKV Seroprevalence.

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jessica Manning

NIH

Phone: +85561856557

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place