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Trial Outcomes & Findings for Characterization of Skin Immunity to Aedes Aegypti Saliva in Dengue-endemic Participants in Cambodia (NCT NCT04350905)

NCT ID: NCT04350905

Last Updated: 2022-04-12

Results Overview

Measurement of changes in the early and late innate immune response and cellular recruitment in bitten skin versus unbitten skin by: a) immunohistochemistry of target proteins at Day 0 timepoints b) immunophenotyping of innate immune cell subsets in dissociated skin sample at Day 0 timepoints c) determination of cytokine profile in dissociated skin sample supernatant at Day 0 timepoints d) differential cDNA expression prepared from skin RNA and analyzed via RNASeq at Day 0 timepoints

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

42 participants

Primary outcome timeframe

Day 0 timepoints

Results posted on

2022-04-12

Participant Flow

Participant milestones

Participant milestones
Measure
Mosquito Feeding
Each participant will receive one mosquito feeding with 5 starved female Aedes aegypti mosquitoes. Mosquito Feeding: Mosquito feedings will be conducted with Aedes aegypti colonies raised at the CNM (National Malaria Center) Malaria and Vector Research Laboratory (MVRL), an established state of the art insectaries for mosquitoes was built in 2014 to ACL2 (arthropodcontainment level 2)-level specifications.
Overall Study
STARTED
42
Overall Study
COMPLETED
41
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Characterization of Skin Immunity to Aedes Aegypti Saliva in Dengue-endemic Participants in Cambodia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Mosquito Feeding
n=42 Participants
Each participant will receive one mosquito feeding with 5 starved female Aedes aegypti mosquitoes. Mosquito Feeding: Mosquito feedings will be conducted with Aedes aegypti colonies raised at the CNM (National Malaria Center) Malaria and Vector Research Laboratory (MVRL), an established state of the art insectaries for mosquitoes was built in 2014 to ACL2 (arthropodcontainment level 2)-level specifications.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
42 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
13 Participants
n=5 Participants
Sex: Female, Male
Male
29 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
42 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
Cambodia
42 participants
n=5 Participants
Exposure to Dengue
42 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Day 0 timepoints

Population: Flow and RNAseq populations

Measurement of changes in the early and late innate immune response and cellular recruitment in bitten skin versus unbitten skin by: a) immunohistochemistry of target proteins at Day 0 timepoints b) immunophenotyping of innate immune cell subsets in dissociated skin sample at Day 0 timepoints c) determination of cytokine profile in dissociated skin sample supernatant at Day 0 timepoints d) differential cDNA expression prepared from skin RNA and analyzed via RNASeq at Day 0 timepoints

Outcome measures

Outcome measures
Measure
Mosquito Feeding
n=30 Participants
Each participant will receive one mosquito feeding with 5 starved female Aedes aegypti mosquitoes. Mosquito Feeding: Mosquito feedings will be conducted with Aedes aegypti colonies raised at the CNM (National Malaria Center) Malaria and Vector Research Laboratory (MVRL), an established state of the art insectaries for mosquitoes was built in 2014 to ACL2 (arthropodcontainment level 2)-level specifications.
Measurement of Change in Early and Late Innate Immune Responses Using Gene Expression and Flow Cytometry in Participants' Skin
% total DCs at 30 min
50 % of total dendritic cells
Interval 45.0 to 55.0
Measurement of Change in Early and Late Innate Immune Responses Using Gene Expression and Flow Cytometry in Participants' Skin
% activated dermal DCs at 30 min
5 % of total dendritic cells
Interval 3.0 to 8.0

PRIMARY outcome

Timeframe: Day 2 (48 hr post feeding)

Measurement of changes in the adaptive immune response and cellular recruitment in bitten skin versus unbitten skin by: a) immunohistochemistry of target proteins at Day 2 timepoints b) phenotyping of adaptive immune cell subsets in dissociated skin sample at Day 2 timepoints c) determination of cytokine profile in dissociated skin sample supernatant at Day 2 timepoints d) differential cDNA expression prepared from skin RNA and analyzed via RNASeq at Day 2 timepoints

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Describing and understanding cellular immunity to Aedes saliva in heavily exposed individuals will simulate endemic conditions and will inform vaccine design in these target populations.

Outcome measures

Outcome data not reported

Adverse Events

Mosquito Feeding

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