Trial Outcomes & Findings for Development of Human Nasal Challenge Models With Microbial Constituents and Grass Pollen (NCT NCT02090374)
NCT ID: NCT02090374
Last Updated: 2021-11-05
Results Overview
The primary outcome measure is IFN-y in nasal mucosal lining fluid after nasal challenge
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
93 participants
Primary outcome timeframe
0, 1, 2, 3, 4, 6, 8 hours post-dose
Results posted on
2021-11-05
Participant Flow
Participant milestones
| Measure |
Poly ICLC Dose Escalation
Poly ICLC nasal challenge dose esalation: 10ug, 100ug, 500ug within same volunteers
|
Poly ICLC Highest Dose
Poly ICLC nasal challenge single dose of 1000ug
|
Poly I:C Single Dose
Poly I:C nasal challenge single dose 500ug
|
R848 High Dose
R848 nasal challenge with high dose 10ug
|
R848 Low Dose
R848 nasal challenge low dose 1-2ug (0.02ug/kg)
|
Grass Pollen
Timothy Grass Pollen nasal challenge: Dose: 5000 SQ-U/100µl
|
Vitamin D Supplementation
Vitamin D 4000U oraly daily
|
Tuberculin
Tuberculin PPD nasal challenge
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
4
|
4
|
9
|
35
|
15
|
16
|
2
|
|
Overall Study
COMPLETED
|
8
|
4
|
4
|
9
|
35
|
15
|
16
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Poly ICLC Dose Escalation
n=8 Participants
Dose esalation within same volunteers: 10ug, 100ug, 500ug
|
Poly ICLC Highest Dose
n=4 Participants
Single dose: 1000ug
|
Poly I:C Single Dose
n=4 Participants
Poly I:C nasal challenge single dose: 500ug
|
R848 High Dose
n=9 Participants
R848 nasal challenge high dose: 10ug
|
R848 Low Dose
n=35 Participants
R848 nasal challenge low dose: 1-2ug (0.02ug/kg)
|
Grass Pollen
n=15 Participants
Timothy Grass Pollen nasal challenge: 5000 SQ-U/100µl
|
Vitamin D Supplementation
n=16 Participants
Vitamin D 4000U oraly daily
|
Tuberculin
n=2 Participants
Tuberculin PPD nasal challenge
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=8 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=9 Participants
|
35 Participants
n=35 Participants
|
15 Participants
n=15 Participants
|
16 Participants
n=16 Participants
|
2 Participants
n=2 Participants
|
93 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=8 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=9 Participants
|
20 Participants
n=35 Participants
|
7 Participants
n=15 Participants
|
8 Participants
n=16 Participants
|
1 Participants
n=2 Participants
|
54 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=8 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
15 Participants
n=35 Participants
|
8 Participants
n=15 Participants
|
8 Participants
n=16 Participants
|
1 Participants
n=2 Participants
|
39 Participants
n=93 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8 hours post-doseThe primary outcome measure is IFN-y in nasal mucosal lining fluid after nasal challenge
Outcome measures
| Measure |
Poly ICLC Dose Escalation
n=8 Participants
Poly ICLC nasal challenge dose escalation: 10ug, 100ug, 500ug
|
Poly ICLC High Dose
n=4 Participants
Poly ICLC nasal challenge single dose of 1000ug
|
Poly I:C Single Dose
n=4 Participants
Poly I:C nasal challenge 500ug
|
R848 High Dose
n=9 Participants
R848 nasal challenge with high dose 10ug
|
R848 Low Dose
n=35 Participants
R848 nasal challenge low dose 1-2ug (0.02ug/kg)
|
Grass Pollen
n=15 Participants
Timothy Grass Pollen: Dose: 5000 SQ-U/100µl
|
Vitamin D Supplementation
n=16 Participants
Vitamin D 4000U oraly daily
|
Tuberculin
n=2 Participants
Tuberculin PPD nasal challenge
|
|---|---|---|---|---|---|---|---|---|
|
IFN-y Protein Response in Mucosal Lining Fluid
|
NA pg/hr/ml
Below the level of detection
|
3.29 pg/hr/ml
Interval 1.84 to 4.74
|
9.42 pg/hr/ml
Interval 4.76 to 14.08
|
8.20 pg/hr/ml
Interval 6.3 to 10.11
|
5.10 pg/hr/ml
Interval 3.88 to 6.32
|
NA pg/hr/ml
Below the level of detection
|
NA pg/hr/ml
Below the level of detection
|
NA pg/hr/ml
Insufficient number of participants. Samples were therefore not assessed for cytokine measurements.
|
Adverse Events
Poly ICLC Dose Escalation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Poly ICLC Higest Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Poly I:C Single Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
R848 High Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
R848 Low Dose
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Grass Pollen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vitamin D Supplementation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tuberculin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Poly ICLC Dose Escalation
n=8 participants at risk
Poly ICLC nasal challenge dose escalation: 10ug, 100ug, 500ug
|
Poly ICLC Higest Dose
n=4 participants at risk
Poly ICLC nasal challenge 1000ug
|
Poly I:C Single Dose
n=4 participants at risk
Poly I:C nasal challenge single dose 500ug
|
R848 High Dose
n=9 participants at risk
R848 high dose 10ug
|
R848 Low Dose
n=35 participants at risk
R848 low dose 1-2ug 0.02ug/kg
|
Grass Pollen
n=15 participants at risk
Timothy Grass Pollen: Dose: 5000 SQ-U/100µl
|
Vitamin D Supplementation
n=16 participants at risk
Vitamin D 4000U oraly daily
|
Tuberculin
n=2 participants at risk
Tuberculin PPD nasal challenge
|
|---|---|---|---|---|---|---|---|---|
|
Immune system disorders
Fever
|
0.00%
0/8 • 24 hours
|
0.00%
0/4 • 24 hours
|
0.00%
0/4 • 24 hours
|
33.3%
3/9 • Number of events 3 • 24 hours
|
0.00%
0/35 • 24 hours
|
0.00%
0/15 • 24 hours
|
0.00%
0/16 • 24 hours
|
0.00%
0/2 • 24 hours
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • 24 hours
|
0.00%
0/4 • 24 hours
|
0.00%
0/4 • 24 hours
|
33.3%
3/9 • Number of events 3 • 24 hours
|
8.6%
3/35 • 24 hours
|
0.00%
0/15 • 24 hours
|
0.00%
0/16 • 24 hours
|
0.00%
0/2 • 24 hours
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • 24 hours
|
0.00%
0/4 • 24 hours
|
0.00%
0/4 • 24 hours
|
33.3%
3/9 • Number of events 3 • 24 hours
|
2.9%
1/35 • 24 hours
|
0.00%
0/15 • 24 hours
|
0.00%
0/16 • 24 hours
|
0.00%
0/2 • 24 hours
|
|
Musculoskeletal and connective tissue disorders
Fatigue
|
0.00%
0/8 • 24 hours
|
0.00%
0/4 • 24 hours
|
0.00%
0/4 • 24 hours
|
33.3%
3/9 • Number of events 3 • 24 hours
|
17.1%
6/35 • 24 hours
|
0.00%
0/15 • 24 hours
|
0.00%
0/16 • 24 hours
|
0.00%
0/2 • 24 hours
|
|
Respiratory, thoracic and mediastinal disorders
Blocked nose
|
0.00%
0/8 • 24 hours
|
0.00%
0/4 • 24 hours
|
0.00%
0/4 • 24 hours
|
22.2%
2/9 • 24 hours
|
31.4%
11/35 • 24 hours
|
0.00%
0/15 • 24 hours
|
0.00%
0/16 • 24 hours
|
0.00%
0/2 • 24 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place