Trial Outcomes & Findings for Single Ascending Dose Challenge Study to Determine Safety and Reactogenicity of an Influenza Challenge Virus (NCT NCT04106817)
NCT ID: NCT04106817
Last Updated: 2020-01-14
Results Overview
Number of participants with viral shedding, assessed from nasopharyngeal swabs using RT-PCR and cell culture assay
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
Day 9
Results posted on
2020-01-14
Participant Flow
Study participants were enrolled at a single site in California
Enrolled participants with evidence of an infection, elevated blood pressure, or abnormal lab values prior to Day 1 did not receive the investigational virus product.
Participant milestones
| Measure |
Cohort 1
1:10 dilution of neat virus (0.25mL of 1:10 dilution per nostril of neat virus; approximate quantity 3.5 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
Cohort 2
1:5 dilution of neat virus (0.25mL of 1:5 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
Cohort 3
1:10 dilution of neat virus (0.5mL of 1:10 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
12
|
|
Overall Study
COMPLETED
|
11
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1
1:10 dilution of neat virus (0.25mL of 1:10 dilution per nostril of neat virus; approximate quantity 3.5 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
Cohort 2
1:5 dilution of neat virus (0.25mL of 1:5 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
Cohort 3
1:10 dilution of neat virus (0.5mL of 1:10 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
Single Ascending Dose Challenge Study to Determine Safety and Reactogenicity of an Influenza Challenge Virus
Baseline characteristics by cohort
| Measure |
Cohort 1
n=12 Participants
1:10 dilution of neat virus (0.25mL of 1:10 dilution per nostril of neat virus; approximate quantity 3.5 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
Cohort 2
n=11 Participants
1:5 dilution of neat virus (0.25mL of 1:5 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
Cohort 3
n=12 Participants
1:10 dilution of neat virus (0.5mL of 1:10 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38 years
n=5 Participants
|
30 years
n=7 Participants
|
29 years
n=5 Participants
|
33 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 9Number of participants with viral shedding, assessed from nasopharyngeal swabs using RT-PCR and cell culture assay
Outcome measures
| Measure |
Cohort 1
n=12 Participants
1:10 dilution of neat virus (0.25mL of 1:10 dilution per nostril of neat virus; approximate quantity 3.5 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
Cohort 2
n=11 Participants
1:5 dilution of neat virus (0.25mL of 1:5 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
Cohort 3
n=12 Participants
1:10 dilution of neat virus (0.5mL of 1:10 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
|---|---|---|---|
|
Viral Shedding
Shedding
|
8 Participants
|
4 Participants
|
7 Participants
|
|
Viral Shedding
No Shedding
|
4 Participants
|
7 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 60Greater than or equal to 4-fold rise in HAI titer by study Day 60 relative to baseline
Outcome measures
| Measure |
Cohort 1
n=11 Participants
1:10 dilution of neat virus (0.25mL of 1:10 dilution per nostril of neat virus; approximate quantity 3.5 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
Cohort 2
n=11 Participants
1:5 dilution of neat virus (0.25mL of 1:5 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
Cohort 3
n=12 Participants
1:10 dilution of neat virus (0.5mL of 1:10 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
|---|---|---|---|
|
Seroconversion
Less than 4-fold rise in HAI titer
|
5 Participants
|
5 Participants
|
4 Participants
|
|
Seroconversion
Greater than or equal to 4-fold rise in HAI titer
|
6 Participants
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 60The number of AEs in each Cohort rated as mild, moderate, or severe intensity
Outcome measures
| Measure |
Cohort 1
n=11 Participants
1:10 dilution of neat virus (0.25mL of 1:10 dilution per nostril of neat virus; approximate quantity 3.5 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
Cohort 2
n=11 Participants
1:5 dilution of neat virus (0.25mL of 1:5 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
Cohort 3
n=12 Participants
1:10 dilution of neat virus (0.5mL of 1:10 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
|---|---|---|---|
|
Number and Severity of AEs
Severe
|
0 events
|
0 events
|
0 events
|
|
Number and Severity of AEs
Mild
|
9 events
|
3 events
|
2 events
|
|
Number and Severity of AEs
Moderate
|
4 events
|
1 events
|
0 events
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=12 participants at risk
1:10 dilution of neat virus (0.25mL of 1:10 dilution per nostril of neat virus; approximate quantity 3.5 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
Cohort 2
n=11 participants at risk
1:5 dilution of neat virus (0.25mL of 1:5 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
Cohort 3
n=12 participants at risk
1:10 dilution of neat virus (0.5mL of 1:10 dilution per nostril of neat virus; approximate quantity 7 x 106TCID50/dose)
Live, wild-type A/California/H1N1 2009 influenza virus
|
|---|---|---|---|
|
General disorders
Chest discomfort/tightness
|
16.7%
2/12 • Participants were followed through Day 60 (±3) for adverse events.
AEs were defined as any untoward medical occurrence whether or not considered related to the investigational virus product. The solicited signs and symptoms of influenza will not be reported as AEs as these constitute an endpoint of the study and will be recorded as such, unless a situation arises where it is the opinion of the Investigator to do so.
|
0.00%
0/11 • Participants were followed through Day 60 (±3) for adverse events.
AEs were defined as any untoward medical occurrence whether or not considered related to the investigational virus product. The solicited signs and symptoms of influenza will not be reported as AEs as these constitute an endpoint of the study and will be recorded as such, unless a situation arises where it is the opinion of the Investigator to do so.
|
0.00%
0/12 • Participants were followed through Day 60 (±3) for adverse events.
AEs were defined as any untoward medical occurrence whether or not considered related to the investigational virus product. The solicited signs and symptoms of influenza will not be reported as AEs as these constitute an endpoint of the study and will be recorded as such, unless a situation arises where it is the opinion of the Investigator to do so.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Participants were followed through Day 60 (±3) for adverse events.
AEs were defined as any untoward medical occurrence whether or not considered related to the investigational virus product. The solicited signs and symptoms of influenza will not be reported as AEs as these constitute an endpoint of the study and will be recorded as such, unless a situation arises where it is the opinion of the Investigator to do so.
|
0.00%
0/11 • Participants were followed through Day 60 (±3) for adverse events.
AEs were defined as any untoward medical occurrence whether or not considered related to the investigational virus product. The solicited signs and symptoms of influenza will not be reported as AEs as these constitute an endpoint of the study and will be recorded as such, unless a situation arises where it is the opinion of the Investigator to do so.
|
0.00%
0/12 • Participants were followed through Day 60 (±3) for adverse events.
AEs were defined as any untoward medical occurrence whether or not considered related to the investigational virus product. The solicited signs and symptoms of influenza will not be reported as AEs as these constitute an endpoint of the study and will be recorded as such, unless a situation arises where it is the opinion of the Investigator to do so.
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Participants were followed through Day 60 (±3) for adverse events.
AEs were defined as any untoward medical occurrence whether or not considered related to the investigational virus product. The solicited signs and symptoms of influenza will not be reported as AEs as these constitute an endpoint of the study and will be recorded as such, unless a situation arises where it is the opinion of the Investigator to do so.
|
0.00%
0/11 • Participants were followed through Day 60 (±3) for adverse events.
AEs were defined as any untoward medical occurrence whether or not considered related to the investigational virus product. The solicited signs and symptoms of influenza will not be reported as AEs as these constitute an endpoint of the study and will be recorded as such, unless a situation arises where it is the opinion of the Investigator to do so.
|
0.00%
0/12 • Participants were followed through Day 60 (±3) for adverse events.
AEs were defined as any untoward medical occurrence whether or not considered related to the investigational virus product. The solicited signs and symptoms of influenza will not be reported as AEs as these constitute an endpoint of the study and will be recorded as such, unless a situation arises where it is the opinion of the Investigator to do so.
|
|
Renal and urinary disorders
Elevated liver enzymes
|
16.7%
2/12 • Participants were followed through Day 60 (±3) for adverse events.
AEs were defined as any untoward medical occurrence whether or not considered related to the investigational virus product. The solicited signs and symptoms of influenza will not be reported as AEs as these constitute an endpoint of the study and will be recorded as such, unless a situation arises where it is the opinion of the Investigator to do so.
|
0.00%
0/11 • Participants were followed through Day 60 (±3) for adverse events.
AEs were defined as any untoward medical occurrence whether or not considered related to the investigational virus product. The solicited signs and symptoms of influenza will not be reported as AEs as these constitute an endpoint of the study and will be recorded as such, unless a situation arises where it is the opinion of the Investigator to do so.
|
0.00%
0/12 • Participants were followed through Day 60 (±3) for adverse events.
AEs were defined as any untoward medical occurrence whether or not considered related to the investigational virus product. The solicited signs and symptoms of influenza will not be reported as AEs as these constitute an endpoint of the study and will be recorded as such, unless a situation arises where it is the opinion of the Investigator to do so.
|
|
Respiratory, thoracic and mediastinal disorders
Cold symptoms
|
8.3%
1/12 • Participants were followed through Day 60 (±3) for adverse events.
AEs were defined as any untoward medical occurrence whether or not considered related to the investigational virus product. The solicited signs and symptoms of influenza will not be reported as AEs as these constitute an endpoint of the study and will be recorded as such, unless a situation arises where it is the opinion of the Investigator to do so.
|
9.1%
1/11 • Participants were followed through Day 60 (±3) for adverse events.
AEs were defined as any untoward medical occurrence whether or not considered related to the investigational virus product. The solicited signs and symptoms of influenza will not be reported as AEs as these constitute an endpoint of the study and will be recorded as such, unless a situation arises where it is the opinion of the Investigator to do so.
|
16.7%
2/12 • Participants were followed through Day 60 (±3) for adverse events.
AEs were defined as any untoward medical occurrence whether or not considered related to the investigational virus product. The solicited signs and symptoms of influenza will not be reported as AEs as these constitute an endpoint of the study and will be recorded as such, unless a situation arises where it is the opinion of the Investigator to do so.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place