Trial Outcomes & Findings for Influenza A 2009 H1N1 Challenge Study in Healthy Adults (NCT NCT01646138)
NCT ID: NCT01646138
Last Updated: 2016-05-09
Results Overview
Percent of individuals experiencing mild to moderate influenza infection (MMID, defined as active shedding and symptoms of influenza A) in each dosing group.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
49 participants
Primary outcome timeframe
67 days after influenza inoculation
Results posted on
2016-05-09
Participant Flow
49 participants were enrolled but 1 participant did not receive the intervention.
Participant milestones
| Measure |
10^3 TCID 50
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10\^3 TCID50 in 1ml given intranasally.
|
10^4 TCID 50
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10\^4 TCID50 in 1ml given intranasally.
|
10^5 TCID 50
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10\^5 TCID50 in 1ml given intranasally.
|
10^6 TCID 50
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10\^6 TCID50 in 1ml given intranasally.
|
10^7 TCID 50
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10\^7 TCID50 in 1ml given intranasally.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
5
|
19
|
15
|
|
Overall Study
COMPLETED
|
5
|
4
|
5
|
19
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
10^3 TCID 50
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10\^3 TCID50 in 1ml given intranasally.
|
10^4 TCID 50
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10\^4 TCID50 in 1ml given intranasally.
|
10^5 TCID 50
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10\^5 TCID50 in 1ml given intranasally.
|
10^6 TCID 50
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10\^6 TCID50 in 1ml given intranasally.
|
10^7 TCID 50
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10\^7 TCID50 in 1ml given intranasally.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Influenza A 2009 H1N1 Challenge Study in Healthy Adults
Baseline characteristics by cohort
| Measure |
10^3 TCID 50
n=5 Participants
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10\^3 TCID50 in 1ml given intranasally.
|
10^4 TCID 50
n=4 Participants
Participants received influenza A(H1N1) pdm09 at a dose of 10\^4 TCID50 administered intranasally.
|
10^5 TCID 50
n=5 Participants
Participants received influenza A(H1N1) pdm09 at a dose of 10\^5 TCID50 administered intranasally.
|
10^6 TCID 50
n=20 Participants
Participants received influenza A(H1N1) pdm09 at a dose of 10\^6 TCID50 administered intranasally.
|
10^7 TCID 50
n=15 Participants
Participants received influenza A(H1N1) pdm09 at a dose of 10\^7 TCID50 administered intranasally.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
49 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
19 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
30 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
46 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
26 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
19 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 67 days after influenza inoculationPopulation: Analysis of the subjects who completed the study after receiving a particular dose of Ca/04/2009/H1N1 Vero Grown Challenge Virus.
Percent of individuals experiencing mild to moderate influenza infection (MMID, defined as active shedding and symptoms of influenza A) in each dosing group.
Outcome measures
| Measure |
10^3 TCID 50
n=5 Participants
Participants received influenza A(H1N1) pdm09 at a dose of 10\^3 TCID 50 administered intranasally.
|
10^4 TCID 50
n=4 Participants
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10\^4 TCID50 in 1ml given intranasally.
|
10^5 TCID 50
n=5 Participants
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10\^5 TCID50 in 1ml given intranasally.
|
10^6 TCID 50
n=19 Participants
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10\^6 TCID50 in 1ml given intranasally.
|
10^7 TCID 50
n=13 Participants
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10\^7 TCID50 in 1ml given intranasally.
|
|---|---|---|---|---|---|
|
Percent MMID
|
0 percentage of participants
|
0 percentage of participants
|
20 percentage of participants
|
47 percentage of participants
|
69 percentage of participants
|
Adverse Events
10^3 TCID 50
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
10^4 TCID 50
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
10^5 TCID 50
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
10^6 TCID 50
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
10^7 TCID 50
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
10^3 TCID 50
n=5 participants at risk
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10\^3 TCID50 in 1ml given intranasally.
|
10^4 TCID 50
n=4 participants at risk
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10\^4 TCID50 in 1ml given intranasally.
|
10^5 TCID 50
n=5 participants at risk
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10\^5 TCID50 in 1ml given intranasally.
|
10^6 TCID 50
n=19 participants at risk
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10\^6 TCID50 in 1ml given intranasally.
|
10^7 TCID 50
n=15 participants at risk
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10\^7 TCID50 in 1ml given intranasally.
|
|---|---|---|---|---|---|
|
Eye disorders
Photophobia
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/19
|
6.7%
1/15
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/19
|
6.7%
1/15
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/19
|
6.7%
1/15
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/19
|
0.00%
0/15
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
5.3%
1/19
|
0.00%
0/15
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
5.3%
1/19
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
5.3%
1/19
|
0.00%
0/15
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5
|
25.0%
1/4
|
0.00%
0/5
|
0.00%
0/19
|
0.00%
0/15
|
|
Investigations
Blood creatine phosphokinase
|
0.00%
0/5
|
25.0%
1/4
|
0.00%
0/5
|
0.00%
0/19
|
13.3%
2/15
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
10.5%
2/19
|
0.00%
0/15
|
|
Investigations
Blood urea increased
|
20.0%
1/5
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/19
|
0.00%
0/15
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
5.3%
1/19
|
0.00%
0/15
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
10.5%
2/19
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
5.3%
1/19
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
20.0%
1/5
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/19
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5
|
25.0%
1/4
|
0.00%
0/5
|
0.00%
0/19
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
20.0%
1/5
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/19
|
0.00%
0/15
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/19
|
6.7%
1/15
|
|
Nervous system disorders
Presyncope
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/19
|
6.7%
1/15
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
5.3%
1/19
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/19
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/19
|
6.7%
1/15
|
Additional Information
Matthew J. Memoli
National Institute of Allergy and Infectious Diseases
Phone: +1 301 443 5971
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place