Trial Outcomes & Findings for A First-in-Human Safety and Dose-Finding Study of New Type-16 Human Rhinovirus (RG-HRV16) Inoculum in Healthy Volunteers (NCT NCT01769573)
NCT ID: NCT01769573
Last Updated: 2019-06-03
Results Overview
The percentage of colds of at least moderate intensity examined by RG-HRV16 dose; this will be measured by the number of subjects per RG-HRV16 dose group who have maximum weekly cold symptom score of ≥7 out of 39 on the modified Jackson criteria during the first week after inoculation
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
1 week
Results posted on
2019-06-03
Participant Flow
Participant milestones
| Measure |
100 TCID50
RG-HRV16 dose of 100 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
500 TCID50
RG-HRV16 dose of 500 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
1,000 TCID50
RG-HRV16 dose of 1,000 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
10,000 TCID50
RG-HRV16 dose of 10,000 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
Placebo
Diluent administered intranasally (0.25ml per nostril) one time.
Placebo: The placebo to be used will be Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin. Placebo will be supplied in 2 ml borosilicate glass vials sealed with butyl stoppers containing 0.5 ml.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
10
|
0
|
10
|
|
Overall Study
COMPLETED
|
10
|
6
|
10
|
0
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A First-in-Human Safety and Dose-Finding Study of New Type-16 Human Rhinovirus (RG-HRV16) Inoculum in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
100 TCID50
n=10 Participants
RG-HRV16 dose of 100 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
500 TCID50
n=6 Participants
RG-HRV16 dose of 500 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
1,000 TCID50
n=10 Participants
RG-HRV16 dose of 1,000 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
10,000 TCID50
RG-HRV16 dose of 10,000 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
Placebo
n=10 Participants
Diluent administered intranasally (0.25ml per nostril) one time.
Placebo: The placebo to be used will be Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin. Placebo will be supplied in 2 ml borosilicate glass vials sealed with butyl stoppers containing 0.5 ml.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
36 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
—
|
10 participants
n=21 Participants
|
36 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: The trial completed and met its goal before needing to enroll into the 10,000 TCID50 group.
The percentage of colds of at least moderate intensity examined by RG-HRV16 dose; this will be measured by the number of subjects per RG-HRV16 dose group who have maximum weekly cold symptom score of ≥7 out of 39 on the modified Jackson criteria during the first week after inoculation
Outcome measures
| Measure |
100 TCID50
n=10 Participants
RG-HRV16 dose of 100 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
500 TCID50
n=6 Participants
RG-HRV16 dose of 500 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
1,000 TCID50
n=10 Participants
RG-HRV16 dose of 1,000 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
10,000 TCID50
RG-HRV16 dose of 10,000 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
Placebo
n=10 Participants
Diluent administered intranasally (0.25ml per nostril) one time.
Placebo: The placebo to be used will be Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin. Placebo will be supplied in 2 ml borosilicate glass vials sealed with butyl stoppers containing 0.5 ml.
|
|---|---|---|---|---|---|
|
Number of Participants With Colds With at Least Moderate Intensity
|
4 Participants
|
2 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The trial completed and met its goal before needing to enroll into the 10,000 TCID50 group.
Safety as determined by the frequency of adverse event reporting examined by RG-HRV16 dose.
Outcome measures
| Measure |
100 TCID50
n=10 Participants
RG-HRV16 dose of 100 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
500 TCID50
n=6 Participants
RG-HRV16 dose of 500 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
1,000 TCID50
n=10 Participants
RG-HRV16 dose of 1,000 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
10,000 TCID50
RG-HRV16 dose of 10,000 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
Placebo
n=10 Participants
Diluent administered intranasally (0.25ml per nostril) one time.
Placebo: The placebo to be used will be Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin. Placebo will be supplied in 2 ml borosilicate glass vials sealed with butyl stoppers containing 0.5 ml.
|
|---|---|---|---|---|---|
|
Frequency of Adverse Events
|
4 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: For the manuscript, the 500 TCID50 group was excluded from this analysis due to incomplete data that could not be analyzed appropriately. The trial completed and met its goal before needing to enroll into the 10,000 TCID50 group.
The Mean Cold Symptom Score induced by each RG-HRV16 dose and by the placebo inoculation. The scale is called the Jackson Criteria for Cold Symptom Assessment. There are 13 variables of cold symptoms that each participant scores 0 (not present), 1 (mild), 2 (moderate) to 3 (severe), twice per day, once at 8am and once at 8pm. The 13 variables are: cough, nasal discharge, sneezing, stuffy nose, sore throat, headache, malaise, chilliness, shaking chills, fever, laryngitis, aching joints or muscles, and watery/burning eyes. The scores are added up for each time point, with a minimum score of 0 and a max score of 39 per time point. The highest score per day is taken and the highest score over the 7 day period starting from the day of the inoculation and for 7 days is deemed the mean cold symptom score. The higher the score, the more cold symptoms the participant reports and the worse the participant feels.
Outcome measures
| Measure |
100 TCID50
n=10 Participants
RG-HRV16 dose of 100 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
500 TCID50
n=6 Participants
RG-HRV16 dose of 500 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
1,000 TCID50
n=10 Participants
RG-HRV16 dose of 1,000 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
10,000 TCID50
RG-HRV16 dose of 10,000 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
Placebo
n=10 Participants
Diluent administered intranasally (0.25ml per nostril) one time.
Placebo: The placebo to be used will be Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin. Placebo will be supplied in 2 ml borosilicate glass vials sealed with butyl stoppers containing 0.5 ml.
|
|---|---|---|---|---|---|
|
Mean Cold Symptom Score
|
7.5 peak symptom score
Standard Deviation 5.0
|
7.3 peak symptom score
Standard Deviation 1.9
|
11.4 peak symptom score
Standard Deviation 7.8
|
—
|
1.9 peak symptom score
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The trial completed and met its goal before needing to enroll into the 10,000 TCID50 group.
Infection rate per RG-HRV16 dose as measured by the percentage of individuals in the dosing group with detectable viral shedding.
Outcome measures
| Measure |
100 TCID50
n=10 Participants
RG-HRV16 dose of 100 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
500 TCID50
n=6 Participants
RG-HRV16 dose of 500 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
1,000 TCID50
n=10 Participants
RG-HRV16 dose of 1,000 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
10,000 TCID50
RG-HRV16 dose of 10,000 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
Placebo
n=10 Participants
Diluent administered intranasally (0.25ml per nostril) one time.
Placebo: The placebo to be used will be Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin. Placebo will be supplied in 2 ml borosilicate glass vials sealed with butyl stoppers containing 0.5 ml.
|
|---|---|---|---|---|---|
|
Infection Rate
|
10 Participants
|
6 Participants
|
10 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
100 TCID50
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
500 TCID50
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1,000 TCID50
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
10,000 TCID50
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
100 TCID50
n=10 participants at risk
RG-HRV16 dose of 100 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
500 TCID50
n=6 participants at risk
RG-HRV16 dose of 500 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
1,000 TCID50
n=10 participants at risk
RG-HRV16 dose of 1,000 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
10,000 TCID50
RG-HRV16 dose of 10,000 TCID50 administered intranasally (0.25ml per nostril) one time.
RG-HRV16: A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
|
Placebo
n=10 participants at risk
Diluent administered intranasally (0.25ml per nostril) one time.
Placebo: The placebo to be used will be Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin. Placebo will be supplied in 2 ml borosilicate glass vials sealed with butyl stoppers containing 0.5 ml.
|
|---|---|---|---|---|---|
|
General disorders
Headache
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
16.7%
1/6 • Number of events 1 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
—
0/0 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
|
General disorders
Migraine
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/6 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
—
0/0 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
10.0%
1/10 • Number of events 1 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
10.0%
1/10 • Number of events 1 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/6 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
—
0/0 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
16.7%
1/6 • Number of events 1 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
—
0/0 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Muscle soreness
|
10.0%
1/10 • Number of events 1 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/6 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
—
0/0 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
|
Immune system disorders
IgA < 50 mg/dl
|
10.0%
1/10 • Number of events 1 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/6 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
—
0/0 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
|
Cardiac disorders
Heart rate < or equal to 54
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/6 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
10.0%
1/10 • Number of events 2 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
—
0/0 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
|
Cardiac disorders
Heart rate > or equal to 101
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/6 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
20.0%
2/10 • Number of events 2 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
—
0/0 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
10.0%
1/10 • Number of events 2 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
10.0%
1/10 • Number of events 1 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/6 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
—
0/0 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Nasal pain
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
16.7%
1/6 • Number of events 1 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
—
0/0 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/6 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
10.0%
1/10 • Number of events 1 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
—
0/0 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
|
Eye disorders
Blepharitis to right eye
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/6 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
10.0%
1/10 • Number of events 1 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
—
0/0 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
|
Infections and infestations
Crusted upper lip vesicle
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/6 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
10.0%
1/10 • Number of events 1 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
—
0/0 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
|
Blood and lymphatic system disorders
Lymph node swelling
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/6 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
10.0%
1/10 • Number of events 1 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
—
0/0 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
0.00%
0/10 • From date of signed consent until completion of study or roughly 60 days.
No participants were enrolled in the 10,000 TCID50 group as the study met its goals early. All other groups report that all participants were at risk for Other Adverse Events, All-Cause Mortality and Serious Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place