Trial Outcomes & Findings for A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children With Respiratory Syncytial Virus (RSV) Illness (NCT NCT00435227)
NCT ID: NCT00435227
Last Updated: 2021-08-17
Results Overview
The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Day 0
Results posted on
2021-08-17
Participant Flow
The study was conducted from 20Mar2007 to 31May2008 in the United States of America.
A total of 12 participants were randomized in the study.
Participant milestones
| Measure |
Placebo
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
|
Overall Study
COMPLETED
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children With Respiratory Syncytial Virus (RSV) Illness
Baseline characteristics by cohort
| Measure |
Placebo
n=5 Participants
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
n=7 Participants
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3.78 Months
STANDARD_DEVIATION 1.97 • n=5 Participants
|
5.79 Months
STANDARD_DEVIATION 3.68 • n=7 Participants
|
4.95 Months
STANDARD_DEVIATION 3.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0Population: Intent-to-treat population included all participants who were randomized in the study. Participants who were RSV-positive at Day 0 were analyzed for this outcome.
The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
n=5 Participants
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
|---|---|---|
|
Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by Reverse Transcriptase-polymerase Chain Reaction (RT-PCR) at Day 0
|
5.877 log10 copies/mL
Standard Deviation 1.503
|
6.657 log10 copies/mL
Standard Deviation 0.999
|
PRIMARY outcome
Timeframe: Day 2Population: Intent-to-treat population included all participants who were randomized in the study. Participants who were RSV-positive at Day 2 were analyzed for this outcome.
The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
n=4 Participants
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
|---|---|---|
|
RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 2
|
5.070 log10 copies/mL
Standard Deviation 1.905
|
5.854 log10 copies/mL
Standard Deviation 1.855
|
PRIMARY outcome
Timeframe: Day 30Population: Intent-to-treat population included all participants who were randomized in the study. Participants who were RSV-positive at Day 30 were analyzed for this outcome.
The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
n=5 Participants
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
|---|---|---|
|
RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 30
|
2.500 log10 copies/mL
Standard Deviation 0.000
|
2.640 log10 copies/mL
Standard Deviation 0.312
|
PRIMARY outcome
Timeframe: Day 90Population: Intent-to-treat population included all participants who were randomized in the study. Participants who were RSV-positive at Day 90 were analyzed for this outcome.
The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
n=5 Participants
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
|---|---|---|
|
RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 90
|
2.500 log10 copies/mL
Standard Deviation 0.000
|
2.500 log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: From Randomiation (Day 0) Up to Day 30Population: Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR.
The percentage of participants who have progression of RSV illness that requires subsequent hospitalization is reported. RSV illness symptomps included fever, coryza, cough, and parental opinion of return to normal health and activity.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
n=5 Participants
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
|---|---|---|
|
Percentage of Participants Who Have Progression of RSV Illness That Requires Subsequent Hospitalization
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0); and Days 2, 7, and 30Population: Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR.
The RACS assesses changes in wheezing and retractions as measured by the respiratory distress assessment instrument (RDAI) score and changes in respiratory rate. A RDAI score is a measure of the degree of severity of wheezing and retractions, with score range from 0 to 17; higher scores indicate more severe disease. Respiratory rate is summarized by raw scores and standardized change score. Change in respiratory rate of less than or equal to (\<=) 5% from baseline is counted as a change of 0 units and a change in respiratory rate is assigned 1 point per each 10% change in respiratory rate. The RACS is calculated as arithmetic sum of RDAI score change and of the standardized respiratory rate change (for example, a child showing improvement who had a RDAI of -5 and a respiratory rate change of -2 would have a RACS score of -7). The RACS assessment does not have a minimum and/or maximum scale range. A decrease in RACS represents improvement, whereas an increase signifies deterioration.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
n=5 Participants
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
|---|---|---|
|
Respiratory Assessment Change Score (RACS) Derived From Baseline
Day 2
|
1.80 Units on a score
Standard Deviation 4.09
|
2.20 Units on a score
Standard Deviation 5.81
|
|
Respiratory Assessment Change Score (RACS) Derived From Baseline
Day 7
|
-0.20 Units on a score
Standard Deviation 4.82
|
-2.00 Units on a score
Standard Deviation 1.58
|
|
Respiratory Assessment Change Score (RACS) Derived From Baseline
Day 30
|
-1.40 Units on a score
Standard Deviation 4.51
|
-2.00 Units on a score
Standard Deviation 4.18
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Days 2, 7, and 30Population: Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR.
Change from baseline in oxygen saturation level is reported.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
n=5 Participants
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
|---|---|---|
|
Change From Baseline in Oxygen Saturation Level
Day 2
|
1.00 Percentage of oxygen saturation
Standard Deviation 1.73
|
-1.00 Percentage of oxygen saturation
Standard Deviation 1.58
|
|
Change From Baseline in Oxygen Saturation Level
Day 7
|
1.20 Percentage of oxygen saturation
Standard Deviation 2.17
|
0.60 Percentage of oxygen saturation
Standard Deviation 1.34
|
|
Change From Baseline in Oxygen Saturation Level
Day 30
|
1.80 Percentage of oxygen saturation
Standard Deviation 1.48
|
0.40 Percentage of oxygen saturation
Standard Deviation 1.52
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 30Population: Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Data were not collected as no participants required hospitalization.
The RACS assesses changes in wheezing and retractions as measured by the RDAI score and changes in respiratory rate. A RDAI score is a measure of the degree of severity of wheezing and retractions, with score range from 0 to 17; higher scores indicate more severe disease. Respiratory rate is summarized by raw scores and standardized change score. A change in respiratory rate of \<= 5% from baseline is counted as a change of 0 units and a change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate. The RACS is calculated as the arithmetic sum of the RDAI score change and of the standardized respiratory rate change (for example, a child showing improvement who had a RDAI of -5 and a respiratory rate change of -2 would have a RACS score of -7). The RACS assessment does not have a minimum and/or maximum scale range. A decrease in the RACS represents improvement, whereas an increase signifies deterioration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 30Population: Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Data were not collected as no participants required hospitalization.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 30Population: Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Data were not collected as no participants required hospitalization.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 30Population: Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Data were not collected as no participants required hospitalization.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 90Population: Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR.
Number of participants who required hospitalization, ICU stay, supplemental oxygen, and mechanical ventilation is reported.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
n=5 Participants
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
|---|---|---|
|
Number of Participants Who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical Ventilation
Hospitalization
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical Ventilation
Supplemental oxygen
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical Ventilation
Mechanical ventilation
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical Ventilation
ICU stay
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 90Population: Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Data were not collected as no participants were hospitalized or received intensive care or supplemental oxygen, or mechanical ventilation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 30Population: Safety population included all participants who had received any study drug and had any follow-up.
A LRI event is one that has a medical diagnosis of bronchiolitis or pneumonia. In the absence of such a medical diagnosis, the occurrence of LRI events will be determined by the principal investigator after review of the medical record and based on the presence of retractions or lower respiratory tract rhonchi, wheezing, crackles, or rales in children with a positive RSV test.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
n=7 Participants
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
|---|---|---|
|
Number of Participants Who Progresses From Upper Respiratory Tract Infection to Lower Respiratory Tract Infection (LRI)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 30Population: Safety population included all participants who had received any study drug and had any follow-up. Participants with LRI were analyzed for this outcome.
Number of LRI infected participants who required hospitalization, ICU stay, supplemental oxygen, mechanical ventilation, and respiratory medications are reported.
Outcome measures
| Measure |
Placebo
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
n=1 Participants
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
|---|---|---|
|
Number of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory Medications
Hospitalization
|
0 Participants
|
0 Participants
|
|
Number of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory Medications
Supplemental oxygen
|
0 Participants
|
0 Participants
|
|
Number of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory Medications
Mechanical ventilation
|
0 Participants
|
0 Participants
|
|
Number of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory Medications
ICU stay
|
0 Participants
|
0 Participants
|
|
Number of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory Medications
Respiratory medication
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 0) to Days 2, 7, and 30Population: Safety population included all participants who had received any study drug and had any follow-up. Participants with LRI were analyzed for this outcome.
The RACS assesses changes in wheezing and retractions as measured by RDAI score and changes in respiratory rate. A RDAI score is a measure of degree of severity of wheezing and retractions, with score range from 0 to 17; higher scores indicate more severe disease. Respiratory rate is summarized by raw scores and standardized change score. A change in respiratory rate of \<= 5% from baseline is counted as a change of 0 units and a change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate. The RACS is calculated as the arithmetic sum of the RDAI score change and of the standardized respiratory rate change (for example, a child showing improvement who had a RDAI of -5 and a respiratory rate change of -2 would have a RACS score of -7). The RACS assessment does not have a minimum and/or maximum scale range. A decrease in the RACS represents improvement, whereas an increase signifies deterioration. RACS in participants with LRI is reported.
Outcome measures
| Measure |
Placebo
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
n=1 Participants
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
|---|---|---|
|
RACS in Participants With LRI
Day 2
|
—
|
12 Units on a score
Standard Deviation NA
Standard deviation data was not applicable as only one participant was evaluable for the specified outcome measure.
|
|
RACS in Participants With LRI
Day 7
|
—
|
-4 Units on a score
Standard Deviation NA
Standard deviation data was not applicable as only one participant was evaluable for the specified outcome measure.
|
|
RACS in Participants With LRI
Day 30
|
—
|
-1 Units on a score
Standard Deviation NA
Standard deviation data was not applicable as only one participant was evaluable for the specified outcome measure.
|
SECONDARY outcome
Timeframe: Days 0 (pre-dose), 2, and 30Population: Evaluable population for pharmacokinetic (PK) included all participants who have received a full dose of study drug.
Motavizumab concentration in upper respiratory tract (nasal wash aspirates) is reported.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
|---|---|---|
|
Motavizumab Concentration in Upper Respiratory Tract
Day 0
|
NA ng/mL
Standard Deviation NA
The data was not reported as the concentration was below the level of detection.
|
—
|
|
Motavizumab Concentration in Upper Respiratory Tract
Day 2
|
1216.186 ng/mL
Standard Deviation 1828.934
|
—
|
|
Motavizumab Concentration in Upper Respiratory Tract
Day 30
|
348.256 ng/mL
Standard Deviation 507.979
|
—
|
SECONDARY outcome
Timeframe: Days 2, 30, and 90Population: Evaluable population for PK included all participants who have received a full dose of study drug.
Serum concentration of motavizumab is reported.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
|---|---|---|
|
Serum Concentration of Motavizumab
Day 2
|
216.761 mcg/mL
Standard Deviation 43.867
|
—
|
|
Serum Concentration of Motavizumab
Day 30
|
126.296 mcg/mL
Standard Deviation 25.013
|
—
|
|
Serum Concentration of Motavizumab
Day 90
|
23.799 mcg/mL
Standard Deviation 9.810
|
—
|
SECONDARY outcome
Timeframe: Days 0 (pre-dose) and 90Population: Evaluable population for ADA included all participants who have received a full dose of study drug. Participants with adequate ADA samples were analysed for this outcome measure.
The number of participants with positive serum antibodies to motavizumab are reported.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
|---|---|---|
|
Numbers of Participants With Positive Anti-Motavizumab Antibodies
Day 0
|
0 Participants
|
—
|
|
Numbers of Participants With Positive Anti-Motavizumab Antibodies
Day 90
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Days 0 (pre-dose), 30, and 90Population: Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Participants with adequate cytokine levels at specified time points were analyzed for this outcome.
Serum Cytokine Levels are reported.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
n=5 Participants
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
|---|---|---|
|
Serum Cytokine Levels
Interleukin 1 (IL-1) beta: Day 0
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-1 beta: Day 30
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-1 beta: Day 90
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-1 receptor antagonist (RA): Day 0
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-1 RA: Day 30
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-1 RA: Day 90
|
11.000 Picograms per millilitre (pg/mL)
Standard Deviation 6.000
|
10.960 Picograms per millilitre (pg/mL)
Standard Deviation 6.619
|
|
Serum Cytokine Levels
IL-2: Day 0
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-2: Day 30
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-2: Day 90
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-4: Day 0
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-4: Day 30
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-4: Day 90
|
10.900 Picograms per millilitre (pg/mL)
Standard Deviation 5.800
|
13.060 Picograms per millilitre (pg/mL)
Standard Deviation 11.315
|
|
Serum Cytokine Levels
IL-5: Day 0
|
1.600 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
1.600 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-5: Day 30
|
1.600 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
1.600 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-5: Day 90
|
19.925 Picograms per millilitre (pg/mL)
Standard Deviation 35.460
|
3.080 Picograms per millilitre (pg/mL)
Standard Deviation 3.309
|
|
Serum Cytokine Levels
IL-6: Day 0
|
2.620 Picograms per millilitre (pg/mL)
Standard Deviation 2.281
|
12.025 Picograms per millilitre (pg/mL)
Standard Deviation 8.247
|
|
Serum Cytokine Levels
IL-6: Day 30
|
1.600 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
1.980 Picograms per millilitre (pg/mL)
Standard Deviation 0.850
|
|
Serum Cytokine Levels
IL-6: Day 90
|
22.950 Picograms per millilitre (pg/mL)
Standard Deviation 16.093
|
4.040 Picograms per millilitre (pg/mL)
Standard Deviation 3.335
|
|
Serum Cytokine Levels
IL-7: Day 0
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-7: Day 30
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-7: Day 90
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-8: Day 0
|
28.500 Picograms per millilitre (pg/mL)
Standard Deviation 1.728
|
28.525 Picograms per millilitre (pg/mL)
Standard Deviation 14.061
|
|
Serum Cytokine Levels
IL-8: Day 30
|
12.900 Picograms per millilitre (pg/mL)
Standard Deviation 4.678
|
7.900 Picograms per millilitre (pg/mL)
Standard Deviation 2.904
|
|
Serum Cytokine Levels
IL-8: Day 90
|
38.475 Picograms per millilitre (pg/mL)
Standard Deviation 43.752
|
12.120 Picograms per millilitre (pg/mL)
Standard Deviation 4.727
|
|
Serum Cytokine Levels
IL-9: Day 0
|
1.600 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
1.600 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-9: Day 30
|
1.600 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
3.020 Picograms per millilitre (pg/mL)
Standard Deviation 3.175
|
|
Serum Cytokine Levels
IL-9: Day 90
|
7.925 Picograms per millilitre (pg/mL)
Standard Deviation 6.758
|
4.200 Picograms per millilitre (pg/mL)
Standard Deviation 4.591
|
|
Serum Cytokine Levels
IL-10: Day 0
|
36.400 Picograms per millilitre (pg/mL)
Standard Deviation 28.205
|
29.625 Picograms per millilitre (pg/mL)
Standard Deviation 31.852
|
|
Serum Cytokine Levels
IL-10: Day 30
|
19.325 Picograms per millilitre (pg/mL)
Standard Deviation 13.297
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-10: Day 90
|
13.900 Picograms per millilitre (pg/mL)
Standard Deviation 7.161
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-11: Day 0
|
13.133 Picograms per millilitre (pg/mL)
Standard Deviation 5.860
|
9.750 Picograms per millilitre (pg/mL)
Standard Deviation NA
Standard deviation is not applicable as only one participant was evaluable for the specified time point.
|
|
Serum Cytokine Levels
IL-11: Day 30
|
15.600 Picograms per millilitre (pg/mL)
Standard Deviation 10.132
|
27.000 Picograms per millilitre (pg/mL)
Standard Deviation 29.878
|
|
Serum Cytokine Levels
IL-11: Day 90
|
148.483 Picograms per millilitre (pg/mL)
Standard Deviation 143.545
|
38.783 Picograms per millilitre (pg/mL)
Standard Deviation 32.632
|
|
Serum Cytokine Levels
IL-12 P70: Day 0
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-12 P70: Day 30
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-12 P70: Day 90
|
20.450 Picograms per millilitre (pg/mL)
Standard Deviation 24.900
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-13: Day 0
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-13: Day 30
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-13: Day 90
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
11.060 Picograms per millilitre (pg/mL)
Standard Deviation 6.842
|
|
Serum Cytokine Levels
IL-15: Day 0
|
1.600 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
1.600 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-15: Day 30
|
1.600 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
1.600 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-15: Day 90
|
2.100 Picograms per millilitre (pg/mL)
Standard Deviation 1.000
|
1.600 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-17: Day 0
|
2.160 Picograms per millilitre (pg/mL)
Standard Deviation 1.252
|
1.600 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-17: Day 30
|
2.675 Picograms per millilitre (pg/mL)
Standard Deviation 2.150
|
1.600 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IL-17: Day 90
|
29.875 Picograms per millilitre (pg/mL)
Standard Deviation 37.289
|
5.180 Picograms per millilitre (pg/mL)
Standard Deviation 6.324
|
|
Serum Cytokine Levels
Eotaxin: Day 0
|
120.860 Picograms per millilitre (pg/mL)
Standard Deviation 53.095
|
116.325 Picograms per millilitre (pg/mL)
Standard Deviation 15.866
|
|
Serum Cytokine Levels
Eotaxin: Day 30
|
117.500 Picograms per millilitre (pg/mL)
Standard Deviation 54.553
|
105.720 Picograms per millilitre (pg/mL)
Standard Deviation 19.212
|
|
Serum Cytokine Levels
Eotaxin: Day 90
|
139.275 Picograms per millilitre (pg/mL)
Standard Deviation 32.062
|
87.960 Picograms per millilitre (pg/mL)
Standard Deviation 29.430
|
|
Serum Cytokine Levels
Interferon (IFN) gamma: Day 0
|
16.020 Picograms per millilitre (pg/mL)
Standard Deviation 10.991
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IFN gamma: Day 30
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
IFN gamma: Day 90
|
115.675 Picograms per millilitre (pg/mL)
Standard Deviation 125.181
|
14.740 Picograms per millilitre (pg/mL)
Standard Deviation 10.698
|
|
Serum Cytokine Levels
IFN alpha 2: Day 0
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
12.000 Picograms per millilitre (pg/mL)
Standard Deviation 8.000
|
|
Serum Cytokine Levels
IFN alpha 2: Day 30
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
12.060 Picograms per millilitre (pg/mL)
Standard Deviation 9.078
|
|
Serum Cytokine Levels
IFN alpha 2: Day 90
|
20.175 Picograms per millilitre (pg/mL)
Standard Deviation 24.350
|
12.220 Picograms per millilitre (pg/mL)
Standard Deviation 5.792
|
|
Serum Cytokine Levels
IFN gamma induced protein (IP)-10: Day 0
|
605.740 Picograms per millilitre (pg/mL)
Standard Deviation 299.105
|
723.950 Picograms per millilitre (pg/mL)
Standard Deviation 442.489
|
|
Serum Cytokine Levels
IP-10: Day 30
|
518.775 Picograms per millilitre (pg/mL)
Standard Deviation 617.131
|
136.360 Picograms per millilitre (pg/mL)
Standard Deviation 59.356
|
|
Serum Cytokine Levels
IP-10: Day 90
|
310.150 Picograms per millilitre (pg/mL)
Standard Deviation 154.371
|
287.000 Picograms per millilitre (pg/mL)
Standard Deviation 58.101
|
|
Serum Cytokine Levels
Monocyte Chemoattractant Protein-1 (MCP-1): Day 0
|
729.860 Picograms per millilitre (pg/mL)
Standard Deviation 248.023
|
717.850 Picograms per millilitre (pg/mL)
Standard Deviation 585.336
|
|
Serum Cytokine Levels
MCP-1: Day 30
|
728.225 Picograms per millilitre (pg/mL)
Standard Deviation 245.660
|
727.620 Picograms per millilitre (pg/mL)
Standard Deviation 635.702
|
|
Serum Cytokine Levels
MCP-1: Day 90
|
596.125 Picograms per millilitre (pg/mL)
Standard Deviation 154.409
|
542.320 Picograms per millilitre (pg/mL)
Standard Deviation 294.697
|
|
Serum Cytokine Levels
Macrophage inflammatory protein (MIP)-1 alpha:Day0
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
MIP-1 alpha:Day 30
|
10.000 Picograms per millilitre (pg/mL)
Standard Deviation 4.000
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
MIP-1 alpha: Day 90
|
25.375 Picograms per millilitre (pg/mL)
Standard Deviation 15.504
|
8.000 Picograms per millilitre (pg/mL)
Standard Deviation 0.000
|
|
Serum Cytokine Levels
MIP-1 beta: Day 0
|
99.560 Picograms per millilitre (pg/mL)
Standard Deviation 40.959
|
70.150 Picograms per millilitre (pg/mL)
Standard Deviation 40.912
|
|
Serum Cytokine Levels
MIP-1 beta: Day 30
|
92.513 Picograms per millilitre (pg/mL)
Standard Deviation 52.444
|
95.700 Picograms per millilitre (pg/mL)
Standard Deviation 58.140
|
|
Serum Cytokine Levels
MIP-1 beta: Day 90
|
117.300 Picograms per millilitre (pg/mL)
Standard Deviation 43.226
|
77.780 Picograms per millilitre (pg/mL)
Standard Deviation 39.844
|
|
Serum Cytokine Levels
Rantes: Day 0
|
23103.400 Picograms per millilitre (pg/mL)
Standard Deviation 10200.333
|
35348.767 Picograms per millilitre (pg/mL)
Standard Deviation 11488.336
|
|
Serum Cytokine Levels
Rantes: Day 30
|
26038.788 Picograms per millilitre (pg/mL)
Standard Deviation 3942.021
|
29950.000 Picograms per millilitre (pg/mL)
Standard Deviation 13143.128
|
|
Serum Cytokine Levels
Rantes: Day 90
|
41813.725 Picograms per millilitre (pg/mL)
Standard Deviation 45065.022
|
30770.200 Picograms per millilitre (pg/mL)
Standard Deviation 15335.152
|
|
Serum Cytokine Levels
TNF alpha: Day 0
|
25.320 Picograms per millilitre (pg/mL)
Standard Deviation 9.373
|
23.075 Picograms per millilitre (pg/mL)
Standard Deviation 4.802
|
|
Serum Cytokine Levels
TNF alpha: Day 30
|
21.925 Picograms per millilitre (pg/mL)
Standard Deviation 7.509
|
21.200 Picograms per millilitre (pg/mL)
Standard Deviation 5.482
|
|
Serum Cytokine Levels
TNF alpha: Day 90
|
21.925 Picograms per millilitre (pg/mL)
Standard Deviation 6.879
|
21.040 Picograms per millilitre (pg/mL)
Standard Deviation 6.474
|
|
Serum Cytokine Levels
Soluble IL-2 receptor (SIL-2R) alpha: Day 0
|
116.500 Picograms per millilitre (pg/mL)
Standard Deviation 81.702
|
165.425 Picograms per millilitre (pg/mL)
Standard Deviation 78.977
|
|
Serum Cytokine Levels
sIL-2R alpha: Day 30
|
117.988 Picograms per millilitre (pg/mL)
Standard Deviation 93.112
|
108.060 Picograms per millilitre (pg/mL)
Standard Deviation 49.831
|
|
Serum Cytokine Levels
SIL-2R alpha: Day 90
|
72.325 Picograms per millilitre (pg/mL)
Standard Deviation 12.848
|
84.060 Picograms per millilitre (pg/mL)
Standard Deviation 48.465
|
SECONDARY outcome
Timeframe: Days 0 (pre-dose), 2, 30, and 90Population: Evaluable population for RSV included all participants who were positive for RSV at Study Day 0 as measured by RT-PCR. Participants with adequate nasal wash cytokine levels at specified time points were analyzed for this outcome.
Nasal wash cytokine levels are reported.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
n=5 Participants
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
|---|---|---|
|
Nasal Wash Cytokine Levels
IL-2: Day 90
|
8.000 pg/mL
Standard Deviation 0.000
|
8.000 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-4: Day 30
|
8.000 pg/mL
Standard Deviation 0.000
|
8.000 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-4: Day 90
|
36.120 pg/mL
Standard Deviation 29.029
|
8.000 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-5: Day 0
|
1.600 pg/mL
Standard Deviation 0.000
|
1.600 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-5: Day 2
|
1.600 pg/mL
Standard Deviation 0.000
|
1.600 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-5: Day30
|
1.600 pg/mL
Standard Deviation 0.000
|
1.600 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-5: Day 90
|
1.600 pg/mL
Standard Deviation 0.000
|
1.600 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-6: Day 0
|
172.480 pg/mL
Standard Deviation 327.548
|
411.320 pg/mL
Standard Deviation 477.909
|
|
Nasal Wash Cytokine Levels
IL-6: Day 2
|
42.950 pg/mL
Standard Deviation 28.197
|
278.467 pg/mL
Standard Deviation 231.477
|
|
Nasal Wash Cytokine Levels
IL-6: Day 30
|
3.300 pg/mL
Standard Deviation 3.801
|
19.440 pg/mL
Standard Deviation 21.978
|
|
Nasal Wash Cytokine Levels
IL-6: Day 90
|
6.540 pg/mL
Standard Deviation 7.079
|
7.300 pg/mL
Standard Deviation 6.300
|
|
Nasal Wash Cytokine Levels
IL-7: Day 0
|
15.220 pg/mL
Standard Deviation 7.083
|
19.480 pg/mL
Standard Deviation 12.696
|
|
Nasal Wash Cytokine Levels
IL-7: Day 2
|
15.700 pg/mL
Standard Deviation 8.895
|
30.567 pg/mL
Standard Deviation 10.058
|
|
Nasal Wash Cytokine Levels
IL-7: Day 30
|
8.000 pg/mL
Standard Deviation 0.000
|
8.000 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-7: Day 90
|
13.460 pg/mL
Standard Deviation 7.537
|
11.620 pg/mL
Standard Deviation 8.095
|
|
Nasal Wash Cytokine Levels
IL-8: Day 0
|
701.600 pg/mL
Standard Deviation 746.108
|
1488.540 pg/mL
Standard Deviation 791.215
|
|
Nasal Wash Cytokine Levels
IL-8: Day 2
|
1347.975 pg/mL
Standard Deviation 760.276
|
2000.000 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-8: Day 30
|
424.040 pg/mL
Standard Deviation 881.148
|
942.360 pg/mL
Standard Deviation 976.506
|
|
Nasal Wash Cytokine Levels
IL-8: Day 90
|
126.260 pg/mL
Standard Deviation 151.768
|
312.760 pg/mL
Standard Deviation 269.980
|
|
Nasal Wash Cytokine Levels
IL-9: Day 0
|
1.600 pg/mL
Standard Deviation 0.000
|
1.920 pg/mL
Standard Deviation 0.716
|
|
Nasal Wash Cytokine Levels
IL-9: Day 2
|
2.525 pg/mL
Standard Deviation 1.850
|
4.400 pg/mL
Standard Deviation 3.208
|
|
Nasal Wash Cytokine Levels
IL-9: Day 30
|
1.600 pg/mL
Standard Deviation 0.000
|
1.600 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-9: Day 90
|
1.600 pg/mL
Standard Deviation 0.000
|
1.600 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-10: Day 0
|
54.660 pg/mL
Standard Deviation 94.235
|
36.840 pg/mL
Standard Deviation 31.400
|
|
Nasal Wash Cytokine Levels
IL-10: Day 2
|
34.650 pg/mL
Standard Deviation 55.865
|
115.867 pg/mL
Standard Deviation 123.508
|
|
Nasal Wash Cytokine Levels
IL-10 Day 30
|
3.180 pg/mL
Standard Deviation 3.533
|
15.340 pg/mL
Standard Deviation 20.013
|
|
Nasal Wash Cytokine Levels
IL-10: Day 90
|
4.700 pg/mL
Standard Deviation 4.699
|
2.820 pg/mL
Standard Deviation 2.728
|
|
Nasal Wash Cytokine Levels
IL-11: Day 0
|
9.750 pg/mL
Standard Deviation 0.000
|
9.750 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-11: Day 2
|
9.750 pg/mL
Standard Deviation 0.000
|
9.750 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-11: Day 30
|
9.750 pg/mL
Standard Deviation 0.000
|
9.750 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-11: Day 90
|
9.750 pg/mL
Standard Deviation 0.000
|
9.750 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-12 P70: Day 0
|
11.380 pg/mL
Standard Deviation 7.558
|
10.240 pg/mL
Standard Deviation 5.009
|
|
Nasal Wash Cytokine Levels
IL-12 P70: Day 2
|
8.000 pg/mL
Standard Deviation 0.000
|
10.967 pg/mL
Standard Deviation 5.138
|
|
Nasal Wash Cytokine Levels
IL-12 P70: Day 30
|
8.000 pg/mL
Standard Deviation 0.000
|
8.000 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-12 P70: Day 90
|
8.000 pg/mL
Standard Deviation 0.000
|
8.000 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-13: Day 0
|
8.000 pg/mL
Standard Deviation 0.000
|
8.000 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-13: Day 2
|
8.000 pg/mL
Standard Deviation 0.000
|
11.033 pg/mL
Standard Deviation 5.254
|
|
Nasal Wash Cytokine Levels
IL-13: Day 30
|
8.000 pg/mL
Standard Deviation 0.000
|
8.000 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-13: Day 90
|
8.000 pg/mL
Standard Deviation 0.000
|
8.000 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-15: Day 0
|
2.900 pg/mL
Standard Deviation 2.907
|
6.580 pg/mL
Standard Deviation 4.089
|
|
Nasal Wash Cytokine Levels
IL-15: Day 2
|
3.275 pg/mL
Standard Deviation 2.311
|
7.900 pg/mL
Standard Deviation 1.418
|
|
Nasal Wash Cytokine Levels
IL-15: Day 30
|
1.600 pg/mL
Standard Deviation 0.000
|
2.580 pg/mL
Standard Deviation 1.470
|
|
Nasal Wash Cytokine Levels
IL-15: Day 90
|
1.960 pg/mL
Standard Deviation 0.805
|
2.300 pg/mL
Standard Deviation 1.565
|
|
Nasal Wash Cytokine Levels
IL-17: Day 0
|
2.640 pg/mL
Standard Deviation 2.326
|
3.060 pg/mL
Standard Deviation 2.024
|
|
Nasal Wash Cytokine Levels
IL-17: Day 2
|
2.475 pg/mL
Standard Deviation 1.750
|
2.900 pg/mL
Standard Deviation 2.252
|
|
Nasal Wash Cytokine Levels
IL-17: Day 30
|
1.600 pg/mL
Standard Deviation 0.000
|
1.600 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-17: Day 90
|
1.980 pg/mL
Standard Deviation 0.850
|
1.600 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
Eotaxin: Day 0
|
14.500 pg/mL
Standard Deviation 10.201
|
20.620 pg/mL
Standard Deviation 8.461
|
|
Nasal Wash Cytokine Levels
Eotaxin: Day 2
|
17.625 pg/mL
Standard Deviation 11.507
|
29.300 pg/mL
Standard Deviation 7.758
|
|
Nasal Wash Cytokine Levels
Eotaxin: Day 30
|
10.280 pg/mL
Standard Deviation 5.098
|
15.420 pg/mL
Standard Deviation 11.445
|
|
Nasal Wash Cytokine Levels
Eotaxin: Day 90
|
10.940 pg/mL
Standard Deviation 6.574
|
10.540 pg/mL
Standard Deviation 5.680
|
|
Nasal Wash Cytokine Levels
IFN gamma: Day 0
|
6.740 pg/mL
Standard Deviation 11.493
|
5.760 pg/mL
Standard Deviation 2.788
|
|
Nasal Wash Cytokine Levels
IFN gamma: Day 2
|
4.750 pg/mL
Standard Deviation 5.170
|
9.433 pg/mL
Standard Deviation 4.140
|
|
Nasal Wash Cytokine Levels
IFN gamma: Day 30
|
1.600 pg/mL
Standard Deviation 0.000
|
1.600 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IFN gamma: Day 90
|
1.940 pg/mL
Standard Deviation 0.760
|
2.080 pg/mL
Standard Deviation 1.073
|
|
Nasal Wash Cytokine Levels
IFN alpha 2: Day 0
|
11.580 pg/mL
Standard Deviation 8.005
|
16.900 pg/mL
Standard Deviation 8.306
|
|
Nasal Wash Cytokine Levels
IFN alpha 2: Day 2
|
12.075 pg/mL
Standard Deviation 8.150
|
19.800 pg/mL
Standard Deviation 11.377
|
|
Nasal Wash Cytokine Levels
IFN alpha 2: Day 30
|
8.000 pg/mL
Standard Deviation 0.000
|
8.000 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IFN alpha 2: Day 90
|
11.480 pg/mL
Standard Deviation 4.774
|
11.220 pg/mL
Standard Deviation 7.200
|
|
Nasal Wash Cytokine Levels
IP-10: Day 0
|
3030.820 pg/mL
Standard Deviation 3653.453
|
5850.060 pg/mL
Standard Deviation 4510.860
|
|
Nasal Wash Cytokine Levels
IP-10: Day 2
|
2699.550 pg/mL
Standard Deviation 3369.371
|
4405.733 pg/mL
Standard Deviation 4604.409
|
|
Nasal Wash Cytokine Levels
IP-10: Day 30
|
40.000 pg/mL
Standard Deviation 0.000
|
1378.140 pg/mL
Standard Deviation 1435.513
|
|
Nasal Wash Cytokine Levels
IP-10: Day 90
|
148.980 pg/mL
Standard Deviation 90.285
|
344.720 pg/mL
Standard Deviation 201.758
|
|
Nasal Wash Cytokine Levels
MCP-1: Day 0
|
138.280 pg/mL
Standard Deviation 261.810
|
352.860 pg/mL
Standard Deviation 400.479
|
|
Nasal Wash Cytokine Levels
MCP-1: Day 2
|
67.950 pg/mL
Standard Deviation 72.134
|
204.000 pg/mL
Standard Deviation 239.883
|
|
Nasal Wash Cytokine Levels
MCP-1: Day 30
|
15.160 pg/mL
Standard Deviation 16.010
|
75.900 pg/mL
Standard Deviation 69.833
|
|
Nasal Wash Cytokine Levels
MCP-1: Day 90
|
13.580 pg/mL
Standard Deviation 7.651
|
30.580 pg/mL
Standard Deviation 21.161
|
|
Nasal Wash Cytokine Levels
MIP-1 alpha: Day 0
|
229.060 pg/mL
Standard Deviation 463.273
|
116.280 pg/mL
Standard Deviation 109.432
|
|
Nasal Wash Cytokine Levels
MIP-1 alpha: Day 2
|
96.875 pg/mL
Standard Deviation 102.773
|
63.300 pg/mL
Standard Deviation 57.022
|
|
Nasal Wash Cytokine Levels
MIP-1 alpha: Day 30
|
34.720 pg/mL
Standard Deviation 59.748
|
83.880 pg/mL
Standard Deviation 118.987
|
|
Nasal Wash Cytokine Levels
MIP-1 alpha: Day 90
|
15.420 pg/mL
Standard Deviation 16.592
|
8.000 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
MIP-1 beta: Day 0
|
113.840 pg/mL
Standard Deviation 211.563
|
88.340 pg/mL
Standard Deviation 91.090
|
|
Nasal Wash Cytokine Levels
MIP-1 beta: Day 2
|
74.850 pg/mL
Standard Deviation 53.517
|
54.467 pg/mL
Standard Deviation 30.928
|
|
Nasal Wash Cytokine Levels
MIP-1 beta: Day 30
|
18.480 pg/mL
Standard Deviation 23.434
|
47.700 pg/mL
Standard Deviation 71.854
|
|
Nasal Wash Cytokine Levels
MIP-1 beta: Day 90
|
14.560 pg/mL
Standard Deviation 14.669
|
10.480 pg/mL
Standard Deviation 5.545
|
|
Nasal Wash Cytokine Levels
Rantes: Day 0
|
197.860 pg/mL
Standard Deviation 404.890
|
56.720 pg/mL
Standard Deviation 72.686
|
|
Nasal Wash Cytokine Levels
Rantes: Day 2
|
23.400 pg/mL
Standard Deviation 15.609
|
90.067 pg/mL
Standard Deviation 116.383
|
|
Nasal Wash Cytokine Levels
Rantes: Day 30
|
1.600 pg/mL
Standard Deviation 0.000
|
60.560 pg/mL
Standard Deviation 97.653
|
|
Nasal Wash Cytokine Levels
Rantes: Day 90
|
4.260 pg/mL
Standard Deviation 3.717
|
5.140 pg/mL
Standard Deviation 5.594
|
|
Nasal Wash Cytokine Levels
TNF alpha: Day 0
|
104.180 pg/mL
Standard Deviation 222.984
|
133.220 pg/mL
Standard Deviation 122.334
|
|
Nasal Wash Cytokine Levels
TNF alpha: Day 2
|
29.425 pg/mL
Standard Deviation 30.522
|
44.133 pg/mL
Standard Deviation 34.563
|
|
Nasal Wash Cytokine Levels
TNF alpha: Day 30
|
3.440 pg/mL
Standard Deviation 4.114
|
22.340 pg/mL
Standard Deviation 32.064
|
|
Nasal Wash Cytokine Levels
TNF alpha: Day 90
|
3.980 pg/mL
Standard Deviation 5.322
|
2.020 pg/mL
Standard Deviation 0.939
|
|
Nasal Wash Cytokine Levels
SIL-2R alpha: Day 0
|
10.500 pg/mL
Standard Deviation 5.590
|
14.580 pg/mL
Standard Deviation 9.265
|
|
Nasal Wash Cytokine Levels
SIL-2R alpha: Day 2
|
10.000 pg/mL
Standard Deviation 4.000
|
13.167 pg/mL
Standard Deviation 8.949
|
|
Nasal Wash Cytokine Levels
SIL-2R alpha: Day 30
|
8.000 pg/mL
Standard Deviation 0.000
|
8.000 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
SIL-2R alpha: Day 90
|
8.000 pg/mL
Standard Deviation 0.000
|
8.000 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-1 beta: Day 0
|
79.380 pg/mL
Standard Deviation 164.902
|
282.380 pg/mL
Standard Deviation 355.694
|
|
Nasal Wash Cytokine Levels
IL-1 beta: Day 2
|
94.050 pg/mL
Standard Deviation 123.565
|
144.367 pg/mL
Standard Deviation 113.883
|
|
Nasal Wash Cytokine Levels
IL-1 beta: Day 30
|
10.520 pg/mL
Standard Deviation 19.946
|
156.240 pg/mL
Standard Deviation 336.673
|
|
Nasal Wash Cytokine Levels
IL-1 beta: Day 90
|
4.300 pg/mL
Standard Deviation 4.391
|
2.680 pg/mL
Standard Deviation 2.415
|
|
Nasal Wash Cytokine Levels
IL-1 RA: Day 0
|
79.200 pg/mL
Standard Deviation 88.851
|
205.040 pg/mL
Standard Deviation 249.143
|
|
Nasal Wash Cytokine Levels
IL-1 RA: Day 2
|
69.225 pg/mL
Standard Deviation 50.434
|
255.533 pg/mL
Standard Deviation 184.664
|
|
Nasal Wash Cytokine Levels
IL-1 RA: Day 30
|
38.460 pg/mL
Standard Deviation 68.111
|
94.600 pg/mL
Standard Deviation 123.754
|
|
Nasal Wash Cytokine Levels
IL-1 RA: Day 90
|
24.100 pg/mL
Standard Deviation 22.976
|
39.240 pg/mL
Standard Deviation 30.922
|
|
Nasal Wash Cytokine Levels
IL-2: Day 0
|
8.000 pg/mL
Standard Deviation 0.000
|
8.000 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-2: Day 2
|
8.000 pg/mL
Standard Deviation 0.000
|
8.000 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-2: Day 30
|
8.000 pg/mL
Standard Deviation 0.000
|
8.000 pg/mL
Standard Deviation 0.000
|
|
Nasal Wash Cytokine Levels
IL-4: Day 0
|
25.820 pg/mL
Standard Deviation 34.379
|
14.160 pg/mL
Standard Deviation 13.774
|
|
Nasal Wash Cytokine Levels
IL-4: Day 2
|
8.000 pg/mL
Standard Deviation 0.000
|
22.300 pg/mL
Standard Deviation 17.419
|
SECONDARY outcome
Timeframe: From the administration of study drug (Day 0) through Day 90Population: Safety population included all participants who had received any study drug and had any follow-up.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
n=7 Participants
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs
|
5 Participants
|
6 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TESAEs
|
2 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Motavizumab 30 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=5 participants at risk
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
n=7 participants at risk
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
|---|---|---|
|
Infections and infestations
Gastroenteritis
|
20.0%
1/5 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
0.00%
0/7 • From the administration of study drug (Day 0) through Day 90
|
|
Metabolism and nutrition disorders
Failure to thrive
|
20.0%
1/5 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
0.00%
0/7 • From the administration of study drug (Day 0) through Day 90
|
Other adverse events
| Measure |
Placebo
n=5 participants at risk
Participants received a single intramuscular (IM) dose of placebo matched to motavizumab on Day 0 of the study.
|
Motavizumab 30 mg
n=7 participants at risk
Participants received a single IM dose of 30 milligrams/kilograms (mg/kg) of motavizumab on Day 0 of the study.
|
|---|---|---|
|
Eye disorders
Conjunctivitis
|
60.0%
3/5 • Number of events 3 • From the administration of study drug (Day 0) through Day 90
|
0.00%
0/7 • From the administration of study drug (Day 0) through Day 90
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
0.00%
0/7 • From the administration of study drug (Day 0) through Day 90
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
0.00%
0/7 • From the administration of study drug (Day 0) through Day 90
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
20.0%
1/5 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
0.00%
0/7 • From the administration of study drug (Day 0) through Day 90
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/5 • From the administration of study drug (Day 0) through Day 90
|
14.3%
1/7 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
|
Gastrointestinal disorders
Teething
|
20.0%
1/5 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
42.9%
3/7 • Number of events 3 • From the administration of study drug (Day 0) through Day 90
|
|
General disorders
Irritability
|
20.0%
1/5 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
0.00%
0/7 • From the administration of study drug (Day 0) through Day 90
|
|
General disorders
Pyrexia
|
40.0%
2/5 • Number of events 2 • From the administration of study drug (Day 0) through Day 90
|
14.3%
1/7 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/5 • From the administration of study drug (Day 0) through Day 90
|
14.3%
1/7 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
|
Infections and infestations
Bronchitis
|
20.0%
1/5 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
0.00%
0/7 • From the administration of study drug (Day 0) through Day 90
|
|
Infections and infestations
Candidiasis
|
20.0%
1/5 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
0.00%
0/7 • From the administration of study drug (Day 0) through Day 90
|
|
Infections and infestations
Gastroenteritis
|
20.0%
1/5 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
0.00%
0/7 • From the administration of study drug (Day 0) through Day 90
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
1/5 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
0.00%
0/7 • From the administration of study drug (Day 0) through Day 90
|
|
Infections and infestations
Otitis media
|
60.0%
3/5 • Number of events 4 • From the administration of study drug (Day 0) through Day 90
|
42.9%
3/7 • Number of events 3 • From the administration of study drug (Day 0) through Day 90
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/5 • From the administration of study drug (Day 0) through Day 90
|
14.3%
1/7 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
|
Infections and infestations
Rhinitis
|
20.0%
1/5 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
14.3%
1/7 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
|
Infections and infestations
Upper respiratory tract infection
|
40.0%
2/5 • Number of events 2 • From the administration of study drug (Day 0) through Day 90
|
28.6%
2/7 • Number of events 2 • From the administration of study drug (Day 0) through Day 90
|
|
Infections and infestations
Viral skin infection
|
20.0%
1/5 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
0.00%
0/7 • From the administration of study drug (Day 0) through Day 90
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/5 • From the administration of study drug (Day 0) through Day 90
|
14.3%
1/7 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/5 • From the administration of study drug (Day 0) through Day 90
|
14.3%
1/7 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
|
Metabolism and nutrition disorders
Feeding disorder of infancy or early childhood
|
20.0%
1/5 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
0.00%
0/7 • From the administration of study drug (Day 0) through Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
20.0%
1/5 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
0.00%
0/7 • From the administration of study drug (Day 0) through Day 90
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/5 • From the administration of study drug (Day 0) through Day 90
|
14.3%
1/7 • Number of events 2 • From the administration of study drug (Day 0) through Day 90
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
20.0%
1/5 • Number of events 2 • From the administration of study drug (Day 0) through Day 90
|
28.6%
2/7 • Number of events 2 • From the administration of study drug (Day 0) through Day 90
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.00%
0/5 • From the administration of study drug (Day 0) through Day 90
|
14.3%
1/7 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • From the administration of study drug (Day 0) through Day 90
|
14.3%
1/7 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
20.0%
1/5 • Number of events 1 • From the administration of study drug (Day 0) through Day 90
|
0.00%
0/7 • From the administration of study drug (Day 0) through Day 90
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical study Information Center
Phone: 1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER