Trial Outcomes & Findings for Persistence of Oral Tolerance to Peanut (NCT NCT01366846)
NCT ID: NCT01366846
Last Updated: 2017-03-10
Results Overview
At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose). Participants were considered to not have peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
556 participants
Primary outcome timeframe
72 months
Results posted on
2017-03-10
Participant Flow
From among those who completed the LEAP study (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), 556 subjects were recruited between 26 May 2011 and 6 June 2014 at Evelina Children's Hospital in London, UK.
In the LEAP trial, participants were stratified into strata based on a peanut allergen skin prick test (SPT). Participants were either SPT negative (0mm wheal) or SPT positive (1-4 mm wheal). Participants were then randomized into treatment groups within each stratum. This configuration was preserved in LEAP-On (this trial)
Participant milestones
| Measure |
Negative Stratum - Continued Peanut Avoidance Group
Participants who had a negative response to a peanut allergen skin prick test (no measurable wheal) and were then randomized into the peanut avoidance group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial)
|
Negative Stratum - Peanut Avoidance After Consumption Group
Participants who had a negative response to a peanut allergen skin prick test (no measurable wheal) and were then randomized into the peanut consumption group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial).
|
Positive Stratum - Continued Peanut Avoidance Group
Participants who had a positive response to a peanut allergen skin prick test (a wheal measuring between 1 and 4 mm) and were then randomized into the peanut avoidance group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial).
|
Positive Stratum - Peanut Avoidance After Peanut Consumption G
Participants who had a positive response to a peanut allergen skin prick test (a wheal measuring between 1 and 4 mm) and were then randomized into the peanut consumption group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
235
|
228
|
47
|
46
|
|
Overall Study
COMPLETED
|
232
|
224
|
46
|
45
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
1
|
1
|
Reasons for withdrawal
| Measure |
Negative Stratum - Continued Peanut Avoidance Group
Participants who had a negative response to a peanut allergen skin prick test (no measurable wheal) and were then randomized into the peanut avoidance group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial)
|
Negative Stratum - Peanut Avoidance After Consumption Group
Participants who had a negative response to a peanut allergen skin prick test (no measurable wheal) and were then randomized into the peanut consumption group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial).
|
Positive Stratum - Continued Peanut Avoidance Group
Participants who had a positive response to a peanut allergen skin prick test (a wheal measuring between 1 and 4 mm) and were then randomized into the peanut avoidance group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial).
|
Positive Stratum - Peanut Avoidance After Peanut Consumption G
Participants who had a positive response to a peanut allergen skin prick test (a wheal measuring between 1 and 4 mm) and were then randomized into the peanut consumption group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial).
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
|
Overall Study
Communication Difficulties
|
1
|
4
|
0
|
1
|
|
Overall Study
Scheduling Conflicts
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Persistence of Oral Tolerance to Peanut
Baseline characteristics by cohort
| Measure |
Negative Stratum - Peanut Avoidance Group
n=235 Participants
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
|
Negative Stratum - Peanut Consumption Group
n=228 Participants
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
|
Positive Stratum - Peanut Avoidance Group
n=47 Participants
Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
|
Positive Stratum - Peanut Consumption Group
n=46 Participants
Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
|
Total
n=556 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age in Months
|
61.0 Months
STANDARD_DEVIATION 3.44 • n=5 Participants
|
61.7 Months
STANDARD_DEVIATION 4.19 • n=7 Participants
|
60.6 Months
STANDARD_DEVIATION 3.76 • n=5 Participants
|
61.4 Months
STANDARD_DEVIATION 4.98 • n=4 Participants
|
61.3 Months
STANDARD_DEVIATION 3.93 • n=21 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
219 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
150 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
337 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
235 participants
n=5 Participants
|
228 participants
n=7 Participants
|
47 participants
n=5 Participants
|
46 participants
n=4 Participants
|
556 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 72 monthsPopulation: Intent-to-treat with available data at 72 months
At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose). Participants were considered to not have peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.
Outcome measures
| Measure |
Negative Stratum - Peanut Avoidance Group
n=234 Participants
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
|
Negative Stratum - Peanut Consumption Group
n=224 Participants
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
|
Positive Stratum - Peanut Avoidance Group
n=46 Participants
Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
|
Positive Stratum - Peanut Consumption Group
n=46 Participants
Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
|
|---|---|---|---|---|
|
Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum
|
34 Participants
|
7 Participants
|
18 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 72 monthsPopulation: Intent-to-treat with available data at 72 Months
At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.
Outcome measures
| Measure |
Negative Stratum - Peanut Avoidance Group
n=280 Participants
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
|
Negative Stratum - Peanut Consumption Group
n=270 Participants
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
|
Positive Stratum - Peanut Avoidance Group
Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
|
Positive Stratum - Peanut Consumption Group
Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
|
|---|---|---|---|---|
|
Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group
|
52 Participants
|
13 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 72 monthsPopulation: Per Protocol
At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.
Outcome measures
| Measure |
Negative Stratum - Peanut Avoidance Group
n=226 Participants
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
|
Negative Stratum - Peanut Consumption Group
n=171 Participants
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
|
Positive Stratum - Peanut Avoidance Group
n=46 Participants
Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
|
Positive Stratum - Peanut Consumption Group
n=36 Participants
Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
|
|---|---|---|---|---|
|
Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum in the Per Protocol Population
|
34 Participants
|
7 Participants
|
18 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 72 monthsPopulation: Per Protocol
At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.
Outcome measures
| Measure |
Negative Stratum - Peanut Avoidance Group
n=272 Participants
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
|
Negative Stratum - Peanut Consumption Group
n=207 Participants
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
|
Positive Stratum - Peanut Avoidance Group
Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
|
Positive Stratum - Peanut Consumption Group
Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
|
|---|---|---|---|---|
|
Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group in the Per Protocol Population
|
52 Participants
|
13 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 60 months and 72 monthsPopulation: Intent-to-treat
At 60 and 72 months of age, eligible participants were given an oral food challenge (intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 9.4g/13.7g (month 60/month 72) of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.
Outcome measures
| Measure |
Negative Stratum - Peanut Avoidance Group
n=270 Participants
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
|
Negative Stratum - Peanut Consumption Group
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
|
Positive Stratum - Peanut Avoidance Group
Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
|
Positive Stratum - Peanut Consumption Group
Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
|
|---|---|---|---|---|
|
Number of Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within the Peanut Avoidance After Peanut Consumption Group
Month 60
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within the Peanut Avoidance After Peanut Consumption Group
Month 72
|
13 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 60 months and 72 monthsPopulation: Per Protocol
At 60 and 72 months of age, eligible participants were given an oral food challenge (intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 9.4g/13.7g (month 60/month 72) of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.
Outcome measures
| Measure |
Negative Stratum - Peanut Avoidance Group
n=207 Participants
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
|
Negative Stratum - Peanut Consumption Group
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
|
Positive Stratum - Peanut Avoidance Group
Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
|
Positive Stratum - Peanut Consumption Group
Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
|
|---|---|---|---|---|
|
Number of Peanut Avoidance After Peanut Consumption Group Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within in the Per Protocol Population
Month 60
|
10 Participants
|
—
|
—
|
—
|
|
Number of Peanut Avoidance After Peanut Consumption Group Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within in the Per Protocol Population
Month 72
|
13 Participants
|
—
|
—
|
—
|
Adverse Events
Negative Stratum - Peanut Avoidance Group
Serious events: 12 serious events
Other events: 206 other events
Deaths: 0 deaths
Negative Stratum - Peanut Consumption Group
Serious events: 7 serious events
Other events: 182 other events
Deaths: 0 deaths
Positive Stratum - Peanut Avoidance Group
Serious events: 3 serious events
Other events: 45 other events
Deaths: 0 deaths
Positive Stratum - Peanut Consumption Group
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Negative Stratum - Peanut Avoidance Group
n=235 participants at risk
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
|
Negative Stratum - Peanut Consumption Group
n=228 participants at risk
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
|
Positive Stratum - Peanut Avoidance Group
n=47 participants at risk
Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
|
Positive Stratum - Peanut Consumption Group
n=46 participants at risk
Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
|
|---|---|---|---|---|
|
Immune system disorders
Anaphylactic reaction
|
0.85%
2/235 • Number of events 3 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.44%
1/228 • Number of events 1 • 4 years, 3 months
During active follow-up study ITN049AD
|
4.3%
2/47 • Number of events 2 • 4 years, 3 months
During active follow-up study ITN049AD
|
4.3%
2/46 • Number of events 2 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Infections and infestations
Abscess limb
|
0.43%
1/235 • Number of events 1 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/228 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/47 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/46 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Infections and infestations
Eczema infected
|
0.43%
1/235 • Number of events 1 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/228 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/47 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/46 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Infections and infestations
Pneumonia viral
|
0.43%
1/235 • Number of events 1 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/228 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/47 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/46 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/235 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.44%
1/228 • Number of events 1 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/47 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/46 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.43%
1/235 • Number of events 1 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/228 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/47 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/46 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/235 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.44%
1/228 • Number of events 1 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/47 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/46 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/235 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.44%
1/228 • Number of events 1 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/47 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/46 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/235 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.44%
1/228 • Number of events 1 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/47 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/46 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Nervous system disorders
Convulsion
|
0.43%
1/235 • Number of events 1 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/228 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/47 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/46 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.85%
2/235 • Number of events 3 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.88%
2/228 • Number of events 2 • 4 years, 3 months
During active follow-up study ITN049AD
|
2.1%
1/47 • Number of events 1 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/46 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.3%
3/235 • Number of events 3 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/228 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/47 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/46 • 4 years, 3 months
During active follow-up study ITN049AD
|
Other adverse events
| Measure |
Negative Stratum - Peanut Avoidance Group
n=235 participants at risk
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
|
Negative Stratum - Peanut Consumption Group
n=228 participants at risk
Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
|
Positive Stratum - Peanut Avoidance Group
n=47 participants at risk
Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
|
Positive Stratum - Peanut Consumption Group
n=46 participants at risk
Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
7/235 • Number of events 9 • 4 years, 3 months
During active follow-up study ITN049AD
|
2.2%
5/228 • Number of events 5 • 4 years, 3 months
During active follow-up study ITN049AD
|
6.4%
3/47 • Number of events 3 • 4 years, 3 months
During active follow-up study ITN049AD
|
4.3%
2/46 • Number of events 2 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
12/235 • Number of events 13 • 4 years, 3 months
During active follow-up study ITN049AD
|
6.6%
15/228 • Number of events 18 • 4 years, 3 months
During active follow-up study ITN049AD
|
8.5%
4/47 • Number of events 5 • 4 years, 3 months
During active follow-up study ITN049AD
|
8.7%
4/46 • Number of events 4 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
General disorders
Pyrexia
|
5.5%
13/235 • Number of events 14 • 4 years, 3 months
During active follow-up study ITN049AD
|
5.3%
12/228 • Number of events 12 • 4 years, 3 months
During active follow-up study ITN049AD
|
6.4%
3/47 • Number of events 3 • 4 years, 3 months
During active follow-up study ITN049AD
|
6.5%
3/46 • Number of events 3 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Immune system disorders
Food allergy
|
17.9%
42/235 • Number of events 57 • 4 years, 3 months
During active follow-up study ITN049AD
|
11.4%
26/228 • Number of events 42 • 4 years, 3 months
During active follow-up study ITN049AD
|
34.0%
16/47 • Number of events 20 • 4 years, 3 months
During active follow-up study ITN049AD
|
28.3%
13/46 • Number of events 19 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Immune system disorders
Seasonal allergy
|
5.1%
12/235 • Number of events 13 • 4 years, 3 months
During active follow-up study ITN049AD
|
2.2%
5/228 • Number of events 6 • 4 years, 3 months
During active follow-up study ITN049AD
|
4.3%
2/47 • Number of events 2 • 4 years, 3 months
During active follow-up study ITN049AD
|
4.3%
2/46 • Number of events 2 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Infections and infestations
Ear infection
|
3.4%
8/235 • Number of events 9 • 4 years, 3 months
During active follow-up study ITN049AD
|
3.9%
9/228 • Number of events 12 • 4 years, 3 months
During active follow-up study ITN049AD
|
8.5%
4/47 • Number of events 4 • 4 years, 3 months
During active follow-up study ITN049AD
|
4.3%
2/46 • Number of events 2 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Infections and infestations
Gastroenteritis
|
9.8%
23/235 • Number of events 26 • 4 years, 3 months
During active follow-up study ITN049AD
|
5.3%
12/228 • Number of events 12 • 4 years, 3 months
During active follow-up study ITN049AD
|
8.5%
4/47 • Number of events 4 • 4 years, 3 months
During active follow-up study ITN049AD
|
8.7%
4/46 • Number of events 4 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Infections and infestations
Lower respiratory tract infection
|
8.5%
20/235 • Number of events 22 • 4 years, 3 months
During active follow-up study ITN049AD
|
3.1%
7/228 • Number of events 8 • 4 years, 3 months
During active follow-up study ITN049AD
|
4.3%
2/47 • Number of events 4 • 4 years, 3 months
During active follow-up study ITN049AD
|
10.9%
5/46 • Number of events 5 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Infections and infestations
Respiratory tract infection
|
17.0%
40/235 • Number of events 54 • 4 years, 3 months
During active follow-up study ITN049AD
|
17.1%
39/228 • Number of events 47 • 4 years, 3 months
During active follow-up study ITN049AD
|
23.4%
11/47 • Number of events 13 • 4 years, 3 months
During active follow-up study ITN049AD
|
19.6%
9/46 • Number of events 11 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Infections and infestations
Rhinitis
|
19.6%
46/235 • Number of events 52 • 4 years, 3 months
During active follow-up study ITN049AD
|
18.0%
41/228 • Number of events 44 • 4 years, 3 months
During active follow-up study ITN049AD
|
19.1%
9/47 • Number of events 12 • 4 years, 3 months
During active follow-up study ITN049AD
|
17.4%
8/46 • Number of events 10 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Infections and infestations
Varicella
|
4.7%
11/235 • Number of events 11 • 4 years, 3 months
During active follow-up study ITN049AD
|
7.0%
16/228 • Number of events 16 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/47 • 4 years, 3 months
During active follow-up study ITN049AD
|
8.7%
4/46 • Number of events 4 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Infections and infestations
Viral infection
|
5.5%
13/235 • Number of events 15 • 4 years, 3 months
During active follow-up study ITN049AD
|
4.8%
11/228 • Number of events 11 • 4 years, 3 months
During active follow-up study ITN049AD
|
2.1%
1/47 • Number of events 1 • 4 years, 3 months
During active follow-up study ITN049AD
|
2.2%
1/46 • Number of events 1 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Injury, poisoning and procedural complications
Head injury
|
1.3%
3/235 • Number of events 4 • 4 years, 3 months
During active follow-up study ITN049AD
|
1.3%
3/228 • Number of events 3 • 4 years, 3 months
During active follow-up study ITN049AD
|
6.4%
3/47 • Number of events 4 • 4 years, 3 months
During active follow-up study ITN049AD
|
0.00%
0/46 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
13.6%
32/235 • Number of events 41 • 4 years, 3 months
During active follow-up study ITN049AD
|
8.8%
20/228 • Number of events 34 • 4 years, 3 months
During active follow-up study ITN049AD
|
8.5%
4/47 • Number of events 5 • 4 years, 3 months
During active follow-up study ITN049AD
|
15.2%
7/46 • Number of events 14 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.8%
16/235 • Number of events 18 • 4 years, 3 months
During active follow-up study ITN049AD
|
6.1%
14/228 • Number of events 21 • 4 years, 3 months
During active follow-up study ITN049AD
|
6.4%
3/47 • Number of events 4 • 4 years, 3 months
During active follow-up study ITN049AD
|
10.9%
5/46 • Number of events 5 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.7%
18/235 • Number of events 21 • 4 years, 3 months
During active follow-up study ITN049AD
|
8.3%
19/228 • Number of events 21 • 4 years, 3 months
During active follow-up study ITN049AD
|
17.0%
8/47 • Number of events 13 • 4 years, 3 months
During active follow-up study ITN049AD
|
6.5%
3/46 • Number of events 3 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Skin and subcutaneous tissue disorders
Eczema
|
26.0%
61/235 • Number of events 79 • 4 years, 3 months
During active follow-up study ITN049AD
|
18.4%
42/228 • Number of events 56 • 4 years, 3 months
During active follow-up study ITN049AD
|
29.8%
14/47 • Number of events 15 • 4 years, 3 months
During active follow-up study ITN049AD
|
19.6%
9/46 • Number of events 9 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
10/235 • Number of events 10 • 4 years, 3 months
During active follow-up study ITN049AD
|
4.4%
10/228 • Number of events 10 • 4 years, 3 months
During active follow-up study ITN049AD
|
4.3%
2/47 • Number of events 2 • 4 years, 3 months
During active follow-up study ITN049AD
|
6.5%
3/46 • Number of events 4 • 4 years, 3 months
During active follow-up study ITN049AD
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.1%
5/235 • Number of events 5 • 4 years, 3 months
During active follow-up study ITN049AD
|
5.7%
13/228 • Number of events 15 • 4 years, 3 months
During active follow-up study ITN049AD
|
10.6%
5/47 • Number of events 5 • 4 years, 3 months
During active follow-up study ITN049AD
|
4.3%
2/46 • Number of events 3 • 4 years, 3 months
During active follow-up study ITN049AD
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place