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A Randomized, Double-Blind Placebo-Controlled Peanut Sublingual Immunotherapy Trial

This study has been completed.
Sponsor:
Collaborator:
Consortium of Food Allergy Research
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00580606
First received: December 18, 2007
Last updated: December 15, 2015
Last verified: December 2015
Results First Received: September 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Food Hypersensitivity
Hypersensitivity
Immediate Hypersensitivity
Peanut Hypersensitivity
Interventions: Drug: Glycerinated peanut allergenic extract
Drug: Placebo for peanut extract (glycerin)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment took place at five university-based medical centers in the United States (Mt. Sinai School of Medicine, Johns Hopkins University, Duke University, National Jewish Medical Center, University of Arkansas Children's Hospital from April 2008 to January 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Low Dose Peanut SLIT (Double Blind to Open Label) Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL) Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.

Participant Flow for 2 periods

Period 1:   Double Blind (DB)
    Low Dose Peanut SLIT (Double Blind to Open Label)   Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)
STARTED   20   20 
Had Week 44 Oral Food Challenge   18   19 
COMPLETED   20 [1]   20 [1] 
NOT COMPLETED   0   0 
[1] Completed: Participants who were assessed for the primary outcome measure.

Period 2:   Open Label (OL)
    Low Dose Peanut SLIT (Double Blind to Open Label)   Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)
STARTED   18 [1]   17 [2] 
Had Week 44 Oral Food Challenge   0 [3]   12 [4] 
Had Week 68 Oral Food Challenge   15   12 
Had Week 116 Oral Food Challenge   13   6 
Had Week 164 Oral Food Challenge   9   5 
Had Week 172 Oral Food Challenge   2   2 
COMPLETED   9 [5]   5 [5] 
NOT COMPLETED   9   12 
Lack of Efficacy at Week 116 OFC                2                1 
Withdrawal by Subject                4                6 
Dosing Symptoms                0                1 
Lost to Follow-up                0                1 
Pregnancy                0                1 
Non-compliance                2                0 
Physician Decision                1                1 
Needed Prohibited Medication                0                1 
[1] 2 participants discontinued dosing before Open Label (OL) period.
[2] 1 participant discontinued dosing before OL period; 2 passed Week 44 OFC & ineligible to crossover.
[3] The Week 44 OFC for Low Dose Peanut SLIT was done at the end of the DB Period, not the OL period.
[4] After 44 weeks of OL high dose SLIT; 1 additional participant declined Week 44 OFC in OL period.
[5] Completed dosing & final Wk 164 desensitization OFC & Wk 172 tolerance OFC (if passed Wk 164 OFC).



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Low Dose Peanut SLIT (Double Blind to Open Label) Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL) Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
Total Total of all reporting groups

Baseline Measures
   Low Dose Peanut SLIT (Double Blind to Open Label)   Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   40 
Age 
[Units: Participants]
     
<=18 years   15   15   30 
Between 18 and 65 years   5   5   10 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 17.2  (7.6)   16.5  (3.5)   16.8  (5.8) 
Gender 
[Units: Participants]
     
Female   7   6   13 
Male   13   14   27 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   0   0   0 
Not Hispanic or Latino   20   20   40 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   2   1   3 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   1   0   1 
White   17   19   36 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   20   20   40 
Atopic Dermatitis Total Score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 1.1  (1.7)   0.9  (1.6)   1.0  (1.6) 
[1] The Atopic Dermatitis Total Score is scored on a 10 point scale of 0 to 9 where a higher score indicates increasing severity of atopic dermatitis. This score is a combination of three scores that range from 0 to 3 in the following areas: body surface area score, disease course, and disease intensity.
Total IgE [1] 
[Units: kU/L]
Mean (Standard Deviation)
 407.8  (254.1)   330.5  (305.0)   369.1  (279.9) 
[1] Total amount of serum immunoglobulin E. Individuals who are not allergic may have a total IgE as high as 304 kU/L.
Peanut IgE [1] 
[Units: kUA/L]
Mean (Standard Deviation)
 33.6  (38.1)   47.1  (58.0)   40.4  (48.9) 
[1] Amount of serum peanut-specific immunoglobulin E. Individuals with a peanut IgE of <0.35 kUA/L are considered not to be sensitized to peanut.
Peanut Skin Prick Test Score [1] 
[Units: Mm]
Mean (Standard Deviation)
 14.0  (6.9)   12.4  (4.6)   13.2  (5.9) 
[1] This score is calculated by subtracting the size of the saline wheal (in mm) from the size of the peanut wheal (in mm) observed for a skin prick test. Individuals with a peanut skin prick test score of < 3 mm are considered to have a negative result. 1 subject in the Placebo group did not have a value for this measure.
Age at Initial Peanut Allergic Reaction [1] 
[Units: Years]
Mean (Standard Deviation)
 4.6  (6.9)   1.9  (1.5)   3.3  (5.2) 
[1] Two subjects in the Placebo group did not have a value for this measure.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent of Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge   [ Time Frame: Week 44 (Double Blind Period) ]

2.  Secondary:   Percent of Participants Who Achieved a Maintenance Dose of 1,386 mcg   [ Time Frame: Week 44 (Double Blind Period) ]

3.  Secondary:   Percent of Crossover Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge After 44 Weeks of Open Label Peanut Protein Consumption   [ Time Frame: Week 44 after initiating crossover open label peanut protein consumption ]

4.  Secondary:   Percent of Crossover Participants Who Achieved an Open Label Peanut Protein Consumption Maintenance Dose of 3,696 mcg   [ Time Frame: Week 44 after initiating crossover open label peanut protein consumption ]

5.  Secondary:   Number of Participants With Serious Adverse Events (SAEs)   [ Time Frame: Baseline through Week 44 (Double Blind Period) ]

6.  Secondary:   Number of Crossover Participants With Serious Adverse Events (SAEs) During 44 Weeks of Open Label Peanut Protein Consumption   [ Time Frame: Initiation of open label peanut protein study therapy through Week 44 of open label peanut protein consumption ]

7.  Secondary:   Percent of Participants Who Successfully Consumed 10,000 mg of Peanut Powder   [ Time Frame: Approximately 8 weeks after discontinuing study therapy after 3 years on maintenance study therapy ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame Baseline through 44 weeks of study therapy
Additional Description This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.

Frequency Threshold
Threshold above which other adverse events are reported   5  

Reporting Groups
  Description
Low Dose Peanut SLIT Before Week 44 OFC (Double Blind) Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy
Placebo Before Week 44 OFC (Double Blind) Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy
High Dose Peanut SLIT Crossover Before Wk44 Crossover OFC (OL) Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After 44 weeks of open label SLIT, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. SLIT=Sublingual Immunotherapy
Low Dose Peanut SLIT (Double Blind to Open Label) After completion of the 5,000 mg Oral Food Challenge (OFC) at Week 44, subjects/study staff are unblinded and subjects continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL) After 44 weeks of open label therapy, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. After completion of this Week 44 OFC, subjects then either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy

Other Adverse Events
    Low Dose Peanut SLIT Before Week 44 OFC (Double Blind)   Placebo Before Week 44 OFC (Double Blind)   High Dose Peanut SLIT Crossover Before Wk44 Crossover OFC (OL)   Low Dose Peanut SLIT (Double Blind to Open Label)   Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)
Total, other (not including serious) adverse events           
# participants affected / at risk   19/20 (95.00%)   20/20 (100.00%)   17/17 (100.00%)   17/18 (94.44%)   15/17 (88.24%) 
Cardiac disorders           
Tachycardia * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   0   0   0   1   0 
Ear and labyrinth disorders           
Ear pruritus † 1           
# participants affected / at risk   0/20 (0.00%)   1/20 (5.00%)   1/17 (5.88%)   0/18 (0.00%)   1/14 (7.14%) 
# events   0   1   114   0   4 
External ear inflammation * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   0/18 (0.00%)   1/17 (5.88%) 
# events   0   0   0   0   1 
Vertigo * 1           
# participants affected / at risk   1/20 (5.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   1   0   0   1   0 
Eye disorders           
Conjunctivitis * 1           
# participants affected / at risk   0/20 (0.00%)   1/20 (5.00%)   1/17 (5.88%)   0/18 (0.00%)   1/17 (5.88%) 
# events   0   1   1   0   1 
Conjunctivitis allergic * 1           
# participants affected / at risk   2/20 (10.00%)   1/20 (5.00%)   0/17 (0.00%)   0/18 (0.00%)   0/17 (0.00%) 
# events   2   1   0   0   0 
Eye pruritus * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   0   0   0   1   0 
Lacrimation increased † 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   0/18 (0.00%)   1/14 (7.14%) 
# events   0   0   0   0   5 
Photophobia * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   0   1   0   0 
Gastrointestinal disorders           
Abdominal discomfort † 1           
# participants affected / at risk   7/20 (35.00%)   1/20 (5.00%)   6/17 (35.29%)   2/18 (11.11%)   2/14 (14.29%) 
# events   53   1   33   7   16 
Abdominal pain * 1           
# participants affected / at risk   2/20 (10.00%)   0/20 (0.00%)   0/17 (0.00%)   0/18 (0.00%)   0/17 (0.00%) 
# events   3   0   0   0   0 
Abdominal pain † 1           
# participants affected / at risk   1/20 (5.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/14 (0.00%) 
# events   1   0   1   0   0 
Abdominal pain upper * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   2/17 (11.76%)   0/18 (0.00%)   1/17 (5.88%) 
# events   0   0   2   0   11 
Diarrhoea * 1           
# participants affected / at risk   0/20 (0.00%)   3/20 (15.00%)   0/17 (0.00%)   0/18 (0.00%)   1/17 (5.88%) 
# events   0   4   0   0   1 
Dyspepsia † 1           
# participants affected / at risk   2/20 (10.00%)   0/20 (0.00%)   0/17 (0.00%)   0/18 (0.00%)   0/14 (0.00%) 
# events   3   0   0   0   0 
Dysphagia * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   0   0   0   1   0 
Food Poisoning * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   0/18 (0.00%)   1/17 (5.88%) 
# events   0   0   0   0   1 
Mouth ulceration * 1           
# participants affected / at risk   0/20 (0.00%)   1/20 (5.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   1   1   0   0 
Nausea * 1           
# participants affected / at risk   1/20 (5.00%)   1/20 (5.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   1   1   0   1   0 
Nausea † 1           
# participants affected / at risk   2/20 (10.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   1/14 (7.14%) 
# events   10   0   1   0   1 
Oral disorder † 1           
# participants affected / at risk   17/20 (85.00%)   6/20 (30.00%)   16/17 (94.12%)   14/18 (77.78%)   8/14 (57.14%) 
# events   2171   23   1579   1913   1326 
Oral pain * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   0   1   0   0 
Swollen tongue † 1           
# participants affected / at risk   3/20 (15.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/14 (0.00%) 
# events   8   0   1   0   0 
Toothache * 1           
# participants affected / at risk   0/20 (0.00%)   2/20 (10.00%)   0/17 (0.00%)   0/18 (0.00%)   1/17 (5.88%) 
# events   0   2   0   0   2 
Vomiting * 1           
# participants affected / at risk   0/20 (0.00%)   2/20 (10.00%)   2/17 (11.76%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   2   2   0   0 
Vomiting † 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/14 (0.00%) 
# events   0   0   1   0   0 
General disorders           
Chills † 1           
# participants affected / at risk   1/20 (5.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   0/14 (0.00%) 
# events   2   0   0   2   0 
Feeling hot † 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/14 (0.00%) 
# events   0   0   1   0   0 
Influenza like illness * 1           
# participants affected / at risk   1/20 (5.00%)   1/20 (5.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   1   1   1   0   0 
Pain * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   0   1   0   0 
Pyrexia * 1           
# participants affected / at risk   1/20 (5.00%)   0/20 (0.00%)   1/17 (5.88%)   2/18 (11.11%)   1/17 (5.88%) 
# events   1   0   2   2   3 
Immune system disorders           
Allergy to animal * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   0   1   0   0 
Hypersensitivity * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   3/18 (16.67%)   0/17 (0.00%) 
# events   0   0   0   3   0 
Seasonal allergy * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   2/18 (11.11%)   1/17 (5.88%) 
# events   0   0   0   2   1 
Infections and infestations           
Bronchitis * 1           
# participants affected / at risk   1/20 (5.00%)   0/20 (0.00%)   2/17 (11.76%)   0/18 (0.00%)   2/17 (11.76%) 
# events   1   0   2   0   2 
Chronic sinusitis * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   0/18 (0.00%)   1/17 (5.88%) 
# events   0   0   0   0   1 
Cystitis * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   0/18 (0.00%)   1/17 (5.88%) 
# events   0   0   0   0   1 
Ear infection * 1           
# participants affected / at risk   2/20 (10.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   1/17 (5.88%) 
# events   3   0   0   1   1 
Gastroenteritis * 1           
# participants affected / at risk   0/20 (0.00%)   1/20 (5.00%)   1/17 (5.88%)   0/18 (0.00%)   2/17 (11.76%) 
# events   0   1   1   0   2 
Gastroenteritis viral * 1           
# participants affected / at risk   0/20 (0.00%)   1/20 (5.00%)   0/17 (0.00%)   0/18 (0.00%)   1/17 (5.88%) 
# events   0   1   0   0   1 
Gastrointestinal viral infection * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   0   1   0   0 
Infectious mononucleosis * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   0/18 (0.00%)   1/17 (5.88%) 
# events   0   0   0   0   1 
Influenza * 1           
# participants affected / at risk   1/20 (5.00%)   2/20 (10.00%)   2/17 (11.76%)   1/18 (5.56%)   0/17 (0.00%) 
# events   1   2   2   1   0 
Kidney infection * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   0/18 (0.00%)   1/17 (5.88%) 
# events   0   0   0   0   1 
Laryngitis * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   0   0   0   1   0 
Meningitis viral * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   0   1   0   0 
Nasopharyngitis * 1           
# participants affected / at risk   4/20 (20.00%)   5/20 (25.00%)   3/17 (17.65%)   3/18 (16.67%)   1/17 (5.88%) 
# events   6   7   7   4   1 
Otitis externa * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   1/17 (5.88%) 
# events   0   0   1   0   2 
Otitis media * 1           
# participants affected / at risk   1/20 (5.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   1/17 (5.88%) 
# events   1   0   1   0   1 
Pharyngitis streptococcal * 1           
# participants affected / at risk   1/20 (5.00%)   0/20 (0.00%)   0/17 (0.00%)   0/18 (0.00%)   1/17 (5.88%) 
# events   1   0   0   0   1 
Pneumonia * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   0   0   0   1   0 
Respiratory tract infection * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   0   1   0   0 
Sinusitis * 1           
# participants affected / at risk   4/20 (20.00%)   2/20 (10.00%)   3/17 (17.65%)   3/18 (16.67%)   4/17 (23.53%) 
# events   5   2   4   3   7 
Tinea pedis * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   0   0   0   1   0 
Upper respiratory tract infection * 1           
# participants affected / at risk   4/20 (20.00%)   4/20 (20.00%)   3/17 (17.65%)   3/18 (16.67%)   3/17 (17.65%) 
# events   5   8   6   10   8 
Urinary tract infection * 1           
# participants affected / at risk   0/20 (0.00%)   1/20 (5.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   0   1   0   1   0 
Viral infection * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   1/18 (5.56%)   1/17 (5.88%) 
# events   0   0   1   1   1 
Injury, poisoning and procedural complications           
Arthropod bite * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   0   1   0   0 
Cartilage injury * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   0   0   0   1   0 
Concussion * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   1/18 (5.56%)   0/17 (0.00%) 
# events   0   0   1   2   0 
Foot fracture * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   0   0   0   1   0 
Hand fracture * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   2/18 (11.11%)   1/17 (5.88%) 
# events   0   0   0   2   1 
Joint dislocation * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   1/17 (5.88%) 
# events   0   0   0   1   1 
Joint injury * 1           
# participants affected / at risk   1/20 (5.00%)   1/20 (5.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   1   1   0   1   0 
Laceration * 1           
# participants affected / at risk   0/20 (0.00%)   1/20 (5.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   0   1   0   1   0 
Ligament injury * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   0   1   0   0 
Ligament sprain * 1           
# participants affected / at risk   1/20 (5.00%)   3/20 (15.00%)   1/17 (5.88%)   0/18 (0.00%)   1/17 (5.88%) 
# events   1   3   1   0   1 
Lip injury * 1           
# participants affected / at risk   1/20 (5.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   1   0   0   1   0 
Lower limb fracture * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   0   1   0   0 
Pelvic fracture * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   0   1   0   0 
Road traffic accident * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   0   1   0   0 
Skin abrasion * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   0/18 (0.00%)   1/17 (5.88%) 
# events   0   0   0   0   1 
Sports injury * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   0   0   0   1   0 
Musculoskeletal and connective tissue disorders           
Arthralgia * 1           
# participants affected / at risk   0/20 (0.00%)   1/20 (5.00%)   0/17 (0.00%)   1/18 (5.56%)   1/17 (5.88%) 
# events   0   1   0   1   1 
Back pain * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   1/18 (5.56%)   1/17 (5.88%) 
# events   0   0   1   1   3 
Muscle spasms * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   0/18 (0.00%)   1/17 (5.88%) 
# events   0   0   0   0   2 
Muskuloskeletal pain * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   1/17 (5.88%) 
# events   0   0   0   1   1 
Myalgia * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   1/17 (5.88%) 
# events   0   0   0   3   1 
Neck pain * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   0   1   0   0 
Pain in extremity * 1           
# participants affected / at risk   1/20 (5.00%)   0/20 (0.00%)   0/17 (0.00%)   0/18 (0.00%)   1/17 (5.88%) 
# events   1   0   0   0   5 
Pain in jaw * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   0   1   0   0 
Tendonitis * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   0   1   0   0 
Nervous system disorders           
Dizziness † 1           
# participants affected / at risk   2/20 (10.00%)   0/20 (0.00%)   0/17 (0.00%)   0/18 (0.00%)   0/14 (0.00%) 
# events   4   0   0   0   0 
Headache * 1           
# participants affected / at risk   2/20 (10.00%)   3/20 (15.00%)   3/17 (17.65%)   2/18 (11.11%)   2/17 (11.76%) 
# events   4   5   6   6   20 
Hypoaesthesia * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   0   0   0   1   0 
Migraine * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   2/17 (11.76%) 
# events   0   0   0   1   2 
Sinus headache * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   1/17 (5.88%) 
# events   0   0   0   1   2 
Pregnancy, puerperium and perinatal conditions           
Pregnancy * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   0   1   0   0 
Psychiatric disorders           
Alcoholism * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   0   0   0   1   0 
Anxiety † 1           
# participants affected / at risk   0/20 (0.00%)   1/20 (5.00%)   0/17 (0.00%)   0/18 (0.00%)   1/14 (7.14%) 
# events   0   1   0   0   3 
Anxiety * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   2/18 (11.11%)   0/17 (0.00%) 
# events   0   0   0   2   0 
Depression * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   0   0   0   1   0 
Reproductive system and breast disorders           
Dysmenorrhoea * 1           
# participants affected / at risk   1/20 (5.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   1/17 (5.88%) 
# events   3   0   1   0   2 
Ovarian cyst * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   0   0   0   1   0 
Respiratory, thoracic and mediastinal disorders           
Asthma * 1           
# participants affected / at risk   0/20 (0.00%)   2/20 (10.00%)   2/17 (11.76%)   2/18 (11.11%)   1/17 (5.88%) 
# events   0   2   3   2   2 
Cough * 1           
# participants affected / at risk   2/20 (10.00%)   1/20 (5.00%)   2/17 (11.76%)   1/18 (5.56%)   2/17 (11.76%) 
# events   2   1   2   1   3 
Cough † 1           
# participants affected / at risk   3/20 (15.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   1/14 (7.14%) 
# events   65   0   0   4   1 
Nasal congestion * 1           
# participants affected / at risk   1/20 (5.00%)   2/20 (10.00%)   0/17 (0.00%)   1/18 (5.56%)   2/17 (11.76%) 
# events   1   4   0   1   2 
Nasal congestion † 1           
# participants affected / at risk   4/20 (20.00%)   1/20 (5.00%)   2/17 (11.76%)   0/18 (0.00%)   1/14 (7.14%) 
# events   8   1   4   0   1 
Oropharyngeal discomfort † 1           
# participants affected / at risk   9/20 (45.00%)   3/20 (15.00%)   6/17 (35.29%)   3/18 (16.67%)   1/14 (7.14%) 
# events   51   4   20   56   259 
Oropharyngeal pain * 1           
# participants affected / at risk   3/20 (15.00%)   2/20 (10.00%)   1/17 (5.88%)   1/18 (5.56%)   1/17 (5.88%) 
# events   3   3   1   2   1 
Respiratory tract congestion * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   0   1   0   0 
Rhinitis allergic * 1           
# participants affected / at risk   1/20 (5.00%)   1/20 (5.00%)   0/17 (0.00%)   2/18 (11.11%)   1/17 (5.88%) 
# events   1   1   0   3   1 
Sneezing † 1           
# participants affected / at risk   2/20 (10.00%)   1/20 (5.00%)   3/17 (17.65%)   0/18 (0.00%)   3/14 (21.43%) 
# events   5   1   7   0   7 
Throat irritation † 1           
# participants affected / at risk   1/20 (5.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/14 (0.00%) 
# events   2   0   1   0   0 
Throat tightness † 1           
# participants affected / at risk   1/20 (5.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   0/14 (0.00%) 
# events   1   0   0   1   0 
Upper respiratory tract congestion * 1           
# participants affected / at risk   0/20 (0.00%)   1/20 (5.00%)   4/17 (23.53%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   1   4   0   0 
Wheezing * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   0   2   0   0 
Wheezing † 1           
# participants affected / at risk   1/20 (5.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/14 (0.00%) 
# events   1   0   1   0   0 
Skin and subcutaneous tissue disorders           
Angioedema † 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/14 (0.00%) 
# events   0   0   1   0   0 
Dermatitis allergic * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   0   0   0   1   0 
Dermatitis contact * 1           
# participants affected / at risk   1/20 (5.00%)   0/20 (0.00%)   2/17 (11.76%)   0/18 (0.00%)   1/17 (5.88%) 
# events   1   0   3   0   1 
Eczema * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   0/18 (0.00%)   1/17 (5.88%) 
# events   0   0   0   0   1 
Pruritus † 1           
# participants affected / at risk   7/20 (35.00%)   3/20 (15.00%)   2/17 (11.76%)   1/18 (5.56%)   2/14 (14.29%) 
# events   62   7   2   2   3 
Rash † 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/14 (0.00%) 
# events   0   0   1   0   0 
Rash * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   0/18 (0.00%)   1/17 (5.88%) 
# events   0   0   0   0   1 
Urticaria * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   1/18 (5.56%)   2/17 (11.76%) 
# events   0   0   1   1   2 
Urticaria † 1           
# participants affected / at risk   7/20 (35.00%)   1/20 (5.00%)   6/17 (35.29%)   5/18 (27.78%)   3/14 (21.43%) 
# events   24   2   34   7   15 
Surgical and medical procedures           
Labial frenectomy * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   0/18 (0.00%)   1/17 (5.88%) 
# events   0   0   0   0   1 
Nasal septal operation * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   0   0   0   1   0 
Papilloma excision * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   2/18 (11.11%)   0/17 (0.00%) 
# events   0   0   0   2   0 
Shoulder operation * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   1/18 (5.56%)   0/17 (0.00%) 
# events   0   0   0   1   0 
Tonsillectomy * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/17 (0.00%) 
# events   0   0   1   0   0 
Wisdom teeth removal * 1           
# participants affected / at risk   0/20 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   0/18 (0.00%)   1/17 (5.88%) 
# events   0   0   0   0   1 
Vascular disorders           
Flushing † 1           
# participants affected / at risk   1/20 (5.00%)   0/20 (0.00%)   1/17 (5.88%)   0/18 (0.00%)   0/14 (0.00%) 
# events   1   0   1   0   0 
Events were collected by systematic assessment
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (18.1)



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Refer to the original results published in the Journal of Allergy and Clinical Immunology, Vol 135, Number 5, page 1247 for a full description of the limitations of the current study.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
phone: 301-594-7669
e-mail: DAITClinicalTrialsgov@niaid.nih.gov


Publications of Results:
Other Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00580606     History of Changes
Other Study ID Numbers: DAIT CoFAR4
Study First Received: December 18, 2007
Results First Received: September 28, 2012
Last Updated: December 15, 2015
Health Authority: United States: Food and Drug Administration