The overall aims of this study are to demonstrate that treatment with PVX108 immunotherapy has an acceptable safety profile and is effective for reducing clinical reactivity to peanut protein in children and adolescents with peanut allergy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Arkansas Children's Research Institute
Little Rock, Arkansas, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Ratio of maximum tolerated dose (MTD) of peanut protein at the Week 46 double blind placebo-controlled food challenge (DBPCFC) relative to baseline in children aged 4 to 11 years treated with PVX108 compared to placebo
Time frame: 46 weeks
Ratio of MTD of peanut protein at the Week 71 DBPCFC relative to baseline in children aged 4 to 11 years treated with PVX108 compared to placebo
Time frame: 71 weeks
Percentage of children aged 4 to 11 years treated with PVX108 who achieve an MTD of at least 300 mg, 600 mg and 1000 mg at the Week 46 DBPCFC compared to placebo
Time frame: 46 weeks
Percentage of children aged 4 to 11 years treated with PVX108 who achieve an MTD of at least 300 mg, 600 mg and 1000 mg at the Week 71 DBPCFC compared to placebo
Time frame: 71 weeks
Ratio of cumulative reactive dose (CRD) of peanut protein at the Week 46 DBPCFC relative to baseline in children aged 4 to 11 years treated with PVX108 compared to placebo
Time frame: 46 weeks
Ratio of CRD of peanut protein at the Week 71 DBPCFC relative to baseline in children aged 4 to 11 years treated with PVX108 compared to placebo
Time frame: 71 weeks
Percentage of treatment responders at the Week 46 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo
Time frame: 46 weeks
Percentage of treatment responders at the Week 71 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo
Time frame: 71 weeks
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Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Riley Children's Hospital at IU
Indianapolis, Indiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
IAA Clinical Research
Chevy Chase, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Sydney Children's Hospital
Randwick, New South Wales, Australia
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
...and 4 more locations
Frequency of events of each severity grade during the Week 46 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo
Time frame: 46 weeks
Frequency of events of each severity grade during the Week 71 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo
Time frame: 71 weeks
Treatment emergent adverse events (TEAEs) and Serious adverse events (SAEs) during 45 weeks treatment and 26 weeks following treatment with PVX108 compared to placebo
Incidence and severity of TEAEs (graded according to FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers, 2007) including SAEs, TEAEs leading to study discontinuation, anaphylaxis with temporal association to investigational product (IP) administration, use of epinephrine (adrenaline) as rescue medication after IP administration, and injection site reactions.
Time frame: Up to 74 weeks
Change from baseline in peak expiratory flow
Time frame: Up to 73 weeks
Severity of symptoms upon unintentional exposure to peanut (graded according to FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers, 2007)
Time frame: Up to 73 weeks
Incidence of anti-drug antibodies (ADAs) associated with clinically significant TEAEs
Time frame: Up to 46 weeks
Number of participants with abnormal physical examination data
Time frame: Up to 74 weeks
Incidence of concomitant medication use
Time frame: Up to 74 weeks
Number of participants with abnormal clinical laboratory data
Time frame: Up to 74 weeks
Number of participants with abnormal vital signs
Time frame: Up to 74 weeks