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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVX108 50 nmol in adolescents | Experimental | Twelve 4-weekly intradermal (ID) doses of PVX108 at 50 nmol in adolescents (Cohort 1) |
|
| Placebo in adolescents | Placebo Comparator | Twelve 4-weekly ID doses of placebo matching PVX108 in adolescents (Cohort 1) |
|
| PVX108 5 nmol in children | Experimental | Twelve 4-weekly ID doses of PVX108 at 5 nmol in children (Cohort 2) |
|
| PVX108 50 nmol in children | Experimental | Twelve 4-weekly ID doses of PVX108 at 50 nmol in children (Cohort 2) |
|
| Placebo in children | Placebo Comparator | Twelve 4-weekly ID doses of placebo matching PVX-108 in children (Cohort 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVX-108 | Biological | PVX108 comprises a mixture of peptides that represent sequences from peanut allergens |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 46 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of MTD of peanut protein at the Week 46 DBPCFC relative to baseline in adolescents aged 12 to 17 years treated with PVX108 compared to placebo | 46 weeks | |
| Ratio of MTD of peanut protein at the Week 71 DBPCFC relative to baseline in adolescents aged 12 to 17 years treated with PVX108 compared to placebo |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Vickery, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Research Institute | Little Rock | Arkansas | 72202 | United States | ||
| Peninsula Research Associates |
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| Placebo | Biological | Matching placebo comprises the formulation vehicle without peptides |
|
| 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 | 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 | 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 | 71 weeks |
| Percentage of treatment responders at the Week 46 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo | 46 weeks |
| Percentage of treatment responders at the Week 71 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo | 71 weeks |
| 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 | 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 | 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. | Up to 74 weeks |
| Change from baseline in peak expiratory flow | 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) | Up to 73 weeks |
| Incidence of anti-drug antibodies (ADAs) associated with clinically significant TEAEs | Up to 46 weeks |
| Number of participants with abnormal physical examination data | Up to 74 weeks |
| Incidence of concomitant medication use | Up to 74 weeks |
| Number of participants with abnormal clinical laboratory data | Up to 74 weeks |
| Number of participants with abnormal vital signs | Up to 74 weeks |
| 71 weeks |
| Percentage of adolescents aged 12 to 17 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 | 46 weeks |
| Percentage of adolescents aged 12 to 17 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 | 71 weeks |
| Ratio of CRD of peanut protein at Week 46 DBPCFC relative to baseline in adolescents aged 12 to 17 years treated with PVX108 compared to placebo | 46 weeks |
| Ratio of CRD of peanut protein at Week 71 DBPCFC relative to baseline in adolescents aged 12 to 17 years treated with PVX108 compared to placebo | 71 weeks |
| Percentage of treatment responders at the Week 46 DBPCFC in adolescents aged 12 to 17 years treated with PVX108 compared to placebo | 46 weeks |
| Percentage of treatment responders at the Week 71 DBPCFC in adolescents aged 12 to 17 years treated with PVX108 compared to placebo | 71 weeks |
| Frequency of events of each severity grade during the Week 46 DBPCFC in adolescents aged 12 to 17 years treated with PVX108 compared to placebo | 46 weeks |
| Frequency of events of each severity grade during the Week 71 DBPCFC in adolescents aged 12 to 17 years treated with PVX108 compared to placebo | 71 weeks |
| Changes from baseline in allergen specific immunoglobulins after 45 weeks treatment with PVX108 compared to placebo | Up to 74 weeks |
| Changes from baseline in cellular immune response after 45 weeks treatment with PVX108 compared to placebo: Exploratory | Up to 74 weeks |
| Changes from baseline in titrated peanut skin prick test (SPT) response after 45 weeks treatment with PVX108 compared to placebo | Up to 74 weeks |
| Proportion of participants in each cohort who develop treatment-induced or treatment-enhanced ADAs during 45 weeks treatment with PVX108 compared to placebo | 45 weeks |
| Change from baseline in Food Allergy Related Quality of Life Questionnaire Child Form (FAQLQ-CF) score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in children enrolled in Cohort 2 treated with PVX108 compared to placebo | Up to 71 weeks |
| Change from baseline in FAQLQ-Teenager Form (FAQLQ-TF) score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in adolescents enrolled in Cohort 1 treated with PVX108 compared to placebo | Up to 71 weeks |
| Change from baseline in Food Allergy Independent Measure (FAIM) score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in children enrolled in Cohort 2 treated with PVX108 compared to placebo | Up to 71 weeks |
| Change from baseline in FAIM score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in adolescents enrolled in Cohort 1 treated with PVX108 compared to placebo | Up to 71 weeks |
| Change from baseline in FAQLQ-Parent Form (FAQLP-PF) score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in children enrolled in Cohort 2 treated with PVX108 compared to placebo | Up to 71 weeks |
| Change from baseline in FAQLQ-Parent Form Teenager (FAQLQ-PFT) score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in adolescents enrolled in Cohort 1 treated with PVX108 compared to placebo | Up to 71 weeks |
| Rolling Hills Estates |
| California |
| 90274 |
| United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30329 | United States |
| Riley Children's Hospital at IU | Indianapolis | Indiana | 462020 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21205 | United States |
| IAA Clinical Research | Chevy Chase | Maryland | 20815 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Sydney Children's Hospital | Randwick | New South Wales | Australia |
| The Children's Hospital at Westmead | Westmead | New South Wales | Australia |
| Queensland Children's Hospital | South Brisbane | Queensland | 4101 | Australia |
| Women's and Children's Hospital | North Adelaide | South Australia | Australia |
| The Royal Children's Hospital Melbourne | Parkville | Victoria | Australia |
| Perth Children's Hospital | Nedlands | Western Australia | Australia |
| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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