Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Vedanta Biosciences, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
This is a single-center, randomized, double-blind trial with four arms evaluating VE416 as pretreatment or concurrent treatment in comparison to low-dose peanut oral immunotherapy (PNOIT) alone.
In this research study the investigators want to learn more about an investigational medicine called VE416 in combination with vancomycin (an antibiotic) while undergoing peanut oral immunotherapy. VE416 is a combination of dormant (inactive) bacteria given in a capsule. The bacteria are reactivated once they reach participants intestines and in combination with peanut flour may help to prevent participants from getting sick (upset stomach, breathing problems, and skin problems) when participants come into contact with peanuts.
The investigators are doing this research study to find out if VE416 in combination with vancomycin (an antibiotic) while undergoing peanut oral immunotherapy can help people with peanut allergy. VE416 is a consortium of commensal, or "friendly", dormant (inactive) bacteria given in a capsule. The bacteria are reactivated once they reach participants intestines. The investigators also want to find out if VE416 with peanut oral immunotherapy is safe to take without causing too many side effects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vancomycin plus VE416 before PNOIT | Experimental | active vancomycin plus VE416 before PNOIT |
|
| Vancomycin plus VE416 with PNOIT | Experimental | active vancomycin plus active VE416 with active PNOIT |
|
| Placebo plus VE416 with PNOIT | Experimental | placebo vancomycin plus active VE416 with active VE416 |
|
| Placebo plus placebo with PNOIT | Active Comparator | placebo vancomycin and placebo VE416 with active peanut oral immunotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin plus VE416 before PNOIT | Combination Product | Vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks followed by PNOIT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint- Phase 1b | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 7 weeks |
| Primary Endpoint- Phase II | The geometric mean of the maximum tolerated dose (MTD) of peanut protein at DBPCFC1 | 23 weeks, with 24 week Post-Phase II maintenance phase followed by a DBPCFC |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint- Efficacy | The percentage of patients tolerating 600 mg (1030 mg cumulative) at DBPCFC1 without treatment | 54 weeks |
| Secondary Endpoint- Safety | The occurrence of treatment related adverse events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wayne G Shreffler, MD, PhD | Contact | 617-726-6147 | wshreffler@mgh.harvard.edu | |
| Jannat Gill, BDS, MPH | Contact | 617-643-8683 | jgill0@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Wayne G Shreffler, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33463542 | Derived | Berin MC. Dysbiosis in food allergy and implications for microbial therapeutics. J Clin Invest. 2021 Jan 19;131(2):e144994. doi: 10.1172/JCI144994. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 7, 2026 | Apr 29, 2026 | 6 |
| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
Not provided
Not provided
| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
Not provided
Not provided
This is a single-center, randomized, double-blind trial with four arms evaluating VE416 as pretreatment or concurrent treatment in comparison to low-dose peanut oral immunotherapy (PNOIT) alone.
Not provided
Not provided
Not provided
| Vancomycin plus VE416 with PNOIT | Combination Product | Placebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by Vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks with concomitant PNOIT |
|
| Placebo plus VE416 with PNOIT | Combination Product | Placebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by placebo for vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks with concomitant PNOIT |
|
| Placebo plus placebo with PNOIT | Combination Product | Placebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by placebo for vancomycin PO QD x 5 days, followed by placebo for VE416 PO QD x 6 weeks with concomitant PNOIT |
|
| 54 weeks |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |