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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks followed by PNOIT
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 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
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGPrimary Endpoint- Phase 1b
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 7 weeks
Primary Endpoint- Phase II
The geometric mean of the maximum tolerated dose (MTD) of peanut protein at DBPCFC1
Time frame: 23 weeks, with 24 week Post-Phase II maintenance phase followed by a DBPCFC
Secondary Endpoint- Efficacy
The percentage of patients tolerating 600 mg (1030 mg cumulative) at DBPCFC1 without treatment
Time frame: 54 weeks
Secondary Endpoint- Safety
The occurrence of treatment related adverse events
Time frame: 54 weeks
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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