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Celiac Disease Vaccine

A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)

Phase 2
Waitlist Available
Research Sponsored by ImmusanT, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 79 to 93 days after baseline

Summary

This trial tests Nexvax2, an injection treatment, in adults with celiac disease who have been on a gluten-free diet for a long time. The goal is to see if Nexvax2 can help their immune systems tolerate gluten better. The study includes different phases.

Eligible Conditions
  • Not a Treatment Study
  • Malabsorption Syndrome
  • Celiac Disease
  • Gastrointestinal Disease
  • Autoimmune Diseases
  • Celiac disease
  • Gastrointestinal Disorders
  • Gluten Intolerance
  • Intestinal Diseases

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~79 to 93 days after baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 79 to 93 days after baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy of Nexvax2 compared to placebo in reducing Celiac Disease (CeD) associated GI symptoms.
Secondary study objectives
Evaluate efficacy of Nexvax 2 compared with placebo on immune-system activation after the first MFC containing gluten.
Evaluate efficacy of Nexvax2 compared with placebo in reducing CeD associated GI symptom sub-domains.
Evaluate efficacy of Nexvax2 compared with placebo in reducing individual GI symptoms.
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nexvax2Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nexvax2
2015
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

ImmusanT, Inc.Lead Sponsor
3 Previous Clinical Trials
59 Total Patients Enrolled
Robert Anderson, PhD, FRACPStudy ChairImmusanT, Inc.
1 Previous Clinical Trials
14 Total Patients Enrolled
~20 spots leftby Dec 2025
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