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NDV-3A Vaccine in STAT3-Mutated Hyper-IgE Syndrome
NCT02996448Phase 2
Key facts
- Status
- Terminated
- Start
- Nov 2016
- Primary completion
- Jul 2018
- Countries
- 1
- Sponsor
- National Institute of Allergy and Infectious Diseases
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- NDV-3 vaccine
- Conditions
- Autosomal dominant hyperimmunoglobulin E syndrome (AD-HIES)
01
Overview
Phase 2, open-label, single-arm trial of NDV-3 vaccine in Autosomal dominant hyperimmunoglobulin E syndrome (AD-HIES), sponsored by National Institute of Allergy and Infectious Diseases. Primary endpoint: Percent of Each Group With at Least a Four-fold Increase in Anti rAls3 Antibody Titer at 2 weeks. Started Nov 2016; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
NDV-3A vaccine
Single dose of 0.5 mL (300 micrograms of rAls3) administered via IM injection.
03
Who it enrols
Adults 18-55 with STAT3-mutated AD-HIES or healthy volunteers.
04
Endpoints
Primary
Percent of Each Group With at Least a Four-fold Increase in Anti rAls3 Antibody Titer
Secondary
Number of Participants With Serious Adverse Events That Led to Study Termination
Anti-Als3 Antibody Titers at 6 Months After Vaccination in Patients With AD HIES and Healthy Volunteers
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