NCT02996448

Safety, Tolerability, and Immunogenicity of One Dose of NDV 3A Vaccine in People With STAT3-Mutated Hyper-IgE Syndrome

Terminated Phase 2 Results posted Last updated 30 June 2020

What this trial tests

Phase 2 trial testing NDV-3A in Autosomal-dominant Hyper-IgE Syndrome in 3 participants. Terminated before completion.

Timeline

17 November 2016

Primary endpoint
22 July 2018

9 October 2018

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	3
Start date	17 November 2016
Primary completion	22 July 2018
Estimated completion	9 October 2018
Sites	1 location across United States

Drugs / interventions tested

• NDV-3A — full drug profile →

Conditions studied

• Autosomal-dominant Hyper-IgE Syndrome — all drugs for Autosomal-dominant Hyper-IgE Syndrome →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 55, any sex, with Autosomal-dominant Hyper-IgE Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Serious Adverse Events That Led to Study Termination. Secondary · Up to 6 months

Group	Value	95% CI
Vaccination Group- Single Arm Study	1

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Vaccination Group- Single Arm Study

Serious: 1/3 (33%)

Deaths: 0/3

Serious adverse events (1 terms)

Reaction	System	Vaccination Group- Single …
Anaphylaxis	Immune system disorders	—

Other adverse events (7 terms — click to expand)

Reaction	System	Vaccination Group- Single …
Eczema exacerbation	Skin and subcutaneous tissue disorders	—
Injection site pain	Musculoskeletal and connective tissue disorders	—
Nausea	Gastrointestinal disorders	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—
Dizziness	Nervous system disorders	—
fatigue	Nervous system disorders	—
Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Anaphylaxis.

Data from ClinicalTrials.gov NCT02996448 adverse events section.

Sponsor's own description

Background:

AD-HIES is a disease that weakens the immune system. It puts people at risk for infections, particularly Staph and Candida infections. Researchers want to test a vaccine that may help keep people from getting these infections, which would help people with AD-HIES.

Objective:

To test the new vaccine NDV-3A for protection against infection from the yeast Candida and the bacterium Staphylococcus aureus (Staph).

Eligibility:

Adults ages 18-55 who have AD-HIES

Healthy volunteers ages 18-55

Design:

Participants will have 6-7 study visits over 6-7 months. They will also be contacted by phone in between some visits.

Participants will be screened with a medical history, physical exam, and blood and urine tests.

Participants will have 2 baseline visits. They will have repeat the screening tests. They will have samples of saliva, stool, skin, mucus (oral, nasal, and/or vaginal) collected. Vaginal and stool samples are optional. Any eczema on their skin will be looked at.

Participants will fill out symptom diary cards to record how they feel.

Participants will have the NDV-3A vaccine injected into a muscle in the arm.

Participants will return the next 2 days. They will have a physical exam. Blood will be collected.

Participants will have 2 more follow-up visits at the NIH. They will have a physical exam. They will have blood, saliva, stool, skin, vaginal fluid, and/or mucus samples collected. Vaginal and stool samples are optional.

Participants will be called once a month for 5 months after the vaccination. There is an optional visit about 6 weeks after the vaccination. Participants will provide a blood sample at this visit.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunity against fungi.
   Lionakis MS, Iliev ID, Hohl TM. · · 2017 · cited 102× · PMID 28570272 · DOI 10.1172/jci.insight.93156
2. Innate Inspiration: Antifungal Peptides and Other Immunotherapeutics From the Host Immune Response.
   Mercer DK, O'Neil DA. · · 2020 · cited 34× · PMID 33072081 · DOI 10.3389/fimmu.2020.02177
3. Hyper IgE Syndromes: Understanding, Management, and Future Perspectives: A Narrative Review.
   Salehi M, Neshati Z, Ahanchian H, Tafrishi R, et al · · 2025 · cited 7× · PMID 40114756 · DOI 10.1002/hsr2.70497
4. Next-generation antifungal drugs: Mechanisms, efficacy, and clinical prospects.
   Lu X, Zhou J, Ming Y, Wang Y, et al · · 2025 · cited 2× · PMID 40893690 · DOI 10.1016/j.apsb.2025.06.013