Clinical trialNCT02996448TerminatedPhase 2Interventional

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

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment3Autosomal-dominant Hyper-IgE Syndrome

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Alexandra Freeman, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

National Institutes of Health Clinical Center
Bethesda, Maryland, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

NDV-3A

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 17 Nov 2016
Primary completion: 22 Jul 2018
Completion: 9 Oct 2018
Last update posted: 30 Jun 2020
Registered enrollment: 3
Registry id: NCT02996448

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.