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NCT02996448 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability, and Immunogenicity of One Dose of NDV 3A Vaccine in People With STAT3-Mutated Hyper-IgE Syndrome
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT02996448 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 3 participants.
The verdict
NCT02996448, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG NDV-3A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2016-11-17 |
| Est. Completion | 2018-10-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02996448
The ClinicalTrials.gov registry entry for NCT02996448 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NDV-3A is the first listed.
NCT02996448 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02996448 about?
NCT02996448 is a clinical study titled "Safety, Tolerability, and Immunogenicity of One Dose of NDV 3A Vaccine in People With STAT3-Mutated Hyper-IgE Syndrome". 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 t...
What is the current status of trial NCT02996448?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2016-11-17. Estimated completion is 2018-10-09.
What interventions are being tested in trial NCT02996448?
The interventions under investigation include: NDV-3A (DRUG).
Who is sponsoring clinical trial NCT02996448?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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