Safety, Tolerability, and Immunogenicity of One Dose of NDV 3A Vaccine in People With STAT3-Mutated Hyper-IgE Syndrome
Status:
Terminated
Trial end date:
2018-10-09
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)