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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02996448 |
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Date of registration:
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16/12/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety, Tolerability, and Immunogenicity of One Dose of NDV 3A Vaccine in People With STAT3-Mutated Hyper-IgE Syndrome
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Scientific title:
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A Phase 2a Study to Evaluate the Safety, Tolerability, and Immunogenicity of One Dose of NDV-3A Vaccine in Patients With STAT3-Mutated Hyper-IgE Syndrome |
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Date of first enrolment:
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November 17, 2016 |
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Target sample size:
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3 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02996448 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Alexandra Freeman, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institute of Allergy and Infectious Diseases (NIAID) |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA:
1. Age 18-55 years.
2. For healthy volunteers: in general good health, without significant medical
illness, physical exam findings, or significant laboratory abnormalities as
determined by the investigator.
3. For participants with AD-HIES: confirmation of diagnosis with a STAT3 mutation.
4. Participants who can get pregnant must be willing to use an acceptable form of
contraception for the duration of participation and have a negative pregnancy
test at screening.
5. Agree to allow storage of biological samples for future research.
EXCLUSION CRITERIA:
1. Has a history of allergic response or other serious reaction to aluminum and/or yeast
products.
2. Has a history of clinically significant allergy including anaphylaxis or other serious
reaction to food, vaccines, or other drugs, that in the opinion of the investigator,
might put the participant at undue risk.
3. Has an active infection (such as S aureus abscess, pneumonia, acute Candida
mucocutaneous infection). Baseline state of chronic infections will be considered by
the PI (eg, chronic Pseudomonas infection in lung).
4. Has an active infection with hepatitis B, hepatitis C, or HIV.
5. Has received or is planning to receive any investigational drug, investigational
vaccine, or investigational device within four weeks prior to vaccination, or at any
other time during their participation in the study.
6. Has received or is planning to receive any other live vaccine within three weeks
before vaccination or for three weeks after vaccination.
7. Self-reported current alcohol abuse or addiction.
8. Self-reported current illicit drug abuse or addiction, or drug screen positive for
illicit drugs.
9. Current or planned use, within 3 weeks before vaccination, of any medications or
treatments that may alter immune responses to the study vaccine (eg, immunosuppressive
medications including systemic corticosteroids, cyclosporine, tacrolimus, cytotoxic
drugs, Bacillus Calmette-Guerin, monoclonal antibodies, or radiation therapy).
Topical, intranasal, or inhaled immunosuppressants such as corticosteroids will be
allowed.
10. Current or planned use within 2 weeks before vaccination of immune globulin
replacement.
11. Has any of the following laboratory abnormalities at the screening visit:
1. Alanine transaminase (ALT), aspartate transaminase (AST), and/or alkaline
phosphatase (ALP) > 1.5 times the upper limit of normal (ULN).
2. Total bilirubin level > 1.5 times the ULN
3. Serum creatinine level > 1.5 times the ULN
4. Absolute neutrophil count < 750 cells/microliter
5. Hemoglobin < 9 mg/dL
6. Platelet count < 100,000
12. Refusal or inability to comply with study procedures to the extent that it is
potentially harmful to the participant or to the integrity of the study data.
13. Has donated blood/plasma within four weeks before vaccination.
14. Is pregnant or breastfeeding, or intends to become pregnant over the course of the
study.
15. Is unable to commit to the follow-up visits and or has unreliable access to a
telephone for follow-up contacts, either by self-admission (self-reporting) or in the
opinion of the investigator.
16. Any other condition the investigator believes would interfere with the participant s
ability to provide informed consent, comply with study instructions, or that might
confound the interpretation of the study results or put the participant at undue risk.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Autosomal-dominant Hyper-IgE Syndrome
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Intervention(s)
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Drug: NDV-3A
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Primary Outcome(s)
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Percent of Each Group With at Least a Four-fold Increase in Anti rAls3 Antibody Titer.
[Time Frame: 2 weeks after vaccination]
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Secondary Outcome(s)
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Anti-Als3 Antibody Titers at 6 Months After Vaccination in Patients With AD HIES and Healthy Volunteers.
[Time Frame: 6 months]
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Number of Participants With Serious Adverse Events That Led to Study Termination.
[Time Frame: Up to 6 months]
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Secondary ID(s)
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170017
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17-I-0017
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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