- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05009134
Influences of Allergic Rhinitis and Allergen Immunotherapy on SARS-CoV-2 Vaccination
Influences of Allergic Rhinitis and Allergen Immunotherapy on Human Antibody Responses to SARS-CoV-2 Vaccination
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Allergic rhinitis (AR) is a disorder caused by hypersensitivity of the immune system to harmless allergens in the environment, which represents a global public health problem affecting up to 20-50% of the population. Allergen immunotherapy (AIT) is the only effective treatment that not only has disease-modifying property but also confers long-term clinical benefit after cessation of treatment for AR patients. Vaccination is one of the most powerful interventions for reducing disability and death caused by infectious disease. Immunization with the inactivated SARS-CoV-2 Vaccine remains the most effective strategy to combat COVID-19 infections. Nevertheless, the influences of allergic rhinitis and allergen immunotherapy on SARS-CoV-2 vaccination are still unknown.
Objectives: To investigate if AR and AIT will influence the humoral response to SARS-CoV-2 vaccination in adults.
Design and trial size: This is a prospective study. A total of approximately 120 subjects, 18-55 years old, including 40 healthy subjects, 40 patients with AR without AIT, and 40 patients with AR with AIT for more than 1 year, will be enrolled in this study.
Intervention and duration: All of the study participants will be vaccinated with an 2 doses inactivated vaccine against SARS-CoV-2 (COVILO). Peripheral blood samples will be collected at baseline (prior to vaccinate), 7 and 30 after first vaccine, and, 7 and 30 after second vaccine. One-month additional data analysis leads to the trial duration of 3 months.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Zheng Liu, doctor
- Phone Number: 86 027 83663807
- Email: zhengliuent@hotmail.com
Study Contact Backup
- Name: Rong-Fei Zhu, Doctor
- Email: zrf13092@163.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Recruiting
- Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Contact:
- Zheng Liu, doctor
- Phone Number: 86 027 83663807
- Email: zhengliuent@hotmail.com
-
Principal Investigator:
- Zheng Liu, doctor
-
Contact:
- Rong-Fei Zhu, Doctor
- Phone Number: 86 027 83663809
- Email: zrf13092@163.com
-
Principal Investigator:
- Rong-Fei Zhu, Doctor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
18-55 years; healthy subjects, patients with AR without AIT, or patients with AR with AIT for more than 1 year
Exclusion Criteria:
- who infected with COVID-19 previously
- Cannot finish the follow up
- Previous allergic to other vaccines
- who have had severe immunologic, cardiac, liver or metabolic disease, tumors, allergic diseases, or chronic infection,
- pregnancy or breastfeeding
- Suffered from airway infection or severe infectious diseases in the past 3 months, prior to this study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control
18-55 years, healthy
|
There is no intervention in this study.
|
Allergic rhinitis
patients with AR without AIT
|
There is no intervention in this study.
|
Allergen immunotherapy
patients with AR with AIT for more than 1 year
|
There is no intervention in this study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Virus-specific antibodies levels in serum and humoral immune response as measured by ELISA or HAI assay
Time Frame: Jun 2021-Aug 2021
|
Virus-specific antibodies levels in serum and humoral immune response as measured by ELISA or HAI assay
|
Jun 2021-Aug 2021
|
Frequencies and numbers of circulating T cell subsets, B cell subsets, dendritic cells, NK cells in peripheral blood
Time Frame: Jun 2021-Aug 2021
|
Frequencies and numbers of circulating T cell subsets, B cell subsets, dendritic cells, NK cells in peripheral blood
|
Jun 2021-Aug 2021
|
Levels of antigen-specific IgE and IgG4, IFN-γ, IL-4, IL-5, IL-10, IL-17A, and IL-21 in serum detected by ELISA
Time Frame: Jun 2021-Aug 2021
|
Levels of antigen-specific IgE and IgG4, IFN-γ, IL-4, IL-5, IL-10, IL-17A, and IL-21 in serum detected by ELISA
|
Jun 2021-Aug 2021
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Zheng Liu, Doctor, Tongji Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENT-ALLERGY-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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