Influences of Allergic Rhinitis and Allergen Immunotherapy on SARS-CoV-2 Vaccination

March 16, 2022 updated by: Zheng Liu, Huazhong University of Science and Technology

Influences of Allergic Rhinitis and Allergen Immunotherapy on Human Antibody Responses to SARS-CoV-2 Vaccination

The study is designed to assess whether allergic rhinitis and allergen immunotherapy affect the humoral response to SARS-CoV-2 Vaccination in adults. This is a prospective study enrolling a total of approximately 120 subjects, 18-55 years old.

Study Overview

Status

Recruiting

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

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Zheng Liu, doctor
        • Contact:
        • Principal Investigator:
          • Rong-Fei Zhu, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

18-55 years; healthy subjects, patients with AR without AIT, or patients with AR with AIT for more than 1 year

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:

  1. who infected with COVID-19 previously
  2. Cannot finish the follow up
  3. Previous allergic to other vaccines
  4. who have had severe immunologic, cardiac, liver or metabolic disease, tumors, allergic diseases, or chronic infection,
  5. pregnancy or breastfeeding
  6. Suffered from airway infection or severe infectious diseases in the past 3 months, prior to this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
18-55 years, healthy
Biological: There is no intervention in this study.
There is no intervention in this study.
Allergic rhinitis
patients with AR without AIT
Biological: There is no intervention in this study.
There is no intervention in this study.
Allergen immunotherapy
patients with AR with AIT for more than 1 year
Biological: There is no intervention in this study.
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

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Collaborators

National Natural Science Foundation of China

Investigators

  • Study Chair: Zheng Liu, Doctor, Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2021

Primary Completion (Anticipated)

March 20, 2022

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

August 10, 2021

First Submitted That Met QC Criteria

August 10, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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