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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05009134
• Other study ID #: ENT-ALLERGY-01
• Status: Recruiting
• Start date: June 4, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: March 2022
• Source: Huazhong University of Science and Technology
• Contact: Zheng Liu, Doctor
• Phone: 86 027 83663807
• Email: zhengliuent[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 30, 2022
• Est. primary completion date: March 20, 2022
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergen Immunotherapy
• Allergic Rhinitis
• COVID-19
• Rhinitis
• Rhinitis, Allergic
• SARS-CoV-2

Intervention

Biological:
• There is no intervention in this study.
There is no intervention in this study.

Locations

Country	Name	City	State
China	Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virus-specific antibodies levels in serum and humoral immune response as measured by ELISA or HAI assay	Virus-specific antibodies levels in serum and humoral immune response as measured by ELISA or HAI assay	Jun 2021-Aug 2021
Primary	Frequencies and numbers of circulating T cell subsets, B cell subsets, dendritic cells, NK cells in peripheral blood	Frequencies and numbers of circulating T cell subsets, B cell subsets, dendritic cells, NK cells in peripheral blood	Jun 2021-Aug 2021
Primary	Levels of antigen-specific IgE and IgG4, IFN-?, IL-4, IL-5, IL-10, IL-17A, and IL-21 in serum detected by ELISA	Levels of antigen-specific IgE and IgG4, IFN-?, IL-4, IL-5, IL-10, IL-17A, and IL-21 in serum detected by ELISA	Jun 2021-Aug 2021