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

Huazhong University of Science and Technology

Status: Unknown

Conditions: Allergic Rhinitis; SARS-CoV-2; Allergen Immunotherapy

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

Study type: Observational

Funder types: Other

Identifiers

NCT05009134

ENT-ALLERGY-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

120 participants in 3 patient groups

Control

Description:

18-55 years, healthy

Treatment:

Biological: There is no intervention in this study.

Allergic rhinitis

Description:

patients with AR without AIT

Treatment:

Biological: There is no intervention in this study.

Allergen immunotherapy

Description:

patients with AR with AIT for more than 1 year

Treatment:

Biological: There is no intervention in this study.